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

NCT05933655 | Active Not Recruiting

• 2 other identifiers: 18638K01HL159046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Peer Coach Fidelity

  post-coaching, approximately 1-2 weeks prior to the patient-clinician office visit

Study Arms (2)

Peer Coach

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Peer Coach BEHAVIORAL

Peer coaching session to support shared decision making among patient with limited health literacy.

Peer Coach

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Immediately after subjects complete the baseline surveys they will be randomized. The research coordinator will open a sealed envelope that specifies which group the subject is in. Neither the subject nor the research coordinator can choose the randomization group. The randomizations envelopes will be prepared
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: . Patients will be randomized at a 1:1 ratio, stratified by the clinician.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 6, 2023
• Study Start: September 1, 2021
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)