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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Peer Coach

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Peer Coach; Peer coaching session to support shared decision making among patient with limited health literacy.
No Intervention: Control; The subject will not be asked to meet with the peer coach or anyone from the study team prior to their next visit with their primary care clinician. Their subsequent primary care appointment will be audio-recorded.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peer Coach Fidelity	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.	post-coaching, approximately 1-2 weeks prior to the patient-clinician office visit

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): January 31, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 18638; K01HL159046 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No