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2023 HSR&D/QUERI National Conference Abstract

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1064 — Facilitating Future Implementation and Translation to Clinical Practice: The Implementation Planning Assessment Tool

Lead/Presenter: Christine Kowalski,  COIN - Ann Arbor
All Authors: Kowalski CP (Center for Evaluation and Implementation Resources, VA Ann Arbor Healthcare System and Center for Clinical Management Research, VA Ann Arbor), L Kawentel (Center for Evaluation and Implementation Resources, VA Ann Arbor Healthcare System) TC Kyriakides (Cooperative Studies Program Coordinating Center, VA CT Healthcare System, West Haven, CT) L Davis (Tuscaloosa VA Medical Center Research Service and University of Alabama Heersink School of Medicine, Department of Psychiatry and Behavioral Neurobiology) NW Bowersox (Center for Evaluation and Implementation Resources, VA Ann Arbor Healthcare System) AM Kilbourne (Department of Learning Health Sciences, University of Michigan and Office of Research and Development, Veterans Health Administration, Washington, DC) GD Huang (Office of Research and Development, Veterans Health Administration, Washington, DC) AL Nevedal (Center for Innovation to Implementation, VA Palo Alto Healthcare System)

Without a proactive plan to implement clinical trial findings, it can take decades for one-fifth of effective interventions to be adopted into routine care settings. There is a dearth of tools to prepare treatments or programs for implementation that are feasible to use across the translation spectrum. To address knowledge gaps in the literature about incorporating implementation planning in clinical trials, our objective is to introduce a newly developed Implementation Planning Assessment (IPA) Tool that any trialist or researcher may use throughout initial studies to support future trials or research to understand the implementation of effective interventions. We also provide a case study demonstrating use of the tool.

The tool was developed through a systematic process by an interdisciplinary team with expertise in implementation science, clinical trials, program evaluation, and qualitative methods; team meetings with an organized set of agendas over a period of time were used to develop and refine the tool.

The tool emphasizes three phases to accelerate the adoption of interventions into routine clinical care: Phase 1, “Planning, Framing, and Aligning Interested Parties,” involves identification and garnering of input from multilevel interested parties who have a vested interest in the trial’s results and potentially the leverage to incorporate results or effective treatments into routine practice via organizational changes. Phase 2, “Implementation Process Data Collection,” involves planning and assessment by clinical and research leaders that will promote uptake of the intervention, if found effective, and the enactment of an implementation plan. Phase 3 “Planning for Sustainment for Effective Trials,” takes results from phases 1-2 to outline a process by which trial results and interventions will be adopted in routine practice. Throughout all phases, the assessment team should also plan for dissemination, which involves sharing information about the intervention, implementation, and trial results to increase uptake among key interested parties. After the tool was developed, it was applied retrospectively in a completed clinical trial; this highlighted the concrete impact of missed opportunities that could have been addressed had the tool been available for use as part of the trial’s planning and execution process.

This tool, anchored in implementation science principles, provides a much-needed, practical guide for VA researchers working across the translation spectrum who are aiming to scale-up and spread effective, clinical-trial-tested interventions that would ultimately improve the healthcare of patients.

The IPA Tool will help catapult the field of clinical trial inquiry into a new realm of applied science. This tool brings a ready-made list of necessary steps for trialists and researchers aiming to improve implementation, including scale-up and spread, of effective, clinical-trial-tested interventions in health care settings. It can also be utilized by clinicians and health services researchers who are new to the field of implementation science. Although this tool was designed and applied in a VA healthcare setting, its underlying principles are drawn from the field of implementation science and are broader than the VA context alone and can be applied to other health care settings with little work to adapt.