Testing Promising Behavioral Economic Interventions to Promote Enrollment Diversity in Cardiovascular Cohort Studies

Summary

Problem. Randomized clinical trials (RCTs) are the best way to determine if interventions are safe and effective. Usually only a small number of eligible patients enroll. This is because trials require people to consent to be enrolled and randomized. Black and Hispanic people are more likely to develop heart disease. They are also more likely to have risk factors for heart disease that are not controlled. Yet they are very under-represented in heart disease trials. This raises concerns about if trial results can be applied to the general population. Trial sponsors are required to enroll patients that reflect the racial and ethnic diversity of real-world people. Black and Hispanic people continue to enroll in trials at a lower rate. The goal of this study is to conduct a series of small randomized trials to test recruitment strategies to increase how many Black and Hispanic people enroll in heart disease clinical trials without diminishing trust. The investigators will test different recruitment strategies for participant enrollment in a few different areas. They will study the method of outreach, the way messages are framed, defaults, and enrollment incentives. They will run smaller recruitment strategy trials within larger parent trials (e.g. Penn Medicine Biobank cohort study). They will run a small recruitment strategy trial to test each approach and then include what they learned in the next small trial.

Conditions

• Cardiovascular Diseases

Interventions

BEHAVIORAL

Method of Contact

Behavioral Intervention studied here is the method of contact (text vs. email vs. email+text).

BEHAVIORAL

Source of Contact

Behavioral Intervention studied here is source of contact (personal clinic vs. research team)

BEHAVIORAL

Framing Method (Appeal to Altruism or Social Proof

Behavioral Intervention studied here is the framing methods "appeal to altruism" and "social proof"

BEHAVIORAL

Incentive Structure

Behavioral Interventions studied here are guaranteed vs. lottery incentives

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of Pennsylvania

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-30

Primary Completion

2024-12-01

Completion

2024-12-01

Countries

• United States

Study Locations