Pulmonary Specialist-Health Coach Consult Model Study

NCT ID: NCT03695276

Last Updated: 2025-11-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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

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COPD Asthma

Keywords

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Health coaching COPD Asthma Access to specialty care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial, with randomization at the individual level
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
Investigators and the Data Safety Monitoring Board will receive data summaries that mask identification of groups.

Study Groups

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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,

Group Type EXPERIMENTAL

PushCon Model

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Usual care

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Pulmonary specialist-health coach consultation model

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Willard-Grace, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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St. Anthony Medical Clinic

San Francisco, California, United States

Site Status

Tom Waddell Urban Health Clinic

San Francisco, California, United States

Site Status

Potrero Hill Health Center

San Francisco, California, United States

Site Status

Family Health Center

San Francisco, California, United States

Site Status

Mission Neighborhood Health Center

San Francisco, California, United States

Site Status

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

San Francisco, California, United States

Site Status

Maxine Hall Health Center

San Francisco, California, United States

Site Status

Ocean Park Health Center

San Francisco, California, United States

Site Status

Southeast Health Center

San Francisco, California, United States

Site Status

Castro Mission Health Center

San Francisco, California, United States

Site Status

Silver Avenue Family Health Center

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01HL143366

Identifier Type: NIH

Identifier Source: secondary_id

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1R56HL143366-01

Identifier Type: NIH

Identifier Source: org_study_id

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