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

NCT05827718 | Completed

• 1 other identifier: 962643
• Study Type: interventional
• Target: 26,242
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Enrollment fraction of Black + Hispanic patients

  The number of Black and Hispanic patients who enroll in the cohort study, divided by the total number of Black and Hispanic patients attempted to be contacted for consideration of enrollment

  three weeks after all attempts have been made to contact is made

Secondary Outcomes (6)

• Enrollment fraction of Black patients

  three weeks after all attempts have been made to contact is made

• Enrollment fraction of Hispanic patients

  three weeks after all attempts have been made to contact is made

• Enrollment fraction by Area Deprivation Index (ADI) quartile

  three weeks after all attempts have been made to contact is made

• Overall enrollment fraction

  three weeks after all attempts have been made to contact is made

• Participation-to-prevalence ratio (PPR) for Black and Hispanic) patients

  three weeks after all attempts have been made to contact is made

Study Arms (13)

RCT #1, Arm #1: Contact Method, Text Only

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message via text message. This message will invite them to participate in the parent trial.

Behavioral: Method of Contact

RCT #1, Arm #2: Contact Method, Email Only

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message via email. This message will invite them to participate in the parent trial.

Behavioral: Method of Contact

RCT #1, Arm #3: Contact Method, Email+Text

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message via email and text message. This message will invite them to participate in the parent trial.

Behavioral: Method of Contact

RCT #2, Arm #1: Source of Contact, Personal Clinic

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The sender of the message will be the person's personal clinic.

Behavioral: Source of Contact

RCT #2, Arm #2: Source of Contact, Research Team

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The sender of the message will be the research team.

Behavioral: Source of Contact

RCT #3, Arm #1: Framing Method, Appeal to Altruism

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will appeal to the person's altruism, for example: "Research studies like this one often do not include enough Black individuals. If Black people are not included in research like this, then doctors have less information about how cardiovascular disease might affect them and how new treatments could be used to improve their health. Your participation in this research can help doctors better understand how to treat members of your community in the future."

Behavioral: Framing Method (Appeal to Altruism or Social Proof

RCT #3, Arm #2: Framing Method, Social Proof

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will include language about social proof, i.e. information about participation of individuals similar to the person being contacted. For example, the message will include language such as: "Clinical research studies and the development of effective new medications would not have been possible without the participation of thousands of people like you".

Behavioral: Framing Method (Appeal to Altruism or Social Proof

RCT #3, Arm #3: Framing Method, No Appeal to Altruism, No Social Proof

NO INTERVENTION

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will include no language about appeal to altruism or social proof.

RCT #4, Arm #1: Incentive Structure, No Incentive

NO INTERVENTION

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will have no language about incentives.

RCT #4, Arm #2: Incentive Structure, Guarantee Only

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will receive $25.

Behavioral: Incentive Structure

RCT #4, Arm #3: Incentive Structure, Guarantee + Small Lottery

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will receive $15 and have a 1 in 20 chance to receive $200.

Behavioral: Incentive Structure

RCT #4, Arm #4: Incentive Structure, Mid Lottery Only

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will have a 1 in 20 chance to receive $500.

Behavioral: Incentive Structure

RCT #5, Arm #5: Incentive Structure, Large Lottery Only

ACTIVE COMPARATOR

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will have a 1 in 100 chance to receive $2500.

Behavioral: Incentive Structure

Interventions

Method of Contact BEHAVIORAL

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

RCT #1, Arm #1: Contact Method, Text Only; RCT #1, Arm #2: Contact Method, Email Only; RCT #1, Arm #3: Contact Method, Email+Text

Source of Contact BEHAVIORAL

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

RCT #2, Arm #1: Source of Contact, Personal Clinic; RCT #2, Arm #2: Source of Contact, Research Team

Framing Method (Appeal to Altruism or Social Proof BEHAVIORAL

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

RCT #3, Arm #1: Framing Method, Appeal to Altruism; RCT #3, Arm #2: Framing Method, Social Proof

Incentive Structure BEHAVIORAL

Behavioral Interventions studied here are guaranteed vs. lottery incentives

RCT #4, Arm #2: Incentive Structure, Guarantee Only; RCT #4, Arm #3: Incentive Structure, Guarantee + Small Lottery; RCT #4, Arm #4: Incentive Structure, Mid Lottery Only; RCT #5, Arm #5: Incentive Structure, Large Lottery Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must have active medical records in site's electronic medical record system.

You may not qualify if:

• an electronic portal account (e.g. MyPennMedicine)
• have previously been contacted to enroll in the parent trial (e.g. Penn Medicine Biobank)

Sponsors & Collaborators

• University of Pennsylvania: lead
• American Heart Association: collaborator
• Emory University: collaborator

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, investigators, and outcomes assessors will all be blinded to who arm each patient is enrolled into.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT #1: three-arm trial of three methods to contact patients (text v. email v. email+text) / RCT #2: two-arm trial of two sources of contact (personal clinic v. research team) / RCT #3: three-arm trial of framing methods (appeal to altruism vs. appeal to social proof vs. neither) / RCT #4: five-arm trial of incentive structure (no incentive vs. guarantee only vs. guarantee + small lottery vs. mid lottery only vs. large lottery only)

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 25, 2023
• Study Start: October 30, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)