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Promoting Race and Ethnic Diversity in a Hospital-Based Randomized Clinical Trial to Address Untreated Alcohol Use
E Jennifer Edelman1, Tami Frankforter, Oscar F Rojas-Perez
1Department of Internal Medicine, Yale School of Medicine, New Haven, CT (EJE, KA, DP, MBW); Yale Program in Addiction Medicine, Yale School of Medicine, New Haven, CT (EJE, MBW, BDK); Department of Social and Behavioral Sciences, Yale School of Public Health, New Haven, CT (EJE); Yale Center for Clinical Investigation, Yale School of Medicine, New Haven, CT (EJE, CC, IG); Department of Psychiatry, Yale School of Medicine, New Haven, CT (TF, OFR-P, JC, DMG, YJ, CN, MP, BDK); The Consultation Center, New Haven, CT (DMG); Grayken Center for Addiction at Boston Medical Center (NLJ), Boston, MA; Section of General Internal Medicine, Boston University Chobanian and Avedisian School of Medicine, Boston, MA (NLJ); Department of Psychiatry, NYU Langone Health, New York, NY (AJ); Hispanic Clinic, Connecticut Mental Health Center, New Haven, CT (MP); Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, CT (MBW); Department of Health Systems and Population Health, University of Washington School of Public Health, Seattle, WA (ECW); and Health Services Research and Development Seattle-Denver Center of Innovation for Veteran-Centered and Value-Driven Care, Veterans Health Administration, Seattle, WA (ECW).
Recruiting diverse patients with alcohol use disorder (AUD) requires intentional strategies. Multilevel practices in hospital trials can successfully enhance recruitment and retention of racially and ethnically diverse individuals.
Area of Science:
- Clinical Trials
- Health Equity
- Substance Use Disorders
Background:
- Recruiting racially and ethnically diverse patient populations for clinical trials, particularly those with untreated alcohol use disorder (AUD), presents significant challenges.
- Addressing structural racism and social determinants of health is crucial for equitable trial participation.
Purpose of the Study:
- To describe initial experiences and lessons learned from conducting a hospital-based clinical trial focused on recruiting a diverse patient sample with AUD.
- To evaluate the effectiveness of multilevel adaptations in promoting diverse participant recruitment and retention.
Main Methods:
- The study catalogued protocol changes using the Framework for Reporting Adaptations and Modifications-Enhanced.
- Evaluated outcomes using study and electronic medical record data over 18 months.
- Employed multipronged recruitment strategies, including bilingual staff and culturally adapted interventions like Brief Negotiation Interview (BNI) and computer-based cognitive behavioral therapy (CBT4CBT).
Main Results:
- The trial intentionally included individuals impacted by structural racism, utilizing diverse recruitment approaches and staff.
- Intervention adaptations included culturally sensitive BNI scripts, alternative compensation (tablets), and troubleshooting for internet access.
- Setting adaptations involved identifying community AUD treatment options with Spanish-speaking services and resources for social determinants of health.
- Audited data confirmed diverse enrollment: 25% Black, 24% Latine, 58% White, 1% Indigenous, with no observed differences in recruitment or retention by race/ethnicity.
Conclusions:
- Multilevel practices integrated within hospital-based AUD trials can effectively promote the recruitment and retention of racially and ethnically diverse patient samples.
- These findings highlight the importance of tailored, culturally informed strategies to achieve health equity in clinical research.
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