School of Health Policy & Management, Faculty of Health, York University, Toronto, Ontario, M3J 1P3, Canada.
Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G 1C9, Canada.
Implement Sci. 2020 Sep 16;15(1):78. doi: 10.1186/s13012-020-01039-2.
Fidelity in complex behavioral interventions is underexplored. This study examines the fidelity of the INFORM trial and explores the relationship between fidelity, study arm, and the trial's primary outcome-care aide involvement in formal team communications about resident care.
A concurrent process evaluation of implementation fidelity was conducted in 33 nursing homes in Western Canada (Alberta and British Columbia). Study participants were from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced-Assisted Feedback arms of the INFORM trial.
Fidelity of the INFORM intervention was moderate to high, with fidelity delivery and receipt higher than fidelity enactment for both study arms. Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) = 4.27, p = .042).
Overall fidelity enactment was associated with improvements in formal team communications, but the study arm was not. This suggests that the intensity with which an intervention is offered and delivered may be less important than the intensity with which intervention participants enact the core components of an intervention. Greater attention to fidelity assessment and publication of fidelity results through studies such as this one is critical to improving the utility of published trials.
复杂行为干预措施的保真度研究较少。本研究考察了 INFORM 试验的保真度，并探讨了保真度、研究组与试验主要结局（护理助手正式参与关于居民护理的团队沟通）之间的关系。
在加拿大西部（艾伯塔省和不列颠哥伦比亚省）的 33 家养老院中进行了一项 INFORM 试验实施保真度的同期过程评估。研究参与者来自 106 个临床护理单元，这些单元聚类在 33 家随机分配到 INFORM 试验基本组和增强辅助反馈组的养老院中。
INFORM 干预措施的保真度为中等到高度，对于两个研究组，干预措施的传递和接收都高于实施。实施程度较高的团队在基线和随访之间的正式团队沟通方面的改善明显大于实施程度较低的团队（F（1，70）=4.27，p=.042）。
总体实施保真度与正式团队沟通的改善相关，但研究组则不然。这表明，干预措施的提供和实施的强度可能不如干预措施参与者实施干预措施核心组成部分的强度重要。通过像这样的研究更加关注保真度评估和发布保真度结果，对于提高已发表试验的实用性至关重要。
