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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL143366 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PuSHCon model | Experimental | A health coach will contact patients with poorly controlled asthma or COPD. The health coach will gather information from the patient and medical record and review the case with a pulmonary specialist. The specialist will provide recommendations to the primary care clinician based on the case review; the specialist may request an in-person patient visit if needed. The health coach will follow up with the primary care clinician and will support implementation of recommendations that the the primary care clinician accepts, |
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| Usual care | Active Comparator | Patients with poorly controlled asthma or COPD will receive the standard of care, which usually means management within primary care. The study team will provide in-service sessions on COPD and asthma guidelines to primary care clinicians in both arms. As in standard practice, a primary care clinician may refer a patient for specialty consultation or diagnostic testing at any time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of Recommended Care | Numerator: Number of guideline-based recommendations implemented by the patient; Denominator: Number of minimal recommendations based on GOLD/GINA guidelines | 16 weeks after enrollment |
| Receipt of Recommended Medications | Numerator: Number of people receiving all minimal recommended medications based on GOLD/GINA guidelines; Denominator: Number of people enrolled in study | 16 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Provider Acceptance of Recommended Care | 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 | 16 weeks after enrollment |
| Patient-Reported Disease-specific Quality of Life (for Asthma and COPD) - Overall Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Willard-Grace, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Anthony Medical Clinic | San Francisco | California | 94102 | United States | ||
| Tom Waddell Urban Health Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | PuSHCon Model | A health coach will contact patients with poorly controlled asthma or COPD. The health coach will gather information from the patient and medical record and review the case with a pulmonary specialist. The specialist will provide recommendations to the primary care clinician based on the case review; the specialist may request an in-person patient visit if needed. The health coach will follow up with the primary care clinician and will support implementation of recommendations that the the primary care clinician accepts, |
| FG001 | Usual Care | Patients with poorly controlled asthma or COPD will receive the standard of care, which usually means management within primary care. The study team will provide in-service sessions on COPD and asthma guidelines to primary care clinicians in both arms. As in standard practice, a primary care clinician may refer a patient for specialty consultation or diagnostic testing at any time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PuSHCon Model | A health coach will contact patients with poorly controlled asthma or COPD. The health coach will gather information from the patient and medical record and review the case with a pulmonary specialist. The specialist will provide recommendations to the primary care clinician based on the case review; the specialist may request an in-person patient visit if needed. The health coach will follow up with the primary care clinician and will support implementation of recommendations that the the primary care clinician accepts, |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Receipt of Recommended Care | Numerator: Number of guideline-based recommendations implemented by the patient; Denominator: Number of minimal recommendations based on GOLD/GINA guidelines | Posted | Mean | 95% Confidence Interval | Percentage of guidelines implemented | 16 weeks after enrollment |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PuSHCon Model | A health coach will contact patients with poorly controlled asthma or COPD. The health coach will gather information from the patient and medical record and review the case with a pulmonary specialist. The specialist will provide recommendations to the primary care clinician based on the case review; the specialist may request an in-person patient visit if needed. The health coach will follow up with the primary care clinician and will support implementation of recommendations that the the primary care clinician accepts, PushCon Model: 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. |
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The PuSHCon study randomized participants at the individual rather than the clinician or practice level.
This study was carried out in safety net practices within a single city and over a short duration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Willard-Grace | UCSF | 415-476-5248 | Rachel.Willard@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2025 | Oct 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 7, 2023 | Oct 2, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Randomized controlled trial, with randomization at the individual level
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Investigators and the Data Safety Monitoring Board will receive data summaries that mask identification of groups.
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| Usual care | Behavioral | The standard of care, which usually means management within primary care. |
|
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) |
| 16 weeks after enrollment |
| Medication Adherence | Number and percentage of patients taking all controller inhalers as prescribed for at least 5 of the last 7 days | 16 weeks after enrollment |
| Patient-reported Quality of Care | 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. | 16 weeks after enrollment |
| Disease Specific Symptoms Score (COPD & Asthma) | 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) | 16 weeks after enrollment |
| Proportion of Patients Who Engaged in Chronic Lung Disease Education | 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 | 16 weeks after enrollment |
| San Francisco |
| California |
| 94102 |
| United States |
| Potrero Hill Health Center | San Francisco | California | 94107 | United States |
| Family Health Center | San Francisco | California | 94110 | United States |
| Mission Neighborhood Health Center | San Francisco | California | 94110 | United States |
| Richard H. Fine People's Clinic (General Medicine Clinic) | San Francisco | California | 94110 | United States |
| Maxine Hall Health Center | San Francisco | California | 94115 | United States |
| Ocean Park Health Center | San Francisco | California | 94122 | United States |
| Southeast Health Center | San Francisco | California | 94124 | United States |
| Castro Mission Health Center | San Francisco | California | 94131 | United States |
| Silver Avenue Family Health Center | San Francisco | California | 94134 | United States |
| BG001 | Usual Care | Patients with poorly controlled asthma or COPD will receive the standard of care, which usually means management within primary care. The study team will provide in-service sessions on COPD and asthma guidelines to primary care clinicians in both arms. As in standard practice, a primary care clinician may refer a patient for specialty consultation or diagnostic testing at any time. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Breathing-related quality of life | St. George Respiratory Questionnaire Score (0-100, where 0 is best) | Mean | Standard Deviation | Scores on a scale |
|
| Usual Care |
Patients with poorly controlled asthma or COPD will receive the standard of care, which usually means management within primary care. The study team will provide in-service sessions on COPD and asthma guidelines to primary care clinicians in both arms. As in standard practice, a primary care clinician may refer a patient for specialty consultation or diagnostic testing at any time. |
|
|
| Primary | Receipt of Recommended Medications | Numerator: Number of people receiving all minimal recommended medications based on GOLD/GINA guidelines; Denominator: Number of people enrolled in study | Posted | Count of Participants | Participants | 16 weeks after enrollment |
|
|
|
| Secondary | Provider Acceptance of Recommended Care | 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 | Number of recommendations accepted out of those provided | Posted | Count of Units | Recommendations | 16 weeks after enrollment | Recommendations | Recommendations |
|
|
|
| Secondary | Patient-Reported Disease-specific Quality of Life (for Asthma and COPD) - Overall Score | 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) | Includes individuals who completed the 16 week survey | Posted | Mean | Standard Deviation | Scores on a scale | 16 weeks after enrollment |
|
|
|
| Secondary | Medication Adherence | Number and percentage of patients taking all controller inhalers as prescribed for at least 5 of the last 7 days | Includes individuals who completed the 16 week survey and reported taking a controller medication at the time | Posted | Count of Participants | Participants | 16 weeks after enrollment |
|
|
|
| Secondary | Patient-reported Quality of Care | 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. | Includes individuals who completed the 16 week survey | Posted | Mean | Standard Deviation | 1-5 Likert Scale (5 best) | 16 weeks after enrollment |
|
|
|
| Secondary | Disease Specific Symptoms Score (COPD & Asthma) | 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) | Includes individuals who completed a 16 week survey | Posted | Mean | Standard Deviation | Scores on a scale | 16 weeks after enrollment |
|
|
|
| Secondary | Proportion of Patients Who Engaged in Chronic Lung Disease Education | 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 | Posted | Count of Participants | Participants | 16 weeks after enrollment |
|
|
|
| 0 |
| 165 |
| 0 |
| 165 |
| 0 |
| 165 |
| EG001 | Usual Care | Patients with poorly controlled asthma or COPD will receive the standard of care, which usually means management within primary care. The study team will provide in-service sessions on COPD and asthma guidelines to primary care clinicians in both arms. As in standard practice, a primary care clinician may refer a patient for specialty consultation or diagnostic testing at any time. Usual care: The standard of care, which usually means management within primary care. | 0 | 163 | 0 | 163 | 0 | 163 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |