Behavioral Economics to Transform Trial Enrollment Representativeness (BETTER)

Randomized clinical trials (RCTs) are the best way to determine if interventions are safe and effective. However, most RCTs fail to enroll and retain diverse patients. This means that research participants are not representative of the groups of patients that have the disease that is being studied.

Behavioral economics (BE) tell us how people make decisions. We have used BE to understand health behaviors. To date, there has not been sufficient research on how BE could improve enrollment and retention of representative patients in RCTs. The goal of the BETTER Center is to develop and test BE methods that may address the problem described above.

As part of the BETTER Center, we are conducting three projects.

Project 1 LEARN

Learning about enrollment and recruitment of underrepresented groups

QUESTION: What are the barriers and facilitators to research study participation for historically underrepresented groups, namely women, people residing in rural areas, and people who identify as Black or Hispanic/Latino?

AIMS 1 & 2: We conducted a systematic review of adult cardiovascular trials (2,304 articles for Aim 1; 92 articles for Aim 2) to better understand the reporting of ethnicity, race, and gender-specific population in clinical trials.

AIM 3: We conducted a survey (n=103), using freelisting and open-ended questions, to elicit barriers and facilitators to participation in research studies. We also conducted a discrete choice experiment (DCE) (n=257) to determine patient’s preferences for different recruitment and engagement strategies. Finally, we conducted focus groups (n=21, across 8 focus groups) with patients to gain a deeper understanding of all factors that may affect potential study participants’ decision making.

Project 2 ITERATE

Increasing trial equity and representativeness by rapid cycle testing of nudges

QUESTION: What BE methods improve the racial and ethnic diversity of people in prospective studies?

AIM: Our goal was to conduct a series of 4 RCTs to test behavioral economic strategies to increase how many Black and Hispanic people enroll in studies. We specifically conducted these trials within the context of patient enrollment in the Penn Medicine BioBank (PMBB). RCT 1 tested the method of outreach (email vs. text message vs. email + text message); RCT 2, source of outreach (research team vs. clinical team); RCT 3, message framing (appeal to altruism vs. appeal to social proof vs. control); and RCT 4, financial incentive (none vs. medium guarantee vs. small guarantee + small lottery vs. medium lottery vs. large lottery) (Patel et al., 2025).

Project 3 OSPREY

Optimizing strategies for patient recruitment yield

QUESTION: When using MyChart messages for recruitment, what are the BE methods that improve the representativeness of clinical research studies?

AIM: Our goal is to conduct a platform trial with the Georgia CTSA MyChart recruitment center to assess the impact of novel recruitment methods on the representativeness of the patient population enrolled in research studies, as well as the ethical impacts of these methods (patient understanding, undue inducement, and trust). We will conduct this trial by reviewing the recruitment messages for each parent study, transforming them into four messages that test the effects of disclosing information about study payments and positively-framed language (in collaboration with the parent study teams and stakeholders), and then implementing them in the MyChart recruitment system.

The goal of the BETTER Center is to inform the design of RCTs so that they enroll participants who accurately represent the population to whom the trial results would be applied. Specifically, the BETTER Center Projects focus on how to make RCTs more representative of people who have heart disease or who are at risk of developing heart disease.

Project 1 LEARN

In Aims 1 & 2, we demonstrated that 86% of trials across disease processes under-represented Black, Hispanic or Latinx, and women patients, with only 3 groups appropriately represented (Kohn et al., 2024).

In Aim 3, we identified key barriers and facilitators to research participation for underrepresented groups, and patients’ preferred strategies for enrolling in trials. Manuscripts summarizing the findings are forthcoming.

Project 2 ITERATE

In each of the four RCTs, we identified patients eligible for enrollment in the PMBB and randomly assigned them to receive different outreach messages. The primary outcome of each RCT was enrollment fraction, defined as the number of participants who enrolled in the PMBB divided by the total number of participants who received an outreach message, compared between arms among both Black and Hispanic patients. A manuscript summarizing the findings is forthcoming.

Project 3 OSPREY

Project 3 OSPREY is ongoing. We are currently partnering with 14 parent studies through the Georgia CTSA to send approximately 200 recruitment messages per week per study. We anticipate that this project will be completed by the end of 2026.