Re-thinking the Role of Peers And Training Patients [RePeAT]

Not Applicable

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: Peer Coach

• Registration Number: NCT05933655
• Lead Sponsor: University of Rochester

Brief Summary

This study, Re-thinking the role of Peers And Training Patients \[RePeAT\], is designed to test the feasibility of training peer-coaches to prepare limited health literacy (LHL) patients to engage in shared-decision making (SDM) for cardiovascular disease (CVD) risk-reduction.

Detailed Description

The investigators will use a 2-arm pilot RCT design to assess the feasibility, and acceptability of the intervention. Up to 60 primary care patients will be randomly assigned to participate in the peer-coaching or control group. Patients will be randomized at a 1:1 ratio, stratified by the clinician. Half of the subjects (n=30) will be assigned to the peer-coaching intervention, and the other half will be assigned to the control group.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• A patient of Highland Family Medicine practice
• At least 40 years old and no more than 75 years old
• Be at ≥10% risk for CVD as calculated using the ASCVD Risk Estimator Plus
• No plans to leave the practice in the next 12 months
• English speaking
• Limited Health Literacy (self-report)

Exclusion Criteria

• Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA) or have had a CVD procedure such as installation of a stent or angioplasty
• Gave peripheral vascular disease, intermittent claudication or peripheral arterial disease
• Lack of capacity to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Coach	Peer Coach	The research coordinator will set up a time for the subject to have a brief discussion with a peer coach from the study team approximately 1 week after randomization. During the coaching session, the peer coach will encourage the subject to mention their heart health goals to their primary care clinician during their next primary care appointment. The peer coach will also help the subject brainstorm ways to remove any barriers that may prevent them from having the discussion with their clinician. The peer coaching session and the subsequent medical appointment will be audio-recorded.

Primary Outcome Measures

Name	Time	Method
ABCS Discussion	patient-clinician office visit, approximately 1 week after the peer coaching session	The investigators will qualitatively code the office visit to determine if subjects engaged in a discussion with their clinician about their ABCS options/preferences.

Secondary Outcome Measures

Name	Time	Method
Peer Coach Fidelity	post-coaching, approximately 1-2 weeks prior to the patient-clinician office visit	The investigators will qualitatively code the peer coaching sessions to determine if peer coaches used Teach-back during their session and if the coaching session was done with fidelity.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States