基于移动和网络的伴侣干预以改善远程获取疼痛和创伤后应激障碍症状管理的机会:一项随机对照试验中的招募和流失。
Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial.
机构信息
James A. Haley Veterans' Hospital, Research Service, Tampa, FL, United States.
Division of Epidemiology, Department of Internal Medicine, University of Utah, Salt Lake City, UT, United States.
出版信息
J Med Internet Res. 2023 Oct 3;25:e49678. doi: 10.2196/49678.
BACKGROUND
Increasing access to nonpharmacological interventions to manage pain and posttraumatic stress disorder (PTSD) is essential for veterans. Complementary and integrative health (CIH) interventions can help individuals manage symptom burden with enhanced accessibility via remotely delivered health care. Mission Reconnect (MR) is a partnered, self-directed intervention that remotely teaches CIH skills.
OBJECTIVE
The purpose of this paper is to describe the recruitment, onboarding phase, and attrition of a fully remote randomized controlled trial (RCT) assessing the efficacy of a self-directed mobile and web-based intervention for veterans with comorbid chronic pain and PTSD and their partners.
METHODS
A total of 364 veteran-partner dyads were recruited to participate in a mixed methods multisite waitlist control RCT. Qualitative attrition interviews were conducted with 10 veterans with chronic pain and PTSD, and their self-elected partners (eg, spouse) who consented but did not begin the program.
RESULTS
At the point of completing onboarding and being randomized to the 2 treatment arms, of the 364 recruited dyads, 97 (26.6%) failed to complete onboarding activities. Reported reasons for failure to complete onboarding include loss of self-elected partner buy-in (n=8, 8%), difficulties with using remote data collection methods and interventions (n=30, 31%), and adverse health experiences unrelated to study activities (n=23, 24%). Enrolled veterans presented at baseline with significant PTSD symptom burden and moderate-to-severe pain severity, and represented a geographically and demographically diverse population. Attrition interviews (n=10) indicated that misunderstanding MR including the intent of the intervention or mistaking the surveys as the actual intervention was a reason for not completing the MR registration process. Another barrier to MR registration was that interviewees described the mailed study information and registration packets as too confusing and excessive. Competing personal circumstances including health concerns that required attention interfered with MR registration. Common reasons for attrition following successful MR registration included partner withdrawal, adverse health issues, and technological challenges relating to the MR and electronic data collection platform (Qualtrics). Participant recommendations for reducing attrition included switching to digital forms to reduce participant burden and increasing human interaction throughout the registration and baseline data collection processes.
CONCLUSIONS
Challenges, solutions, and lessons learned for study recruitment and intervention delivery inform best practices of delivering remote self-directed CIH interventions when addressing the unique needs of this medically complex population. Successful recruitment and enrollment of veterans with chronic pain and PTSD, and their partners, to remote CIH programs and research studies requires future examination of demographic and symptom-associated access barriers. Accommodating the unique needs of this medically complex population is essential for improving the effectiveness of CIH programs. Disseminating lessons learned and improving access to remotely delivered research studies and CIH programs is paramount in the post-COVID-19 climate.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772.
背景
增加非药物干预措施以管理疼痛和创伤后应激障碍(PTSD)的途径对于退伍军人至关重要。补充和整合健康(CIH)干预措施可以通过远程提供的医疗保健来帮助个人减轻症状负担。使命连接(MR)是一种合作的、自我指导的干预措施,远程教授 CIH 技能。
目的
本文旨在描述一项完全远程随机对照试验(RCT)的招募、入职阶段和退伍军人慢性疼痛和 PTSD 及其伴侣的自我指导移动和基于网络的干预措施的有效性评估的招募、入职阶段和流失率。
方法
共招募了 364 对有慢性疼痛和 PTSD 的退伍军人-伴侣参与一项混合方法多地点等待对照 RCT。对 10 名患有慢性疼痛和 PTSD 的退伍军人及其自行选择的伴侣(例如配偶)进行了定性流失访谈,这些退伍军人和伴侣同意但未开始该计划。
结果
在完成入职并随机分配到 2 个治疗臂时,在招募的 364 对夫妇中,有 97 对(26.6%)未能完成入职活动。未完成入职活动的原因包括失去自行选择的伴侣的支持(n=8,8%)、使用远程数据收集方法和干预措施存在困难(n=30,31%)以及与研究活动无关的不良健康体验(n=23,24%)。登记的退伍军人在基线时表现出明显的 PTSD 症状负担和中度至重度疼痛严重程度,代表了具有地域和人口统计学差异的人群。流失访谈(n=10)表明,对 MR 的误解,包括干预的意图或误认为调查是实际干预,是未完成 MR 注册过程的原因之一。MR 注册的另一个障碍是受访者表示邮寄的研究信息和注册包过于混乱和复杂。竞争的个人情况,包括需要关注的健康问题,干扰了 MR 注册。MR 注册成功后,退伍军人流失的常见原因包括伴侣退出、健康问题以及与 MR 和电子数据收集平台(Qualtrics)相关的技术挑战。参与者提出的减少流失的建议包括改用数字表格以减轻参与者的负担,并在注册和基线数据收集过程中增加人员互动。
结论
研究招募和干预提供方面的挑战、解决方案和经验教训为远程自我指导 CIH 干预措施的提供提供了最佳实践,以满足这一具有医疗复杂性的人群的独特需求。为远程 CIH 计划和研究招募患有慢性疼痛和 PTSD 的退伍军人及其伴侣,需要进一步研究与人口统计学和症状相关的获取障碍。满足这一具有医疗复杂性的人群的独特需求对于提高 CIH 计划的效果至关重要。传播经验教训和改善远程提供的研究和 CIH 计划的获取对于后 COVID-19 时代至关重要。
试验注册
ClinicalTrials.gov NCT03593772;https://clinicaltrials.gov/ct2/show/NCT03593772。