Trial Outcomes & Findings for Pulmonary Specialist-Health Coach Consult Model Study (NCT NCT03695276)

NCT ID: NCT03695276

Last Updated: 2025-11-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 328 participants
• Primary outcome timeframe: 16 weeks after enrollment
• Results posted on: 2025-11-14

Participant Flow

Participant milestones

Measure	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,	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.
Overall Study STARTED	165	163
Overall Study COMPLETED	126	125
Overall Study NOT COMPLETED	39	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

"Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question

Baseline characteristics by cohort

Measure	PuSHCon Model n=165 Participants 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,	Usual Care n=163 Participants 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.	Total n=328 Participants Total of all reporting groups
Age, Continuous	51.9 Years STANDARD_DEVIATION 13.6 • n=10 Participants	53.1 Years STANDARD_DEVIATION 14.0 • n=10 Participants	52.5 Years STANDARD_DEVIATION 13.8 • n=20 Participants
Sex/Gender, Customized Female	118 Participants n=10 Participants • "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question	128 Participants n=10 Participants • "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question	246 Participants n=20 Participants • "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question
Sex/Gender, Customized Male	43 Participants n=10 Participants • "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question	34 Participants n=10 Participants • "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question	77 Participants n=20 Participants • "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question
Sex/Gender, Customized Other	4 Participants n=10 Participants • "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question	1 Participants n=10 Participants • "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question	5 Participants n=20 Participants • "Other" category includes individuals identifying as a gender other than male or female, as well as individuals who preferred not to answer the question
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants
Race (NIH/OMB) Asian	7 Participants n=10 Participants	9 Participants n=10 Participants	16 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=20 Participants
Race (NIH/OMB) Black or African American	60 Participants n=10 Participants	63 Participants n=10 Participants	123 Participants n=20 Participants
Race (NIH/OMB) White	23 Participants n=10 Participants	19 Participants n=10 Participants	42 Participants n=20 Participants
Race (NIH/OMB) More than one race	12 Participants n=10 Participants	6 Participants n=10 Participants	18 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	59 Participants n=10 Participants	63 Participants n=10 Participants	122 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	59 Participants n=10 Participants	56 Participants n=10 Participants	115 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=10 Participants	107 Participants n=10 Participants	213 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Breathing-related quality of life	51.6 Scores on a scale STANDARD_DEVIATION 16.6 • n=10 Participants	52.0 Scores on a scale STANDARD_DEVIATION 16.8 • n=10 Participants	51.8 Scores on a scale STANDARD_DEVIATION 16.7 • n=20 Participants

PRIMARY outcome

Timeframe: 16 weeks after enrollment

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

Outcome measures

Measure	PuSHCon Model n=165 Participants 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,	Usual Care n=163 Participants 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.
Receipt of Recommended Care	38.2 Percentage of guidelines implemented Interval 31.3 to 46.6	23.7 Percentage of guidelines implemented Interval 18.7 to 30.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	PuSHCon Model n=165 Participants 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,	Usual Care n=163 Participants 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.
Receipt of Recommended Medications	126 Participants	110 Participants

SECONDARY outcome

Timeframe: 16 weeks after enrollment

Population: Number of recommendations accepted out of those provided

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

Outcome measures

Measure	PuSHCon Model n=2824 Recommendations 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,	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.
Provider Acceptance of Recommended Care	2425 Recommendations	—

SECONDARY outcome

Timeframe: 16 weeks after enrollment

Population: Includes individuals who completed the 16 week survey

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)

Outcome measures

Measure	PuSHCon Model n=124 Participants 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,	Usual Care n=125 Participants 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.
Patient-Reported Disease-specific Quality of Life (for Asthma and COPD) - Overall Score	37.6 Scores on a scale Standard Deviation 18.6	50.8 Scores on a scale Standard Deviation 18.2

SECONDARY outcome

Timeframe: 16 weeks after enrollment

Population: Includes individuals who completed the 16 week survey and reported taking a controller medication at the time

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

Outcome measures

Measure	PuSHCon Model n=98 Participants 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,	Usual Care n=89 Participants 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.
Medication Adherence	48 Participants	42 Participants

SECONDARY outcome

Timeframe: 16 weeks after enrollment

Population: Includes individuals who completed the 16 week survey

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.

Outcome measures

Measure	PuSHCon Model n=118 Participants 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,	Usual Care n=122 Participants 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.
Patient-reported Quality of Care	3.37 1-5 Likert Scale (5 best) Standard Deviation 1.11	3.12 1-5 Likert Scale (5 best) Standard Deviation 1.12

SECONDARY outcome

Timeframe: 16 weeks after enrollment

Population: Includes individuals who completed a 16 week survey

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)

Outcome measures

Measure	PuSHCon Model n=114 Participants 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,	Usual Care n=122 Participants 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.
Disease Specific Symptoms Score (COPD & Asthma)	40.8 Scores on a scale Standard Deviation 21.1	49.7 Scores on a scale Standard Deviation 21.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	PuSHCon Model n=165 Participants 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,	Usual Care n=163 Participants 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.
Proportion of Patients Who Engaged in Chronic Lung Disease Education	126 Participants	91 Participants

Adverse Events

PuSHCon Model

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Willard-Grace

UCSF

Phone: 415-476-5248

Email: Rachel.Willard@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place