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Completed

NCT Number: NCT03695276

Pulmonary Specialist-Health Coach Consult Model Study

The Pulmonary Specialist-Health Coach Consultation (PuSHCon) study examines the implementation of health coach-assisted consultations to improve access to specialist care and implementation of specialist recommendations for patients with COPD, asthma, and asthma COPD overlap syndrome (ACOS) for low-income and vulnerable patients seen at public health clinics. Three hundred sixty (360) patients from ten clinics will be enrolled in the study and randomized at the individual level to receive health coaching or usual care; 180 patients will receive usual care and 180 patients will receive the PuSHCon model.

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Key information

Conditions

COPD Asthma Asthma Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Castro Mission Health Center, San Francisco, California, United States

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About this study

While evidence-based care for chronic obstructive pulmonary disease (COPD) and asthma can substantially reduce disease burden and prevent emergency visits and hospitalizations, it is estimated that 55% of patients with COPD do not receive all recommended care and that less than 50% of patients with asthma are well controlled.

The proposed study will evaluate the effectiveness of a novel model for pulmonary specialist-health coach consultations (PuSHCon) in its ability to increase access to specialty recommendations and the provision of evidence-based care for patients with chronic obstructive pulmonary disease (COPD) and/or asthma receiving care at federally qualified health centers (FQHCs). The specific aims of the study are to compare the use of evidence-based care and of patient reported outcomes 4 months after the consultation. In addition, the study will evaluate the cost per patient in each model to determine the model's effectiveness in increasing access and lowering cost.

The first aim of comparing the use of evidence-based care will be measured as the proportion of guideline-based recommendations that are ultimately received by the patients. The secondary endpoint for this aim will be measured through the proportion of patients receiving guideline-concordant medications at 4 months after consultation compared to baseline.

The second aim of the study regarding patient-reported outcomes will be measured primarily through the change in COPD and/or asthma related quality of life measures from baseline to 4 months post consultation. The secondary measure for this aim will look at changes in COPD and/or asthma specific symptom scores.

The third aim of the study is to assess the impact of this model on access to care and cost of care. Access will be measured by tracking the number of patients who successfully complete a consultation per month. Costs will be determined by calculating time spent per patients, as well as by health care utilization.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • English or Spanish speaking
  • At least 18 years of age
  • Diagnosed with asthma or COPD
  • Experiencing uncontrolled symptoms or exacerbations

Exclusion criteria

  • Do not plan to attend primary care clinic for at least 3 months
  • Already engaged in pulmonary specialty care (defined as at least one visit in last 12 months)
  • Cognitive dysfunction that would prevent interaction with a health coach
  • Not having a phone at which the participant can be reached

Treatment and study plan

PushCon Model

Behavioral

Pulmonary specialist consultation facilitated by a trained health coach, who will gather information from the patient and medical record prior to the consultation and will using health coaching skills to support implementation of recommended care.

Other names: Pulmonary specialist-health coach consultation model

Usual Care

Behavioral

The standard of care, which usually means management within primary care.

Primary outcomes

  1. Receipt of Recommended Care

    Time frame: 16 weeks after enrollment

    Numerator: Number of guideline-based recommendations implemented by the patient; Denominator: Number of minimal recommendations based on GOLD/GINA guidelines

  2. Receipt of Recommended Medications

    Time frame: 16 weeks after enrollment

    Numerator: Number of people receiving all minimal recommended medications based on GOLD/GINA guidelines; Denominator: Number of people enrolled in study

Secondary outcomes

  1. Provider Acceptance of Recommended Care

    Time frame: 16 weeks after enrollment

    Number of guideline-based recommendations where provider took action (e.g., prescribed or referred patient for care); Denominator: Number of minimal recommendations based on GOLD/GINA guidelines

  2. Patient-Reported Disease-specific Quality of Life (for Asthma and COPD) - Overall Score

    Time frame: 16 weeks after enrollment

    Score on St. George's Respiratory questionnaire (overall) with range of 0-100, where 0 is highest quality of life and 100 is lowest. (Full scoring manual located at: http://www.healthstatus.sgul.ac.uk/SGRQ_download/sgrq-c-manual-april-2012.pdf)

  3. Medication Adherence

    Time frame: 16 weeks after enrollment

    Number and percentage of patients taking all controller inhalers as prescribed for at least 5 of the last 7 days

  4. Patient-reported Quality of Care

    Time frame: 16 weeks after enrollment

    Mean score on Patient Assessment of Chronic Illness Care (PACIC) measure, with response options ranging from 1 (Almost never) to 5 (Almost Always). The scale is scored as an overall mean (1-5), with higher scores indicating a more frequent presence of high quality care. Four PACIC subscales (patient activation, delivery system practice design, goal setting/tailoring, problem solving/contextual), plus follow up/coordination are also represented by means of respective items.

  5. Disease Specific Symptoms Score (COPD & Asthma)

    Time frame: 16 weeks after enrollment

    Score on St. George's Respiratory questionnaire (symptom subscale) with range of 0-100, where 0 is highest quality of life and 100 is lowest. (Full scoring manual located at: http://www.healthstatus.sgul.ac.uk/SGRQ_download/sgrq-c-manual-april-2012.pdf)

  6. Proportion of Patients Who Engaged in Chronic Lung Disease Education

    Time frame: 16 weeks after enrollment

    Numerator: Number of people who engage with at least one existing resources such as group education classes or pulmonary care; Denominator: Number of people enrolled in the study

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Pulmonary Specialist-Health Coach Consult (PuSHCon) Model to Improve Access to Specialist Consultation and Receipt of Recommended Evidence-based Care for Vulnerable Patients With Chronic Obstructive Pulmonary Disease (COPD) and Asthma

Acronym: PuSHCon

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Oct 4, 2018
Registry last updated
Nov 14, 2025

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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