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.
BMC Health Serv Res. 2019 Jul 29;19(1):527. doi: 10.1186/s12913-019-4309-5.
The PRagmatic trial Of Video Education in Nursing homes (PROVEN) aims to test the effectiveness of an advance care planning (ACP) video intervention. Relatively little is known about the challenges associated with implementing ACP interventions in the nursing home (NH) setting, especially within a pragmatic trial. To address this research gap, this report sought to identify facilitators of and barriers to implementing PROVEN from the perspective of the Champions charged with introducing the ACP video program delivery to patients and families.
In semi-structured telephone interviews at 4 and 15 months of the 18-month implementation period, ACP Champions at all PROVEN intervention facilities (N = 119) were asked about their perceptions of program implementation. Forty interviews were purposively sampled, transcribed, and analyzed using a hybrid deductive/inductive approach to thematic analysis incorporating the Consolidated Framework for Implementation Research's domains: Intervention Characteristics (IC), Inner Setting (IS), Characteristics of Individuals (CI), Outer Setting (OS), and Process (P).
Implementation facilitators identified by Champions included: the intervention's adaptable mode of presentation and minimal time burden (IC) as well as the program's customizable delivery to patients and families and opportunity for group reflection on implementation among ACP Champions (P). Barriers included mandated protocol-driven aspects of the program (OS), limited time to deliver the intervention (IS), and lack of perceived relevance and emotional readiness for ACP amongst stakeholders (CI).
Despite the promise of PROVEN's intervention for improving ACP in nursing homes, unchangeable setting and characteristics of Champions, patients, and family members presented implementation barriers. Researchers need to engage all program participants (i.e., facility staff, patients, and families), in addition to corporate-level stakeholders, in early pragmatic trial design to minimize such obstacles. Further, despite the facilitating nature of PROVEN's implementation processes, the study encountered tension between scientific rigor and real-world demands. Researchers need to optimize the real-world authenticity of pragmatic trial design while avoiding excessive implementation protocol deviations.
ClinicalTrials.gov Identifier: NCT02612688. Registered 19 November 2015.
养老院中视频教育的实用临床试验(PROVEN)旨在测试预先护理计划(ACP)视频干预的有效性。在养老院(NH)环境中实施 ACP 干预措施相关的挑战相对较少,特别是在实用临床试验中。为了解决这一研究空白,本报告试图从负责向患者及其家属推出 ACP 视频方案的“拥护者”的角度,确定实施 PROVEN 的促进因素和障碍。
在实施期的第 4 个月和第 15 个月进行了 18 个月的半结构电话访谈,PROVEN 干预设施的所有 ACP 拥护者(N=119)都被问及他们对项目实施的看法。有 40 次访谈是有目的抽样的,转录后采用综合实施研究框架的领域的演绎/归纳混合方法进行主题分析:干预特征(IC)、内部环境(IS)、个体特征(CI)、外部环境(OS)和过程(P)。
拥护者确定的实施促进因素包括:干预的适应性呈现模式和最小的时间负担(IC),以及该方案对患者及其家属的可定制交付以及 ACP 拥护者对实施进行小组反思的机会(P)。障碍包括方案的强制性协议驱动方面(OS)、交付干预措施的时间有限(IS)以及利益相关者对 ACP 的感知相关性和情感准备不足(CI)。
尽管 PROVEN 的干预措施有改善 NH 中 ACP 的前景,但不可改变的设置和拥护者、患者和家属的特征提出了实施障碍。研究人员需要让所有的项目参与者(即,医疗机构工作人员、患者和家属)以及公司层面的利益相关者参与到早期实用临床试验设计中,以尽量减少这些障碍。此外,尽管 PROVEN 的实施过程具有促进作用,但研究中出现了科学严谨性与现实需求之间的紧张关系。研究人员需要在避免过度实施协议偏离的情况下,优化实用临床试验设计的现实真实性。
ClinicalTrials.gov 标识符:NCT02612688。注册于 2015 年 11 月 19 日。