Palmer Jennifer A, Parker Victoria A, Barre Lacey R, Mor Vincent, Volandes Angelo E, Belanger Emmanuelle, Loomer Lacey, McCreedy Ellen, Mitchell Susan L
Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA.
Hebrew SeniorLife, Hinda & Arthur Marcus Institute for Aging Research, 1200 Centre Street, Roslindale, MA, 02131, USA.
Trials. 2019 Nov 28;20(1):656. doi: 10.1186/s13063-019-3725-5.
The Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is one of the first large pragmatic randomized clinical trials (pRCTs) to be conducted in U.S. nursing homes (N = 119 intervention and N = 241 control across two health-care systems). The trial aims to evaluate the effectiveness of a suite of videos to improve advance care planning (ACP) for nursing home patients. This report uses mixed methods to explore the optimal and suboptimal conditions necessary for implementation fidelity within pRCTs in nursing homes.
PROVEN's protocol required designated facility champions to offer an ACP video to long-stay patients every 6 months during the 18-month implementation period. Champions completed a video status report, stored within electronic medical records, each time a video was offered. Data from the report were used to derive each facility's adherence rate (i.e., cumulative video offer). Qualitative interviews held after 15 months with champions were purposively sampled from facilities within the highest and lowest adherence rates (i.e., those in the top and bottom quintiles). Two researchers analyzed interview data thematically using a deductive approach based upon six domains of the revised Conceptual Framework for Implementation Fidelity (CFIF). Matrices were developed to compare coded narratives by domain across facility adherence status.
In total, 28 interviews involving 33 champions were analyzed. Different patterns were observed across high- versus low-adherence facilities for five CFIF domains. In low-adherence nursing homes, (1) there were limited implementation resources (Context), (2) there was often a perceived negative patient or family responsiveness to the program (Participant Responsiveness), and (3) champions were reticent in offering the videos (Recruitment). In high-adherence nursing homes, (1) there was more perceived patient and family willingness to engage in the program (Participant Responsiveness), (2) champions supplemented the video with ACP conversations (Quality of Delivery), (3) there were strategic approaches to recruitment (Recruitment), and (4) champions appreciated external facilitation (Strategies to Facilitate Implementation).
Critical lessons for implementing pRCTs in nursing homes emerged from this report: (1) flexible fidelity is important (i.e., delivering core elements of an intervention while permitting the adaptation of non-core elements), (2) reciprocal facilitation is vital (i.e., early and ongoing stakeholder engagement in research design and, reciprocally, researchers' and organizational leaders' ongoing support of the implementation), and (3) organizational and champion readiness should be formally assessed early and throughout implementation to facilitate remediation.
ClinicalTrials.gov, NCT02612688. Registered on 19 November 2015.
疗养院视频教育实用试验（PROVEN）是在美国疗养院开展的首批大型实用随机临床试验（pRCT）之一（在两个医疗系统中，119个机构为干预组，241个机构为对照组）。该试验旨在评估一系列视频对改善疗养院患者的预先护理计划（ACP）的有效性。本报告采用混合方法，探讨疗养院pRCT中实现实施保真度所需的最佳和次优条件。
PROVEN方案要求指定的机构负责人在18个月的实施期内，每6个月为长期居住患者提供一次ACP视频。每次提供视频后，负责人要完成一份存储在电子病历中的视频状态报告。报告中的数据用于得出每个机构的依从率（即累计视频提供情况）。在15个月后，从依从率最高和最低的机构（即处于前五分位数和后五分位数的机构）中，有目的地抽取负责人进行定性访谈。两名研究人员基于修订后的实施保真度概念框架（CFIF）的六个领域，采用演绎法对访谈数据进行主题分析。开发了矩阵，以比较不同机构依从状态下各领域的编码叙述。
共分析了涉及33名负责人的28次访谈。在CFIF五个领域中，高依从率和低依从率机构呈现出不同模式。在低依从率的疗养院中，（1）实施资源有限（背景），（2）患者或家属对该项目的反应往往被认为是负面的（参与者反应），（3）负责人在提供视频时有所保留（招募）。在高依从率的疗养院中，（1）患者和家属参与该项目的意愿更强（参与者反应），（2）负责人通过ACP对话补充视频内容（提供质量），（3）有策略性的招募方法（招募），（4）负责人感谢外部促进（促进实施的策略）。
本报告得出了在疗养院实施pRCT的关键经验教训：（1）灵活的保真度很重要（即提供干预的核心要素，同时允许非核心要素进行调整），（2）相互促进至关重要（即利益相关者在研究设计中尽早并持续参与，反过来，研究人员和组织领导者对实施给予持续支持），（3）应在实施早期和整个过程中正式评估组织和负责人的准备情况，以促进补救。
ClinicalTrials.gov，NCT02612688。于2015年11月19日注册。
