Pulmonary Specialist-Health Coach Consult Model Study

NCT03695276 | Completed Results DMC

• 2 other identifiers: 1R56HL143366-01R01HL143366
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 11

Brief 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 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.

Conditions

COPD Asthma

Keywords

Health coaching; COPD; Asthma; Access to specialty care

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Provider Acceptance of Recommended Care

  16 weeks after enrollment

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

  16 weeks after enrollment

• Medication Adherence

  16 weeks after enrollment

• Patient-reported Quality of Care

  16 weeks after enrollment

• Disease Specific Symptoms Score (COPD & Asthma)

  16 weeks after enrollment

Study Arms (2)

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,

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.

Behavioral: Usual care

Interventions

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.

Also known as: Pulmonary specialist-health coach consultation model

PuSHCon model

Usual care BEHAVIORAL

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

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (11)

St. Anthony Medical Clinic

San Francisco, California, 94102, United States

Location

Tom Waddell Urban Health Clinic

San Francisco, California, 94102, United States

Location

Potrero Hill Health Center

San Francisco, California, 94107, United States

Location

Family Health Center

San Francisco, California, 94110, United States

Location

Mission Neighborhood Health Center

San Francisco, California, 94110, United States

Location

Richard H. Fine People's Clinic (General Medicine Clinic)

San Francisco, California, 94110, United States

Location

Maxine Hall Health Center

San Francisco, California, 94115, United States

Location

Ocean Park Health Center

San Francisco, California, 94122, United States

Location

Southeast Health Center

San Francisco, California, 94124, United States

Location

Castro Mission Health Center

San Francisco, California, 94131, United States

Location

Silver Avenue Family Health Center

San Francisco, California, 94134, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

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.

Results Point of Contact

• Title: Rachel Willard-Grace
• Organization: UCSF

Rachel.Willard@ucsf.edu

415-476-5248

Study Officials

• Rachel Willard-Grace, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators and the Data Safety Monitoring Board will receive data summaries that mask identification of groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, with randomization at the individual level

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: October 20, 2020
• Primary Completion: October 4, 2024
• Study Completion: January 31, 2025
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)