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Culturally Tailored Messages and Trial Registry Enrollment: A Randomized Clinical Trial
Kevin B Johnson1,2,3, Stacy L Iannone4, Susan L Furth4,5,6
1Division of Biomedical Informatics, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.
Insights
Culturally tailored videos did not increase parental decisions to enroll Black children in a research registry. Monetary incentives, however, significantly improved enrollment decisions, suggesting a combined approach may be beneficial.
Area of Science:
- Clinical research methodology
- Pediatric health equity
- Health disparities in clinical trials
Background:
- Marginalized populations, including Black children, are underrepresented in clinical trials.
- Effective recruitment strategies are crucial to improve diversity in research.
- Culturally tailored materials and incentives are potential methods to enhance participation.
Purpose of the Study:
- To evaluate the impact of culturally tailored videos on parents' decision to enroll Black children in a research registry.
- To assess the effectiveness of tailored versus generic recruitment messages.
- To determine the influence of monetary incentives on enrollment decisions.
Main Methods:
- A randomized clinical trial was conducted in an urban pediatric clinic.
- Parents were randomized to view a paragraph, generic video, or tailored video.
- A post hoc analysis examined the association between monetary incentives and enrollment decisions.
Main Results:
- No significant difference in enrollment decisions was observed between video groups and the control group.
- Enrollment decisions were significantly higher in groups receiving a monetary incentive (gift card) compared to a non-monetary incentive (ink pen).
- Monetary incentives were associated with higher odds of enrollment, even after adjusting for trust.
Conclusions:
- Culturally tailored video messaging alone did not improve parental decisions to enroll Black children in a research registry.
- Monetary incentives appear to play a significant role in improving enrollment.
- Combining culturally sensitive messaging with monetary incentives may be a promising strategy to enhance pediatric clinical trial participation.
Importance:
Marginalized populations have lower levels of clinical trial representation than other populations. Tailoring recruitment materials and providing incentives may improve representation.
Objective:
To determine whether culturally tailored video improves parents' decision to enroll (DTE) Black children in a research registry.
Design, Setting, And Participants:
A randomized clinical trial, using mixed methods and consecutive sampling, was conducted in an urban primary care pediatric clinic. A post hoc study assessed the association of a monetary incentive with DTE. Ninety-three parents were recruited before their child's scheduled clinic visit. Participants completed a survey during which they were randomly assigned to review a paragraph (control group), generic video, or tailored video and received a gift card. Video watchers completed questions about its effectiveness. All participants were invited to join the registry. In the post hoc study, consenting participants followed the control group protocol and the coordinator promised them an ink pen for participating. The study was conducted between November 15, 2022, and August 29, 2023.
Intervention:
A survey regarding the importance of being included in research studies was administered after participants watched a culturally tailored video.
Main Outcome And Measures:
The primary outcome was DTE. Covariates were message effectiveness, clinical trial knowledge, and trust. Intention-to-treat analysis was performed.
Results:
A total of 125 individuals were included. All groups had similar mean (SD) parent age (overall, 32.6 [7.35] years), gender (110 [88.0%] women), and race (116 [92.8%] Black or African American). There was no significant difference in the odds of DTE between the appeal video and control (odds ratio [OR], 1.19; 95% CI, 0.38-3.72) or between the generic video and control (OR, 1.91; 95% CI, 0.54-6.71). However, DTE was higher for all 3 gift card groups vs the ink pen incentive group (eg, control vs ink pen incentive: OR, 5.01; 95% CI, 1.68-14.95). After adjusting for trust, monetary incentives were associated with higher odds of DTE (adjusted OR, 5.92; 95% CI, 2.44-14.39).
Conclusions And Relevance:
In this randomized clinical trial, targeted messaging was not associated with a higher decision to enroll in a pediatric clinical trial registry. There may be a role for combining holistic messaging with monetary incentives to improve enrollment.
Trial Registration:
ClinicalTrials.gov Identifier: NCT06138145.
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