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Completed

NCT Number: NCT03653611

The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 2)

This is a qualitative research exploration engaging clinical staff at all levels from 10 Practice-Based Research Networks (PBRNs) serving US patient populations of differing gender, racial, ethnic, urban/rural and socio-economic blends, in the incorporation of a one-page, five-item questionnaire with selective PEF measurement (CAPTURE).

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

LANet, Los Angeles, California, United States

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About this study

This is a prospective, multi-center qualitative study engaging clinical staff at all levels from primary care practices serving US patient populations of differing gender, racial, ethnic, urban/rural and socio-economic blends.

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.

This study will assess, using the RE-AIM approach, how real-word primary care practices might potentially use CAPTURE to: a) identify target populations (Reach); b) appraise optimal targeted respiratory history and symptoms consistent with clinically significant COPD (Effectiveness); c) integrate into practice workflow (Adoption); d) deliver changes and improvements to COPD care within the scope of real-world clinical practice (Implementation); and e) persist in use and quality over time (Maintenance).

Approximately 150 clinicians from 10 participating primary care practices will undergo detailed implementation investigation of the CAPTURE case finding model for clinically significant COPD. In addition, 200 enrolled participants will complete a 10-minute written CAPTURE opinion survey.

Using the RE-AIM framework and consistent phased qualitative analyses, this aim ascertains reach, impact, adoption, implementation and maintenance primary care feasibility recommendation characteristics of CAPTURE via pooled assessment of prescriber clinical staff, non-prescriber clinical staff, CAPTURE-eligible patients and local PBRN clinical quality improvement expertise from 10 primary care practices across 5 US regions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Clinician Participants:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with availability and all study procedures for the duration of the study by the 10 practices (through PBRN recruitment) and their up to 15 clinicians within (through informed consent).
  • Male or female, aged 45 - 80 years

Patient participants [200 participants enrolled in Aim 1 of the CAPTURE Study for an opinion survey]:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged 45 - 80 years.

Exclusion criteria

  • Clinician participants: current employment at practices participating in aims 1 and/or 3
  • Clinician participants: from practices providing fewer than 2 clinician participants
  • Patient participants: meeting the exclusion criteria for aims 1 and 3 (above)

Treatment and study plan

On-site Practice Assessment

Other

The assessment takes place in three parts; the pre-observation practice overview (conducted with the 2 practice clinicians - 60 minutes), the ½ day practice workflow observation (observation by one member of the Aim 2 research team of common and testing areas used for the respiratory patient). There is no patient engagement and no collection of patient-specific identification or health information), and the post-observation practice summary (conducted with the same 2 practice clinicians - 30 minutes).

Clinical Staff Questionnaires

Other

Written or on-line questionnaires are provided to participating and consented staff personnel at two practice levels -- Non-Prescribing clinical (also known as "support") staff and Prescribing (PR) clinical (also known as "provider") staff.

Patient Opinion Surveys

Other

200 Eligible participants will complete a one-time 5 to 10 minute CAPTURE opinion survey.

Modular online COPD Education

Other

Access to free, COPD on-line, continuing education is provided for all clinical staff at each practice. Each module will take 20 minutes or less. Aim 2 clinician participant access and completion of COPD education modules is assessed by clinician questionnaires and focus group item response over 12 months (between months 2 and 14 of Aim 2 timeline).

COPD in Primary Care/CAPTURE Introduction Focus Groups

Other

Two 45 to 60-minute focus group discussions occur at each Aim 2 practice. Focus groups are informed by practice demographics, practice assessment data, as well as patient opinion from CAPTURE surveys and past CAPTURE study. Focus group candidate themes and prompts are developed for non-prescribing clinical staff (NPR) and prescribing clinical staff (PR) and are presented at separate on-site focus group sessions to allow more detailed discussion of role responsibility in the context of daily practice workflow.

Primary outcomes

  1. Primary care clinician perspective on implementing CAPTURE into primary care practice.

    Time frame: Baseline to 2 years

    Primary care clinician perspective on implementing CAPTURE will be assessed using the RE-AIM approach in two focus group sessions consisting of clinical staff self-reporting current clinical practices, the process for implementing a new tool into practice and review of the CAPTURE tool.

Secondary outcomes

  1. Primary care clinician knowledge about respiratory care at the provider level.

    Time frame: Baseline to 2 years

    Primary care clinician knowledge will be assessed using a questionnaire to self report about knowledge and beliefs regard Chronic Obstructive Pulmonary Disease (COPD) and COPD management.

  2. Primary care clinician knowledge about respiratory care at the provider level.

    Time frame: Baseline to 2 years

    Primary care clinician knowledge will be assessed using two focus groups to self report on the staff's knowledge regarding respiratory care.

  3. Primary care clinician attitudes and beliefs regarding respiratory care and communication within their current practice.

    Time frame: Baseline to 2 years

    Primary care clinician attitudes and beliefs will be assessed using a questionnaire to self report respiratory care in their current practice.

  4. Primary care clinician self-efficacy in provider-specific respiratory clinical care.

    Time frame: Baseline to 2 years

    Primary care clinician self-efficacy will be assessed using two focus groups to self report on the staff's perspective regarding self-efficacy of provider-specific respiratory practices.

  5. Primary care clinician attitudes and beliefs about clinical quality improvement and communication within their current practice.

    Time frame: Baseline to 2 years

    Primary care clinician attitudes and beliefs regarding quality improvement and communication within their current practice will be assessed using two focus groups to self report attitude and beliefs.

  6. Existing COPD Clinical care operations within a variety of primary care practices.

    Time frame: Baseline to 2 years

    COPD clinical care operations at various practices will be assessed using two focus groups to self report current COPD clinical care operations within primary care clinicians own practices.

  7. Existing COPD Clinical care operations within a variety of primary care practices.

    Time frame: Baseline to 2 years

    Details of COPD clinical care operations at various practices will be assessed using a questionnaire to self report current COPD clinical care operations within primary care clinicians own practices.

  8. Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.

    Time frame: Baseline to 2 years

    Primary care clinician attitudes and beliefs regarding screening and diagnostic assessment strategies and communication within their current practice will be assessed using two focus groups to self report attitude and beliefs.

  9. Primary care clinician attitudes and beliefs about screening and diagnostic assessment strategies of respiratory care and communication within their current practice.

    Time frame: Baseline to 2 years

    Primary care clinician attitudes and beliefs regarding screening and diagnostic assessment strategies and communication within their current practice will be assessed using a prescriber questionnaire to self report attitude and beliefs.

  10. Patient comprehension of CAPTURE tool instructions and questions.

    Time frame: Baseline to 2 years

    Patient comprehension of CAPTURE tool instructions and questions will be assessed using a CAPTURE opinion survey to self report comprehension.

  11. Patient ease of completion of the CAPTURE tool.

    Time frame: Baseline to 2 years

    Patients' ease of completion of the CAPTURE tool will be assessed using a CAPTURE opinion survey to self report ease of completion.

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
2022
Study completion
2022
First posted
Aug 31, 2018
Registry last updated
Jun 22, 2023

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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