Facilitating future implementation and translation to clinical practice: The Implementation Planning Assessment Tool for clinical trials.

Christine P Kowalski, Linda M Kawentel, Tassos C Kyriakides, Lori Davis, Nicholas W Bowersox, Amy M Kilbourne, Grant D Huang, Andrea L Nevedal
Author Information
  1. Christine P Kowalski: Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA. ORCID
  2. Linda M Kawentel: Center for Evaluation and Implementation Resources, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.
  3. Tassos C Kyriakides: Cooperative Studies Program Coordinating Center, VA CT Healthcare System, West Haven, CT, USA.
  4. Lori Davis: Tuscaloosa VA Medical Center Research Service, Tuscaloosa, AL, USA.
  5. Nicholas W Bowersox: Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.
  6. Amy M Kilbourne: Department of Learning Health Sciences, University of Michigan, Ann Arbor, MI, USA. ORCID
  7. Grant D Huang: Office of Research and Development, Veterans Health Administration, Washington, DC, USA.
  8. Andrea L Nevedal: Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.

Abstract

Implementation assessment plans are crucial for clinical trials to achieve their full potential. Without a proactive plan to implement trial results, it can take decades for one-fifth of effective interventions to be adopted into routine care settings. The Veterans Health Administration Office of Research and Development is undergoing a systematic transformation to embed implementation planning in research protocols through the Cooperative Studies Program, its flagship clinical research program. This manuscript has two objectives: 1) to introduce an Implementation Planning Assessment (IPA) Tool that any clinical trialist may use to facilitate post-trial implementation of interventions found to be effective and 2) to provide a case study demonstrating the IPA Tool's use. The IPA Tool encourages study designers to initially consider rigorous data collection to maximize acceptability of the intervention by end-users. It also helps identify and prepare potential interested parties at local and national leadership levels to ensure, upon trial completion, interventions can be integrated into programs, technologies, and policies in a sustainable way. The IPA Tool can alleviate some of the overwhelming nature of implementation science by providing a practical guide based on implementation science principles for researchers desiring to scale up and spread effective, clinical trial-tested interventions to benefit patients.

Keywords

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