@article{332ae52e6a6b41ecb28e32482ce4e84c,
title = "Implementation of Complex Interventions: Lessons Learned from the Patient-Centered Outcomes Research Institute Transitional Care Portfolio",
abstract = "Background: Despite the well-documented risks to patient safety associated with transitions from one care setting to another, health care organizations struggle to identify which interventions to implement. Multiple strategies are often needed, and studying the effectiveness of these complex interventions is challenging. Objective: The objective of this study was to present lessons learned in implementing and evaluating complex transitional care interventions in routine clinical care. Research Design: Nine transitional care study teams share important common lessons in designing complex interventions with stakeholder engagement, implementation, and evaluation under pragmatic conditions (ie, using only existing resources), and disseminating findings in outlets that reach policy makers and the people who could ultimately benefit from the research. Results: Lessons learned serve as a guide for future studies in 3 areas: (1) Delineating the function (intended purpose) versus form (prespecified modes of delivery of the intervention); (2) Evaluating both the processes supporting implementation and the impact of adaptations; and (3) Engaging stakeholders in the design and delivery of the intervention and dissemination of study results. Conclusion: These lessons can help guide future pragmatic studies of care transitions.",
keywords = "comparative effectiveness research, complex health inventions, core functions and forms, patient engagement, pragmatic clinical trial",
author = "Gesell, {Sabina B.} and {Prvu Bettger}, Janet and Lawrence, {Raymona H.} and Jing Li and Jeanne Hoffman and Lutz, {Barbara J.} and Corita Grudzen and Johnson, {Anna M.} and Krishnan, {Jerry A.} and Hsu, {Lewis L.} and Dorien Zwart and Williams, {Mark V.} and Schnipper, {Jeffrey L.}",
note = "Funding Information: J.L.S. reports being the recipient of an investigator-initiated grant from Mallinckrodt Pharmaceuticals to study opioid-related adverse drug events in postsurgical inpatients. J.A.K. reports being the recipient of research grants from the Sergey Brin Family Foundation, Regeneron/Department of Health and Human Services, and the National Heart, Lung, and Blood Institute. The remaining authors declare no conflict of interest. Funding Information: Frequent changes in institutional and health policies, patients{\textquoteright} needs, and local resources create a challenging environment for addressing care transitions and studying interventions in ways that are both valid and generalizable. This paper presents lessons learned from the portfolio of care transition studies funded by the Patient-Centered Outcomes Research Institute (PCORI). Three major themes are examined through the review of case studies: (1) Delineating function (intended purpose) versus form (prespecified modes of delivery of the intervention); (2) Evaluating both the processes supporting implementation and the impact of adaptations; and (3) Engaging stakeholders in the design and delivery of the intervention and dissemination of study results. We highlight the complexities of conducting such studies, offer lessons learned from our experiences, and provide exemplars to inform future research. Publisher Copyright: {\textcopyright} 2021 Lippincott Williams and Wilkins. All rights reserved.",
year = "2021",
month = aug,
day = "1",
doi = "10.1097/MLR.0000000000001591",
language = "English",
volume = "59",
pages = "S344--S354",
journal = "Medical care",
issn = "0025-7079",
}