Palmer Jennifer A, Mor Vincent, Volandes Angelo E, McCreedy Ellen, Loomer Lacey, Carter Phoebe, Dvorchak Faye, Mitchell Susan L
Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA.
Hebrew SeniorLife, Institute for Aging Research, 1200 Centre Street, Roslindale, MA, 02131, USA.
Trials. 2018 Aug 22;19(1):453. doi: 10.1186/s13063-018-2817-y.
PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) can assess how clinical trial design decisions (along the explanatory-pragmatic continuum) influence the applicability of trial results to intended stakeholders. The tool has been used to assess features of trials during the trial design phase and also upon completion. The ongoing PRagmatic trial Of Video Education in Nursing homes (PROVEN), which is evaluating the effectiveness of a suite of videos to improve advance care planning, is one of the first large pragmatic, cluster randomized trials within nursing home health care systems. While certain features of pragmatic trials remain static once designed (e.g., recruitment, outcomes), successful implementation of a system-wide program requires on-going evaluation and adaptation. This report's objectives were to apply PRECIS-2 in a novel manner during the actual conduct of the PROVEN trial to assess how dynamic adaptations shifted implementation to either a more explanatory or a more pragmatic approach.
We assessed PROVEN's protocol as initially designed according to the three PRECIS-2 domains pertinent to implementation: (1) Organization, (2) Flexibility-Delivery, and (3) Flexibility-Adherence. We then applied this framework to conduct a formative evaluation of decisions made while the trial was ongoing to adapt the implementation approach along the pragmatic versus the explanatory continuum in response to emergent challenges.
Based on the PRECIS-2 rubric, the initial design of the PROVEN implementation approach reflected a hybrid of pragmatic and explanatory features. Most notably, within the Flexibility-Delivery, the trial had a relatively pragmatic approach to protocol delivery by front-line nursing home providers, balanced with a more explanatory approach to protocol monitoring enabled by the analytic capabilities of the research team. This more intensive monitoring proved critical in revealing implementation problems once the study began. Dynamic adaptations made in response to these challenges generally reflected shifts to more explanatory approaches within the Flexibility-Delivery and Flexibility-Adherence domains including ever more intensive compliance monitoring, as well as detailed coaching of front-line providers delivering the intervention by the research team.
Pragmatic trials conducted in the nursing home setting may benefit from a more dynamic approach to implementation. Allowing fluidity between pragmatic and explanatory features may still preserve the trial's applicability to intended stakeholders' needs. PRECIS-2 provides a useful formative evaluation tool to assess these adaptations in "real-time."
US National Library of Medicine, ClinicalTrials.gov, ID: NCT02612688 . Registered on 19 November 2015.
PRECIS-2（实用-解释性连续体指标总结-2）可以评估临床试验设计决策（沿着解释性-实用性连续体）如何影响试验结果对目标利益相关者的适用性。该工具已用于在试验设计阶段以及完成后评估试验的特征。正在进行的养老院视频教育实用试验（PROVEN）正在评估一系列视频对改善预先护理计划的有效性，这是养老院医疗保健系统内首批大型实用、整群随机试验之一。虽然实用试验的某些特征一旦设计完成就保持不变（例如，招募、结果），但全系统项目的成功实施需要持续的评估和调整。本报告的目的是以一种新颖的方式在PROVEN试验的实际实施过程中应用PRECIS-2，以评估动态调整如何将实施转向更具解释性或更具实用性的方法。
我们根据与实施相关的三个PRECIS-2领域评估了PROVEN最初设计的方案：（1）组织，（2）灵活性-实施，以及（3）灵活性-依从性。然后，我们应用这个框架对试验进行过程中为应对新出现的挑战而沿着实用性与解释性连续体调整实施方法所做出的决策进行形成性评估。
根据PRECIS-2评分标准，PROVEN实施方法的初始设计体现了实用性和解释性特征的混合。最值得注意的是，在灵活性-实施方面，该试验对于一线养老院提供者实施方案采取了相对实用的方法，同时通过研究团队的分析能力对方案监测采取了更具解释性的方法。一旦研究开始，这种更密集的监测对于发现实施问题至关重要。为应对这些挑战而进行的动态调整通常反映了在灵活性-实施和灵活性-依从性领域转向更具解释性的方法，包括更加密集的合规监测以及研究团队对提供干预措施的一线提供者进行详细指导。
在养老院环境中进行的实用试验可能受益于更具动态性的实施方法。允许实用性和解释性特征之间的灵活性可能仍能保持试验对目标利益相关者需求的适用性。PRECIS-2提供了一个有用的形成性评估工具来“实时”评估这些调整。
美国国立医学图书馆，ClinicalTrials.gov，标识符：NCT02612688。于2015年11月19日注册。
