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The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial.

ABSTRACT: Introduction: Innovative methods to increase awareness about clinical trials and address barriers associated with low participation among racial/ethnic minorities are desperately needed. African Americans comprise 5% of all clinical trial participants, and Hispanics make up 1%. Use of multimedia educational material has shown promise as an effective strategy to increase minority clinical trial enrollment. However, this approach has not been broadly implemented. We tested the effect of a video educational program on clinical trial knowledge and enrollment in a sample of oncology outpatients. Methods: A randomized controlled trial was conducted with 63 oncology patients without previous history of clinical trial participation. Participants were randomly assigned to the intervention, to watch a clinical trial educational video in the office, or to the control group which did not receive in-office education. The Clinical Trial Knowledge survey was administered before the intervention and 1 week after the intervention. Participation in clinical trials was assessed 1-year post study participation. Results for white participants and ethnic minorities were compared. Ethnicity was self-reported through the electronic health record and confirmed by self-reporting on questionnaire. Results: Sixty-three participants were recruited in this study. At 1-year follow-up, 3 participants enrolled in clinical trials in the study group which had received office-based video intervention and 2 participants enrolled in the control group (Z = 0.39, p = 0.69). These results were not statistically significant. Impact of the intervention by ethnicity could not be assessed due to low total clinical trial enrollment. The video intervention did not change knowledge, attitudes, or barriers as measured by the Clinical Trial Knowledge Survey. Minority participants did report significantly more negative beliefs and barriers to participation than white participants. Conclusions: Increasing awareness and knowledge about clinical trials in underrepresented communities is an important step to providing opportunities for participation. Future studies should focus on how to address the negative expectations of clinical trials and the greater information needs in minority populations. Tailored or personalized messaging may address negative perceptions of clinical trial participation.

SUBMITTER: Skinner JS

PROVIDER: S-EPMC6498183 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial.

Skinner Jeannine S JS Fair Alecia M AM Holman Alexis S AS Boyer Alaina P AP Wilkins Consuelo H CH

Frontiers in public health 20190426

<b>Introduction:</b> Innovative methods to increase awareness about clinical trials and address barriers associated with low participation among racial/ethnic minorities are desperately needed. African Americans comprise 5% of all clinical trial participants, and Hispanics make up 1%. Use of multimedia educational material has shown promise as an effective strategy to increase minority clinical trial enrollment. However, this approach has not been broadly implemented. We tested the effect of a v ...[more]

PMID: 31106188

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Project description:OBJECTIVE:To evaluate the effectiveness of an educational video explaining aneuploidy testing. METHODS:This was a randomized controlled trial of women with singleton pregnancies having aneuploidy testing at less than 14 weeks of gestation from September 2016 to March 2017 at our prenatal ultrasound center. We developed an educational video on aneuploidy testing. Participants, stratified by age younger than or 35 years or older at estimated delivery date, were randomized to either view or not view the video before their ultrasonogram. Participants 35 years or older also met with a genetic counselor at the ultrasound appointment. All participants completed a survey assessing knowledge of genetic testing (score of 0-15) at baseline and after the appointment. The primary outcome was change in knowledge score after the intervention. A sample size of 23 per group (n=92) was planned for a total of 46 women younger than 35 years of age and 46 women aged 35 years or older. Data are presented as median (interquartile range). RESULTS:Of 104 eligible women who were approached, 92 were randomized. Forty women aged younger than 35 years and 41 women aged 35 years or older completed the study. Baseline characteristics were similar across groups. In women younger than 35 years, the video group had a significant improvement in knowledge score (+2.0 [1.0-5.0]) compared with the control group (0 [-1.0 to 1.0]; P=.01) and reported better understanding of the information compared with the control group (P<.001) with no change in patient satisfaction (P=.25). In women 35 years or older, change in knowledge score was similar for the video and control groups (P=.98) with no difference in self-reported understanding (P=.49) or patient satisfaction (P=.30). CONCLUSION:A patient-centered educational video explaining aneuploidy testing options improved knowledge and self-reported understanding of the information in women younger than 35 years with no change in patient satisfaction. No difference was seen for women 35 years or older, likely as a result of genetic counseling provided to these women.

Project description:To determine whether a behavioral intervention delivered through a video game can improve the appropriateness of trauma triage decisions in the emergency department of non-trauma centers.Randomized clinical trial.Online intervention in national sample of emergency medicine physicians who make triage decisions at US hospitals.368 emergency medicine physicians primarily working at non-trauma centers. A random sample (n=200) of those with primary outcome data was reassessed at six months.Physicians were randomized in a 1:1 ratio to one hour of exposure to an adventure video game (Night Shift) or apps based on traditional didactic education (myATLS and Trauma Life Support MCQ Review), both on iPads. Night Shift was developed to recalibrate the process of using pattern recognition to recognize moderate-severe injuries (representativeness heuristics) through the use of stories to promote behavior change (narrative engagement). Physicians were randomized with a 2×2 factorial design to intervention (game v traditional education apps) and then to the experimental condition under which they completed the outcome assessment tool (low v high cognitive load). Blinding could not be maintained after allocation but group assignment was masked during the analysis phase.Outcomes of a virtual simulation that included 10 cases; in four of these the patients had severe injuries. Participants completed the simulation within four weeks of their intervention. Decisions to admit, discharge, or transfer were measured. The proportion of patients under-triaged (patients with severe injuries not transferred to a trauma center) was calculated then (primary outcome) and again six months later, with a different set of cases (primary outcome of follow-up study). The secondary outcome was effect of cognitive load on under-triage.149 (81%) physicians in the game arm and 148 (80%) in the traditional education arm completed the trial. Of these, 64/100 (64%) and 58/100 (58%), respectively, completed reassessment at six months. The mean age was 40 (SD 8.9), 283 (96%) were trained in emergency medicine, and 207 (70%) were ATLS (advanced trauma life support) certified. Physicians exposed to the game under-triaged fewer severely injured patients than those exposed to didactic education (316/596 (0.53) v 377/592 (0.64), estimated difference 0.11, 95% confidence interval 0.05 to 0.16; P<0.001). Cognitive load did not influence under-triage (161/308 (0.53) v 155/288 (0.54) in the game arm; 197/300 (0.66) v 180/292 (0.62) in the traditional educational apps arm; P=0.66). At six months, physicians exposed to the game remained less likely to under-triage patients (146/256 (0.57) v 172/232 (0.74), estimated difference 0.17, 0.09 to 0.25; P<0.001). No physician reported side effects. The sample might not reflect all emergency medicine physicians, and a small set of cases was used to assess performance.Compared with apps based on traditional didactic education, exposure of physicians to a theoretically grounded video game improved triage decision making in a validated virtual simulation. Though the observed effect was large, the wide confidence intervals include the possibility of a small benefit, and the real world efficacy of this intervention remains uncertain.clinicaltrials.gov; NCT02857348 (initial study)/NCT03138304 (follow-up).

Dataset Information

The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial.

Publications

The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial.

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