Evaluating the effectiveness of educational initiatives on recruiting underrepresented participants into SLE clinical trials

BackgroundHealthcare disparities in SLE randomized clinical trials (RCTs) are well known, with minoritized persons being under-represented as trial participants despite facing more significant SLE morbidity and mortality. There is currently limited information as to how to best recruit a diverse group of participants to SLE clinical trials. Barriers to clinical trial participation can originate from either the patients or their clinicians. We therefore sought to investigate the effectiveness of educational curriculum in decreasing such barriers.MethodsWe utilized materials from the American College of Rheumatology, the Lupus Research Alliance, and the Lupus Foundation to develop educational curriculums for both clinicians and patients to see if we could improve their knowledge, attitudes, and skills regarding clinical trial participation.ResultsAttitudes towards clinical trials were highly favorable among patients and clinicians prior to the workshop and remained positive afterwards. The workshops increased the patients' comfort level regarding clinical trial participation, and increased clinician comfort with the clinical trial process and how to refer patients to clinical trials. Regarding knowledge about clinical trials, the results were mixed, with certain knowledge aspects such as the protections afforded to patients in RCTs and SLE disparities improving, but knowledge about the more logistical and regulatory aspects of RCTs not significantly improving. However, these improvements did not translate into increasing patient enrollment into RCTs or research registries.ConclusionAlthough our study did increase both patients' and clinicians' skill and comfort level regarding RCT participation, its small size did not allow us to observe concrete gains in RCT enrollment.

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Publication Details

Journal
Lupus
Published
2025-12-22
DOI
https://doi.org/10.1177/09612033251410419
Primary Topic
Mental Health and Patient Involvement
Type
article
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article

Evaluating the effectiveness of educational initiatives on recruiting underrepresented participants into SLE clinical trials

Shivani Kottur, Maria A. Bacalao, David Karp, Marie Maitre
Lupus
Mental Health and Patient Involvement
article

Evaluating the effectiveness of educational initiatives on recruiting underrepresented participants into SLE clinical trials

Shivani Kottur, Maria A. Bacalao, David Karp, Marie Maitre
article en

Abstract

BackgroundHealthcare disparities in SLE randomized clinical trials (RCTs) are well known, with minoritized persons being under-represented as trial participants despite facing more significant SLE morbidity and mortality. There is currently limited information as to how to best recruit a diverse group of participants to SLE clinical trials. Barriers to clinical trial participation can originate from either the patients or their clinicians. We therefore sought to investigate the effectiveness of educational curriculum in decreasing such barriers.MethodsWe utilized materials from the American College of Rheumatology, the Lupus Research Alliance, and the Lupus Foundation to develop educational curriculums for both clinicians and patients to see if we could improve their knowledge, attitudes, and skills regarding clinical trial participation.ResultsAttitudes towards clinical trials were highly favorable among patients and clinicians prior to the workshop and remained positive afterwards. The workshops increased the patients' comfort level regarding clinical trial participation, and increased clinician comfort with the clinical trial process and how to refer patients to clinical trials. Regarding knowledge about clinical trials, the results were mixed, with certain knowledge aspects such as the protections afforded to patients in RCTs and SLE disparities improving, but knowledge about the more logistical and regulatory aspects of RCTs not significantly improving. However, these improvements did not translate into increasing patient enrollment into RCTs or research registries.ConclusionAlthough our study did increase both patients' and clinicians' skill and comfort level regarding RCT participation, its small size did not allow us to observe concrete gains in RCT enrollment.

LupusVol. 35(2)
Parkland Health & Hospital System (US), The University of Texas Southwestern Medical Center (US)
Openalex Percentile: Top 24%
Mental Health and Patient Involvement
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