Fisher Kathryn, Carusone Soo Chan, Ganann Rebecca, Markle-Reid Maureen, Northwood Melissa, Sherifali Diana
Faculty of Health Sciences, Aging and Community Health Research Unit, School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.
Trials. 2025 May 13;26(1):154. doi: 10.1186/s13063-025-08839-1.
This study aimed to test the effectiveness and implementation of a complex integrated care intervention for older adults. We collected both quantitative and qualitative data, which is recommended in evaluating complex interventions to gain a comprehensive understanding of key success factors. Often, congruence is sought and considered desirable when integrating the findings from both data types. However, data are not always congruent, nor is it suboptimal when incongruence occurs, as we illustrate in this case study. We present the divergent findings from a large community-based implementation-effectiveness hybrid type II trial, and how the struggle to reconcile incongruent results yielded rich insights informing the next steps for translational research on the intervention being tested.
Previous foundational research, including a pilot study and randomized controlled trial (RCT), showed promising results and supported proceeding with a multi-site pragmatic hybrid type II effectiveness-implementation RCT. This recent RCT was undertaken and quantitative and qualitative data were collected to inform the effectiveness and implementation evaluation. To synthesize the findings and guide integration of this large body of evidence, we developed a conceptual model which combined two existing frameworks: the Consolidated Framework for Implementation Research and Quintuple Aim. We used this model to identify the evidence and relate it to relevant implementation and intervention determinants/outcomes. We then synthesized the evidence to distall the main messages regarding the future of the intervention, which involved reconciling apparently discrepant findings from the quantitative and qualitative approaches.
The current RCT showed no statistically significant effect for participants for the primary (or secondary) outcomes yet the implementation evaluation consistently found perceived benefits of the intervention for patients, providers, and the healthcare system. Qualitative evidence was critical in understanding contextual factors potentially responsible for the absence of a treatment effect (e.g., COVID-19), strategies to overcome challenges experienced in participant engagement and intervention delivery, and recent policy/practice setting changes which showed strong alignment with the intervention and supported its future implementation.
With the goal of the hybrid type II effectiveness and implementation study in mind, stakeholders encouraged proceeding with a scalability assessment to consider the evidence from the current trial within the context of our prior research, the broader literature for similar interventions, and the ever-changing policy context.
clinicaltrials.gov NCT03664583. Registration date: September 10, 2018.
本研究旨在测试一项针对老年人的复杂综合护理干预措施的有效性及实施情况。我们收集了定量和定性数据，在评估复杂干预措施时推荐采用这种方式，以便全面了解关键成功因素。在整合这两种数据类型的研究结果时，通常会寻求并认为两者一致是理想的。然而，数据并非总是一致的，而且不一致情况出现时也并非次优选择，正如我们在本案例研究中所说明的那样。我们展示了一项基于社区的大型实施-有效性混合型II期试验的不同结果，以及调和不一致结果的努力如何产生了丰富的见解，为正在测试的干预措施的转化研究的下一步提供了信息。
先前的基础研究，包括一项试点研究和随机对照试验（RCT），显示出了有前景的结果，并支持开展一项多地点实用混合型II期有效性-实施RCT。近期开展了这项RCT，并收集了定量和定性数据，以进行有效性和实施情况评估。为了综合研究结果并指导对这大量证据的整合，我们开发了一个概念模型，该模型结合了两个现有框架：实施研究综合框架和五重目标。我们使用这个模型来识别证据，并将其与相关的实施和干预决定因素/结果联系起来。然后，我们综合证据以提炼出关于该干预措施未来的主要信息，这涉及调和定量和定性方法中明显不一致的结果。
当前的RCT显示，对于主要（或次要）结局，参与者没有统计学上的显著效果，但实施情况评估始终发现该干预措施对患者、提供者和医疗保健系统有明显益处。定性证据对于理解可能导致缺乏治疗效果的背景因素（如COVID-19）、克服参与者参与和干预实施中遇到的挑战的策略，以及近期与该干预措施高度一致并支持其未来实施的政策/实践环境变化至关重要。
考虑到混合型II期有效性和实施研究的目标，利益相关者鼓励进行可扩展性评估，以便在我们先前的研究、类似干预措施的更广泛文献以及不断变化的政策背景下，考虑当前试验的证据。
clinicaltrials.gov NCT03664583。注册日期：2018年9月10日。
