Bloomberg School of Public Health, Johns Hopkins University, Hampton House, Room 663, 624 N Broadway, Baltimore, MD, 21205, USA.
Department of Surgery, McMaster University, Hamilton, ON, Canada.
Trials. 2019 Jul 19;20(1):447. doi: 10.1186/s13063-019-3536-8.
The Venous Thromboembolism Prophylaxis (VTE-PRO) randomized trial is a pilot study evaluating the impact of extended-duration prophylaxis on venous thromboembolic events in patients undergoing lung cancer resection. Enrolled VTE-PRO participants self-inject either low-molecular weight heparin or a saline placebo for 30 days postoperatively. Study outcomes include feasibility, incidence of venous thromboembolism, and venous thromboembolism-related morbidity and mortality. Initial analyses demonstrated low rates of accrual and retention for the VTE-PRO pilot. Therefore, the purpose of the current study was to develop a knowledge translation intervention to improve VTE-PRO pilot trial accrual and retention.
Eligible participants were surveyed to identify the barriers to VTE-PRO participation. The Theoretical Domains Framework was used to categorize these barriers. Barriers were mapped to the capabilities, opportunities, and behavior (COM-B) behavioral change wheel to identify potential interventions to support trial accrual and retention. The resulting knowledge translation intervention was titled Inform, Remind, Involve and Support to improve Accrual and Retention (IRIS-AR). Key informant interviews with patients were held to refine and confirm the validity of identified barriers and perceived acceptability of the proposed IRIS-AR intervention. Institutional Review Board approval was granted for this study.
The resulting intervention included: information booklets and counseling sessions to identify unique participant challenges to trial participation (Inform); daily reminders to administer injections (Remind); involvement of family/caregivers in study processes (Involve); and leverage of an existing home-care nursing program to provide injection support when needed (Support). Twenty-six key informant participants were interviewed. The most common barriers to trial participation included lack of social support and fear of needle injection. Participants generally supported use of information booklets, involvement of family/caregivers, and support by a home-care nursing program; however, not all supported the use of daily reminders.
Developed using theory and integrated knowledge translation, the IRIS-AR presents a patient-centered intervention that leverages existing programs to promote trial engagement. The proposed strategy can likely be adapted to improve compliance with other patient-directed interventions.
ClinicalTrials.gov, NCT02334007 . Registered on 8 January 2015.
静脉血栓栓塞症预防（VTE-PRO）随机试验是一项试点研究，评估肺癌切除术后延长抗凝时间对静脉血栓栓塞事件的影响。入组的 VTE-PRO 参与者在术后 30 天内自行注射低分子肝素或生理盐水安慰剂。研究结果包括可行性、静脉血栓栓塞事件发生率以及静脉血栓栓塞症相关发病率和死亡率。最初的分析显示，VTE-PRO 试验的入组率和保留率较低。因此，本研究的目的是开发一种知识转化干预措施，以提高 VTE-PRO 试验的入组率和保留率。
对符合条件的参与者进行调查，以确定参与 VTE-PRO 试验的障碍。使用理论领域框架对这些障碍进行分类。将这些障碍映射到能力、机会和行为（COM-B）行为改变轮，以确定支持试验入组和保留的潜在干预措施。由此产生的知识转化干预措施命名为“提高入组和保留率的信息、提醒、参与和支持（IRIS-AR）”。对患者进行了关键知情人访谈，以完善和确认确定的障碍的有效性和对拟议的 IRIS-AR 干预措施的可接受性。本研究获得了机构审查委员会的批准。
干预措施包括：信息手册和咨询，以确定参与试验的独特参与者挑战（信息）；每天提醒注射（提醒）；让家属/照顾者参与研究过程（参与）；并利用现有的家庭护理护士计划在需要时提供注射支持（支持）。对 26 名关键知情人进行了访谈。参与试验的最大障碍包括缺乏社会支持和对针头注射的恐惧。参与者普遍支持使用信息手册、让家属/照顾者参与以及利用家庭护理护士计划；然而，并非所有人都支持使用每日提醒。
使用理论和综合知识转化开发的 IRIS-AR 提出了一种以患者为中心的干预措施，利用现有的计划来促进试验参与。所提出的策略很可能适用于提高其他以患者为导向的干预措施的依从性。
ClinicalTrials.gov，NCT02334007。注册于 2015 年 1 月 8 日。
