COPD AsthmaPuSHConNCT03695276
Pulmonary Specialist-Health Coach Consult Model Study
A study testing PushCon Model in people with COPD Asthma, run by University of California, San Francisco at 11 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Asthma
- What is being tested?
- PushCon Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 11 sitesUnited States
- Study dates
- 20 Oct 2020to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish speaking
- At least 18 years of age
- Diagnosed with asthma or COPD
- Experiencing uncontrolled symptoms or exacerbations
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
St. Anthony Medical Clinic
San Francisco, California, 94102
Tom Waddell Urban Health Clinic
San Francisco, California, 94102
Potrero Hill Health Center
San Francisco, California, 94107
Family Health Center
San Francisco, California, 94110
Mission Neighborhood Health Center
San Francisco, California, 94110
Richard H. Fine People's Clinic (General Medicine Clinic)
San Francisco, California, 94110
Maxine Hall Health Center
San Francisco, California, 94115
Ocean Park Health Center
San Francisco, California, 94122
Southeast Health Center
San Francisco, California, 94124
Castro Mission Health Center
San Francisco, California, 94131
Silver Avenue Family Health Center
San Francisco, California, 94134
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- COPD Asthma
- Being tested
- PushCon Model, Usual care
- Keywords
- Health coaching, COPD, Asthma, Access to specialty care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PushCon ModelBehavioural
Also called Pulmonary specialist-health coach consultation 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.
Usual careBehavioural
The standard of care, which usually means management within primary care.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Behavioral: PushCon Model |
| 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Recommended Care
Numerator: Number of guideline-based recommendations implemented by the patient; Denominator: Number of minimal recommendations based on GOLD/GINA guidelines
Measured: 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
Measured: 16 weeks after enrollment
Secondary outcomes (6)
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
Measured: 16 weeks after enrollment
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)
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 16 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start20 Oct 2020
- Primary completion4 Oct 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, with randomization at the individual level
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Rachel Willard-Grace, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695276
- Sponsor's protocol ID
- 1R56HL143366-01
- Other IDs
- R01HL143366
- Acronym
- PuSHCon
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2018
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Willard-Grace R, Cabrera A, Tsao S, Potter MB, Hessler D, Kong M, Thom DH, Hilton JF, Su G. Pulmonary specialist health coach consultation model: a randomized controlled trial. Ann Am Thorac Soc. 2026 Oct 1;23(10):1455-1465. doi: 10.1093/annalsats/aaoag097.
PubMed 42150017
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03695276
- Acronym / sponsor ID
- PuSHCon / 1R56HL143366-01
- Conditions
- COPD Asthma
- Keywords
- Health coaching, COPD, Asthma, Access to specialty care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Posted 14 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial, with randomization at the individual level
| Arm | Type | Receives |
|---|---|---|
| PuSHCon model | Experimental | Behavioral: PushCon ModelA 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, |
| Usual care | Active comparator | Behavioral: Usual carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English or Spanish speaking
- At least 18 years of age
- Diagnosed with asthma or COPD
- Experiencing uncontrolled symptoms or exacerbations
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PushCon ModelAlso: Pulmonary specialist-health coach consultation modelPulmonary 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. | Behavioural | PuSHCon model |
| Usual careThe standard of care, which usually means management within primary care. | Behavioural | Usual care |
Primary outcome
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
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
6 secondary outcomes
Provider Acceptance of Recommended Care
Time frame: 16 weeks after enrollment
Patient-Reported Disease-specific Quality of Life (for Asthma and COPD) - Overall Score
Time frame: 16 weeks after enrollment
Medication Adherence
Time frame: 16 weeks after enrollment
Patient-reported Quality of Care
Time frame: 16 weeks after enrollment
Disease Specific Symptoms Score (COPD & Asthma)
Time frame: 16 weeks after enrollment
Proportion of Patients Who Engaged in Chronic Lung Disease Education
Time frame: 16 weeks after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42150017Willard-Grace R, Cabrera A, Tsao S, Potter MB, Hessler D, Kong M, Thom DH, Hilton JF, Su G. Pulmonary specialist health coach consultation model: a randomized controlled trial. Ann Am Thorac Soc. 2026 Oct 1;23(10):1455-1465. doi: 10.1093/annalsats/aaoag097.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Willard-Grace, MPH principal investigator
University of California, San Francisco
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PushCon Model in people with COPD Asthma, run by University of California, San Francisco at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of Recommended Care (time frame: 16 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.