Pulmonary Specialist-Health Coach Consult Model Pilot

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

February 1, 2019

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Receipt of recommended care[ Time Frame: 3 months after referral ]

Number of specialist recommendations implemented by the patient; Denominator: Number of recommendations made by specialist

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Acceptability[ Time Frame: At least 3 months after model implementation ]
Response of staff and clinicians at pilot site to question, "On a scale of 0 to 10, with 10 being the highest, how likely are you to recommend this model to colleagues?"
Provider acceptance of recommended care[ Time Frame: 3 months after referral ]
Number of specialist recommendations where provider took action; Denominator: Number of recommendations made by specialist

Descriptive Information

Brief Title ^ICMJE

Pulmonary Specialist-Health Coach Consult Model Pilot

Official Title ^ICMJE

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

Brief Summary

The Pulmonary Specialist-Health Coach Consultation (PuSHCon) study examines the implemention 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. A limited number of patients (50) from two clinics will be enrolled in the pilot study; 25 patients from one clinic will receive a pulmonary consultation under usual care and 25 patients from the other clinic 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 is a one-year cluster randomized controlled pilot trial comparing the Pulmonary specialist-health coach (PuSHCon) model to usual care for primary care patients referred for a consultation with a pulmonary specialist. This study is intended to prepare the way for a larger randomized controlled trial comparing the PuSHCon model to usual care for primary care patients referred for a consultation with a pulmonary specialist. The investigators will use a combination of quantitative and qualitative methods to assess the implementation the PuSHCon model and measurement of patient-centered outcomes (Specific Aim 1) and the impact of PuSHCon model on patient reported quality of care, satisfaction, and patient receipt of care recommended by the pulmonary specialist (Specific Aim 2). The results of the current study will provide initial enrollment for a subsequent 5 year randomized controlled trial.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial
Masking: Interventional
Masking Description:Investigators and the Data Safety Monitoring Board will receive data summaries that mask identification of groups.
Primary Purpose: Health Services Research

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: 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.
Behavioral: Usual care
Patients referred for pulmonary consultation will be scheduled for an in-person visit at the central hospital-based office. Recommendations will be provided to the primary care clinician. Implementation of those recommendations will rely on follow up of the primary care clinician.

Study Arms

Experimental: PuSHCon model
A health coach will contact patients referred by their primary care clinician for a pulmonary specialty visit. 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,
Active Comparator: Usual care
Patients referred by their primary care clinician for a pulmonary specialty visit will be scheduled to see a pulmonary specialist, who will send recommendations to the primary care clinician. Implementation of the recommendations will be the responsibility of the primary care clinician.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 30, 2019

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - English or Spanish speaking - At last 18 years of age - Diagnosed with asthma or COPD - Referred to see a pulmonary specialist Exclusion Criteria: - Do not plan to attend primary care clinic for at least 3 months - Cognitive dysfunction that would prevent interaction with a health coach - Not having a phone at which the participant can be reached

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Rachel Willard-Grace, MPH University of California, San Francisco

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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