A <scp>Provider‐Based</scp> Approach to Address Racial Disparities in Lupus Clinical Trial Participation

Wanty, Nicole; Cooper, Dexter L.; Simkus, Andrew; Twombly, Eric C.; McCalla, Sheryl; Holtz, S Kristen D; Langford, Aisha T.; Cozart, Thometta; Gorlitsky, Barry; Moore, Catherine; Culton, Donna A.; Richardson, Christopher T.; Wardrop, Richard M.; Newcomb, Jeff; Aranow, Cynthia; Lim, S. Sam; Anandarajah, Allen; Sheikh, Saira Z

doi:10.1002/acr.25054

Cited by 5 publications

(2 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Black Americans are far less likely to enroll in research trials than would be expected based on disease prevalence [10]. Although better framing of randomized controlled trials and medical professional training may help [11,12], the distrust of research may be well justified. Recent papers have suggested that Black and White research participants are treated differently within the same trials [13].…”

Section: Research Participationmentioning

confidence: 99%

Steps towards equity in research

Sege

Laraque‐Arena

2023

J. Clin. Trans. Sci.

View full text Add to dashboard Cite

Section: Research Participationmentioning

confidence: 99%

Steps towards equity in research

Sege

Laraque‐Arena

2023

J. Clin. Trans. Sci.

View full text Add to dashboard Cite

“…Data from a recent review propose that the barriers to new treatments in SLE include patient factors, provider factors, and system factors (15). Improving patientprovider communication and shared decision making is likely to result in increased participation in clinical trials (16,17).…”

Section: Introductionmentioning

confidence: 99%

Development of The Lupus Clinical Trials Enrollment Decision Aid: a pilot study

Khalili,

Kukafka,

Weiner

et al. 2024

Front. Lupus

View full text Add to dashboard Cite

IntroductionIn this pilot study, we describe the development of a patient-centered Decision Aid (DA) for participation of SLE clinical trials called “The Lupus Clinical Trials Enrollment DA”.MethodsA draft DA was designed by a development working group using a collaborative, iterative process using the International Patient Decision Aid Standards (IPDAS) guidelines. The approved draft DA was then pilot tested and refined using semi structured interview with 10 lupus providers and 12 SLE patients. Descriptive statistics were calculated. Interviews/surveys were conducted until thematic saturation was achieved. Responses on usefulness were accumulated, and mean usefulness scores were calculated. Feedback from the semi-structured interviews were categorized into several themes as outlined in the results section.ResultsThe definition of treatments, side effects of each option, and expected improvement from each option was outlined. 90% of providers and 91.7% of patients reported that the definition of SOC treatment was clear. Additionally, the expected improvement for SOC (90% of providers, 100% of patients), clinical trial drug (70%, 91.6%), and placebo (70%, 100%) were noted to be clear. Side effects of SOC (80%, 100%), clinical trial drug treatment (80%, 100%), placebo (90%, 100%), were also noted to be clear. 100% of providers and patients thought that the figure outlining pros/cons of participating in clinical trials was appropriate. The mean usefulness scores for the DA were 4.45/5 for providers and 4.67/5 for patients.DiscussionThese data demonstrate that both patients and providers confirm that the newly developed The Lupus Clinical Trials Enrollment DA is useful and easy to use. Qualitative feedback from providers demonstrated concern that aspects of the DA, such as expected improvement and side effects might be unclear to patients; however, patients did not express the same concern in either the quantitative or qualitative feedback.

show abstract

Training to Increase Minority Enrollment in Lupus Clinical Trials With Community Engagement: Enhancing Lupus Clinical Trial Recruitment Through Provider and Community Health Worker Engagement

Sheikh,

Englund,

Simkus

et al. 2024

Arthritis Care & Research

View full text Add to dashboard Cite

ObjectiveThis study evaluates the effectiveness of the Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY) program on enhancing referrals of underrepresented patients to lupus clinical trials. TIMELY leverages two existing American College of Rheumatology online educational initiatives: Materials to Increase Minority Involvement in Clinical Trials (MIMICT), a continuing medical education activity for health care providers, and the community health worker (CHW) Lupus Clinical Trials Training (LuCTT). TIMELY introduced a unique roundtable meeting format to build on the existing online educational programs and facilitate discussions between local clinical trial sites and provider and CHW participants.MethodsThis study used an online pretest and posttest design to assess changes in theory‐based behavioral predictors of lupus clinical trial referrals and engagement (ie, knowledge, attitudes, self‐efficacy, and intentions) among providers and CHWs. Participants completed MIMICT or LuCTT and then were eligible to participate in roundtable meetings. Paired t‐tests were used to assess changes in composite scores before and after the intervention for each of the outcomes.ResultsThe final sample included 40 providers and 18 CHWs. Knowledge scores increased significantly for both providers (P < 0.01) and CHWs (P < 0.001) on completion of MIMICT and LuCTT, respectively. After participating in the TIMELY roundtable, providers’ composite scores for self‐efficacy and intentions significantly increased (P < 0.001). Provider self‐efficacy gains were sustained at three months’ follow‐up (P < 0.001).ConclusionThese promising findings highlight the potential and opportunities for the TIMELY program to improve behavioral predictors of trial referrals, including CHW knowledge and providers’ knowledge, self‐efficacy, and intentions to refer underrepresented patients to lupus clinical trials.

show abstract

A Provider‐Based Approach to Address Racial Disparities in Lupus Clinical Trial Participation

Cited by 5 publications

References 20 publications

Steps towards equity in research

Steps towards equity in research

Development of The Lupus Clinical Trials Enrollment Decision Aid: a pilot study

Training to Increase Minority Enrollment in Lupus Clinical Trials With Community Engagement: Enhancing Lupus Clinical Trial Recruitment Through Provider and Community Health Worker Engagement

Contact Info

Product

Resources

About