Division of Biomedical Informatics, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Children's Hospital of Philadelphia, Philadelphia.
The Annenberg School for Communication, University of Pennsylvania, Philadelphia.
JAMA Netw Open. 2024 Nov 4;7(11):e2444229. doi: 10.1001/jamanetworkopen.2024.44229.
Marginalized populations have lower levels of clinical trial representation than other populations. Tailoring recruitment materials and providing incentives may improve representation.
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.
A survey regarding the importance of being included in research studies was administered after participants watched a culturally tailored video.
The primary outcome was DTE. Covariates were message effectiveness, clinical trial knowledge, and trust. Intention-to-treat analysis was performed.
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).
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.
ClinicalTrials.gov Identifier: NCT06138145.
边缘人群参与临床试验的比例低于其他人群。调整招募材料并提供激励措施可能会提高代表性。
确定针对特定文化的视频是否能提高家长为孩子（黑人）注册参与研究的意愿。
设计、地点和参与者：这是一项在城市初级保健儿科诊所进行的随机临床试验，采用混合方法和连续抽样。一项事后研究评估了金钱激励与参与意愿的关联。在孩子的预约就诊前，招募了 93 位家长。参与者在完成调查期间被随机分配阅读一段（对照组）、通用视频或定制视频，并收到礼品卡。观看视频的人完成了有关其有效性的问题。所有参与者都被邀请加入登记处。在事后研究中，同意的参与者遵循对照组的方案，协调员承诺他们参与会获得一支钢笔。该研究于 2022 年 11 月 15 日至 2023 年 8 月 29 日进行。
在参与者观看针对特定文化的视频后，会进行关于参与研究重要性的调查。
主要结果是参与意愿。协变量为信息有效性、临床试验知识和信任。采用意向治疗分析。
共纳入 125 人。所有组的家长年龄（总体为 32.6 [7.35] 岁）、性别（110 [88.0%] 为女性）和种族（116 [92.8%] 为黑人或非裔美国人）均相似。在参与意愿方面，有吸引力的视频与对照组（优势比 [OR]，1.19；95%置信区间，0.38-3.72）或通用视频与对照组（OR，1.91；95%置信区间，0.54-6.71）之间没有显著差异。然而，与钢笔激励组相比，所有 3 个礼品卡组的参与意愿更高（例如，对照组与钢笔激励组：OR，5.01；95%置信区间，1.68-14.95）。在调整信任因素后，金钱激励与更高的参与意愿相关（调整后的 OR，5.92；95%置信区间，2.44-14.39）。
在这项随机临床试验中，有针对性的信息传递并没有导致更高的参与儿科临床试验登记的意愿。结合整体信息传递和金钱激励措施可能会提高登记率。
ClinicalTrials.gov 标识符：NCT06138145。
