Role of health plan administrative claims data in participant recruitment for pragmatic clinical trials: An Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) example
Role of health plan administrative claims data in participant recruitment for pragmatic clinical trials: An Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) example
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DOI：
10.1177/1740774520902989
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发表时间：
2020-02-03
期刊：
影响因子：
2.7
通讯作者：
Haynes, Kevin
中科院分区：
文献类型：
--
作者：
Shi, Qian;Shambhu, Sonali;Haynes, Kevin
目的：本研究的目的是评估HealthCore/国歌研究网络的招聘策略，比较不同的招聘策略的响应和入组率，并描述人口统计学和临床特征的应答者和enrollees.Methods：HealthCore/国歌研究网络，一部分的健康计划研究网络的以患者为中心的临床数据研究网络，使用行政索赔数据，以确定合格的健康计划成员的潜在参与阿司匹林剂量：以患者为中心的试验评估的好处和长期有效性研究。2017年11月至2018年8月期间，我们联系了健康计划成员及其临床提供者，这些成员具有经过验证的以患者为中心的临床数据研究网络通用数据模型可计算表型。提供者可以选择排除他们的患者参与阿司匹林给药：在我们的直接患者（成员）外展之前，以患者为中心的试验评估益处和长期有效性。成员身份识别分为两个阶段：第一阶段：2006年1月1日至2017年4月1日，第二阶段：2006年1月1日至2018年2月2日。第1阶段包括两批邮件和一个电话每名患者。在第二阶段，其中包括两个类似批次的患者，外展是通过邮件或小册子和一个电话。结果：第一阶段和第二阶段包括133,373和51,777名成员，分别。我们在第一阶段聘用了28，593名供应商，在第二阶段聘用了5077名供应商。在第一阶段，我们向133，373名会员发送了264，158封混合电子邮件/邮件信息，随后在2017年11月至2018年2月期间发送了90，481个电话。在第二阶段，在简单随机分组后，从2018年5月到2018年7月，分三波向51，777名成员发送电子邮件/邮件或邮寄小册子。在这9周期间，向电子邮件/邮件组的25 914名成员发送了51 623份信函，向小册子组的25 863名成员发送了50 160份小册子。在电子邮件/邮件或邮寄小册子外展后，分别向这些团体打了16 624个和16 580个电话。截至2018年9月1日，共有1549名健康计划成员访问了研究门户网站; 355人以电子方式签署了知情同意书并入组。邮寄的小册子在第2阶段推动了更多的门户网站访问，但注册的响应者比例较低。2期的招募情况更好-每1000名外展成员招募2.3名入组者，而1期为1.8名。结论：本研究显示了以患者为中心的临床数据研究网络中的健康计划能够识别具有行政索赔的潜在研究参与者，并使用不同的外展方法来促进实际临床试验的招募和入组。
Aim:The purpose of this study is to evaluate HealthCore/Anthem Research Network recruitment strategies, compare response and enrollment rates for different recruitment strategies, and describe demographic and clinical characteristics of responders and enrollees.Methods:HealthCore/Anthem Research Network, a part of the Health Plan Research Network of the Patient-Centered Clinical Data Research Network, used administrative claims data to identify eligible health plan members for potential participation in the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness study. We approached health plan members, identified with a validated Patient-Centered Clinical Data Research Network common data model computable phenotype, and their clinical providers during November 2017 to August 2018. Providers were offered the option to exclude their patients' participation in Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness prior to our direct patient (member) outreach. Member identification was in two phases: Phase 1: 1 January 2006 to 1 April 2017, and Phase 2: 1 January 2006 to 2 February 2018. Phase 1 consisted of two batches of mail and one phone call per patient. In Phase 2, which included two similar batches of patients, outreach was via either mail or brochure and one phone call.Results:Phase 1 and Phase 2 included 133,373 and 51,777 members, respectively. We engaged 28,593 providers in Phase 1, and 5077 in Phase 2. In Phase 1, 264,158 mixed email/mail messages were delivered to 133,373 members, followed by 90,481 phone calls from November 2017 to February 2018. In Phase 2, after simple randomization to letter or brochure, 51,777 members were sent email/mail or mailed brochure in three waves from May 2018 to July 2018. In this 9-week period, 51,623 communications were sent to 25,914 members in the email/mail group, and 50,160 brochures to 25,863 in the brochure group. Following email/mail or mailed brochure outreach, 16,624 and 16,580 calls were made to the groups, respectively. Overall, 1549 health plan members visited the study portal by 1 September 2018; 355 electronically signed the Informed Consent Form and enrolled. Mailed brochures drove more portal visits in Phase 2, but a lower percentage of responders enrolled. Recruitment was better in Phase 2-2.3 enrollees per 1000 outreach members versus 1.8 in Phase 1.Conclusion:This study showed the ability of a health plan within Patient-Centered Clinical Data Research Network to identify potential study participants with administrative claims, and use different outreach methods to facilitate recruitment and enrollment for pragmatic clinical trials.