Completed

NCT Number: NCT03583099

The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3)

A prospective, multicenter study including a cross-section validation to define sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant Chronic Obstructive Pulmonary Disease (COPD), and its impact on clinical care across a broad range of primary care settings in a cluster randomized controlled clinical trial.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LANet, Los Angeles, California, United States

About this study

This is a large prospective, multi-center study explore the impact of the CAPTURE tool on clinical care and patient outcomes across a broad range of primary care settings in a cluster randomized controlled clinical trial.

The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD.

The CAPTURE study will enroll approximately 5,000 patients across 100 participating primary care clinics associated with practice-based research networks (PBRNs). Participants will be assessed with the CAPTURE Tool and have research spirometry testing.

Participating primary care practices will be randomized in a 1:1 fashion to one of the following interventions:

Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education (CAPTURE+ COPD education).
Arm 2: Practice clinicians will receive basic COPD education only (COPD education) and will be blinded to patient-level CAPTURE information.

A predefined subgroup of participants will undergo longitudinal follow-up at 12 months to determine the impact of the CAPTURE Tool on clinical care and patient outcomes. Participant reported data will be collected through in-person visits, telephone and mail-based methodologies, depending upon practice site preferences and feasibility. Clinic site data will also be collected from the medical record to assess for changes in practice-level care.

Primary outcome measure changes have been made in this ClinicalTrials.gov record because a planned part of the primary outcome measure was inadvertently missing from the initial draft of the protocol. It has been added to this ClinicalTrials.gov record to align with the most recent IRB-approved protocol. Secondary outcome measure changes were initiated as driven by the literature and advances in accepted methods of management and categorization of patients with COPD. An additional secondary outcome measure was added due to the COVID-19 pandemic. The changes have been made in ClinicalTrials.gov to align with the most recent IRB-approved protocol.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 45 - 80 years
4. Able to read and speak English or Spanish

Exclusion criteria

1. Previous clinician provided diagnosis of COPD
2. Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days
3. Participants unable to perform spirometry due to any of the following conditions within the past 30 days

Chest surgery
Abdominal surgery
Eye surgery
Heart attack
Stroke

Treatment and study plan

COPD plus CAPTURE education and patient-level information

Other

Basic COPD Education plus CAPTURE education and patient-level CAPTURE information will be provided to all practice personnel randomized to the 'CAPTURE + COPD Education' arm.

COPD Education Only

Other

Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.

Primary outcomes

Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD

Time frame: Baseline to 12 months

Proportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Secondary outcomes

Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination.

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below.

Time frame: Baseline to 12 months
Proportion of CAPTURE+ participants currently smoking at the baseline visit who have any of the components of the Aim 3 primary endpoint: 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

OR
- clinical counseling or recommendation for smoking cessation, 2) referral to a smoking cessation program, 3) referral to a smoking quit line, 4) newly prescribed medication for smoking cessation.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation.

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation.

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants

Time frame: Baseline to 12 months

The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact.

CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (<350 L/min for males,<250 L/min for females). Higher values = higher likelihood of COPD.

The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months.

Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change.

The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Proportion of CAPTURE+ Participants Who Experience Exacerbations.

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up.
Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of participants with clinically significant COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. (composite endpoint)

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.

A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation.

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of participants with spirometric COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD.

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.

A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation.

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination.

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint

Time frame: Baseline to 12 months

Proportion of participants with Mild COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD With a New Diagnosis of COPD

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.

A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation.

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination.

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of participants with preserved ratio, impaired spirometry (PRISm) who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Clinical Spirometry Testing.

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With New Diagnosis of COPD.

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.

A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With a Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Pulmonary Rehabilitation.

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Receive a Recommendation for or Administration of Influenza Vaccination.

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of participants with symptomatic non-obstructed (SNO) meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC<0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Clinical Spirometry Testing.

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.

The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) With a New Diagnosis of COPD

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.

The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.

The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.

The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Pulmonary Rehabilitation.

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.

The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Who Receive a Recommendation or Administration of Influenza Vaccination.

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10.

The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of CAPTURE+ participants enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of CAPTURE+ participants enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Newly Diagnosed With COPD

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Newly Diagnosed With COPD

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Have Received a Recommendation for, or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled Before March 20, 2019

Time frame: Baseline to 12 months

The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact.

CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (<350 L/min for males,<250 L/min for females). Higher values = higher likelihood of COPD.

The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months.

Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change.

The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled on or After March 20, 2019

Time frame: Baseline to 12 months

The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact.

CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (<350 L/min for males,<250 L/min for females). Higher values = higher likelihood of COPD.

The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months.

Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change.

The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Exacerbations.

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up.
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Exacerbations.

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Meet Any of Components of the Primary Endpoints.

Time frame: Baseline to 12 months

Proportion of participants with clinically significant COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 Who Meet Any of Components of the Primary Endpoints.

Time frame: Baseline to 12 months

Proportion of participants with clinically significant COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 a New Diagnosis of COPD

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)

Time frame: Baseline to 12 months

Clinically significant COPD = post-bronchodilator FEV1/FVC <0.7, plus: 1) FEV1 < 60% predicted or 2) > 1 exacerbation like event in the last year.

The generalized estimating equation (GEE) model for the Proportion:

Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome.

EUC proportion = intercept. Intervention proportion = intercept + slope.

Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)

When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Proportion of Participants With Clinically Significant COPD Enrolled After August 13, 2020 Who Receive a Recommendation for or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months.
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint

Time frame: Baseline to 12 months

Proportion of participants with spirometric COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint

Time frame: Baseline to 12 months

Proportion of participants with spirometric COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)

Time frame: Baseline to 12 months

Spirometric COPD: post-bronch FEV1/FVC <0.7. If only pre-bronch spirometry is available and FEV1/FVC < 0.65, subject will be considered to have COPD.

The generalized estimating equation (GEE) model for the Proportion:

Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome.

EUC proportion = intercept. Intervention proportion = intercept + slope.

Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)

When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment (Abbreviated as Proportion in the Description)

Time frame: Baseline to 12 months

Spirometric COPD: post-bronch FEV1/FVC <0.7. If only pre-bronch spirometry is available and FEV1/FVC < 0.65, participant will be considered to have COPD.

The generalized estimating equation (GEE) model for the Proportion:

Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome.

EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)

When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Proportion of Mild COPD Participants Enrolled Before 3/20/2019 With Any of :1) Clinical Spirometry Referral, 2) New COPD Diagnosis, 3) Newly Prescribed Respiratory Medication, 4) Respiratory Specialist Referral, 5) Referral/Completion of Pulmonary Rehab

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory

Mild COPD = post-bronch FEV1/FVC<0.7 plus 1) FEV1 ≥ 60% and 2) No prior COPD exacerbation

The generalized estimating equation (GEE) model for the Proportion:

Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) aren't based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome

EUC proportion = intercept. Intervention proportion = intercept + slope Intervention - EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)

When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcome between subjects in same practice
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint

Time frame: Baseline to 12 months

Proportion of participants with mild COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)

Time frame: Baseline to 12 months

Mild COPD = post-bronch FEV1/FVC<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.

The generalized estimating equation (GEE) model for the Proportion:

Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome.

EUC proportion = intercept. Intervention proportion = intercept + slope.

Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference).

When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)

Time frame: Baseline to 12 months

Mild COPD = post-bronchodilator FEV1/FVC<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.

The generalized estimating equation (GEE) model for the Proportion:

Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome

EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)

When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication (Abbreviated as Proportion in the Description)

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Mild COPD = post-bronchodilator FEV1/FVC<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD

The generalized estimating equation (GEE) model for the Proportion:

Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome

EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference)

When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and c
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With New Diagnosis of COPD

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With New Diagnosis of COPD

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) = participants without spirometrically defined COPD who have post-bronch FEV1 < 80% predicted.

The generalized estimating equation (GEE) model for the Proportion:

Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome.

EUC proportion = intercept. Intervention proportion = intercept + slope.

Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference).

When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice.
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination

Time frame: Baseline to 12 months

Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.

Time frame: Baseline to 12 months

Proportion of participants with symptomatic non-obstructed (SNO) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)

Time frame: Baseline to 12 months

SNO = post-bronch FEV1/FVC ≥ 0.7 and post-bronch FEV1 ≥ 80% predicted and a COPD Assessment Test (CAT) score ≥ 10. The CAT is scored 0-40. Higher score = more severe COPD

The generalized estimating equation (GEE) model for the Proportion:

Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits not based on raw data proportions. Reported units are on the scale from 0% - 100%. Ie. 50 = 50% met outcome

EUC proportion = intercept. Intervention proportion = intercept + slope

Intervention - EUC proportion = slope. Ie 10 = Intervention met outcome 10% > EUC (absolute difference)

When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 With a New Diagnosis of COPD

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Newly Prescribed Respiratory Medication

Time frame: Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition.

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.

Time frame: Baseline to 12 months

Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Received Over-the-counter Patches/Gum for Smoking Cessation

Time frame: Baseline to 12 months
Proportion of CAPTURE+ Participants Who Experience Hospitalizations

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Number of Enrolled CAPTURE+ Participants Who Experience Mortality

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Hospitalizations

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Hospitalizations

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Number of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Mortality.

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Number of CAPTURE+ Participants Enrolled After March 20, 2019 Who Experience Mortality.

Time frame: Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females.

CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

COPD Foundation
Duke University
High Plains Research Network
L.A. Net Community Health Resource Network
National Heart, Lung, and Blood Institute (NHLBI)
National Jewish Health
Oregon Health and Science University
University of Kentucky
University of Michigan
University of Minnesota
Wake Forest University Health Sciences

Registry information

Official study title

The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care

Acronym: CAPTURE

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Jul 11, 2018
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

About this study

Who can participate

Treatment and study plan

COPD plus CAPTURE education and patient-level information

COPD Education Only

Primary outcomes

Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD

Secondary outcomes

Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing

Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD

Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication

Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment

Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation

Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination.

Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below.

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation.

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program

Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation.

12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants

Proportion of CAPTURE+ Participants Who Experience Exacerbations.

Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint.

Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing

Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD

Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication

Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment

Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation.

Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination

Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint.

Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing

Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD.

Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication

Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment

Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation.

Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination.

Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint

Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing

Proportion of Participants With Mild COPD With a New Diagnosis of COPD

Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication

Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment

Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation.

Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination.

Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint.

Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Clinical Spirometry Testing.

Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With New Diagnosis of COPD.

Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With a Newly Prescribed Respiratory Medication

Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred to a Specialist for Respiratory Evaluation/Treatment

Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Pulmonary Rehabilitation.

Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Receive a Recommendation for or Administration of Influenza Vaccination.

Proportion of Participants With Symptomatic Non-obstructed (SNO) Meet Any of the Components of the Primary Endpoint.

Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Clinical Spirometry Testing.

Proportion of Participants With Symptomatic Non-obstructed (SNO) With a New Diagnosis of COPD

Proportion of Participants With Symptomatic Non-obstructed (SNO) Newly Prescribed Respiratory Medication

Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred to a Specialist for Respiratory Evaluation/Treatment

Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Pulmonary Rehabilitation.

Proportion of Participants With Symptomatic Non-obstructed (SNO) Who Receive a Recommendation or Administration of Influenza Vaccination.

Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.

Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.

Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing

Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing

Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Newly Diagnosed With COPD

Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Newly Diagnosed With COPD

Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication

Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication

Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment

Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation

Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation