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      A Live Video Program to Prevent Chronic Pain and Disability in At-Risk Adults With Acute Orthopedic Injuries (Toolkit for Optimal Recovery): Protocol for a Multisite Feasibility Study


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          Despite the pivotal role of psychosocial factors in pain and disability after orthopedic injury, there are no evidence-based preventive interventions targeting psychosocial factors in patients with acute orthopedic injuries. We developed the first mind-body intervention focused on optimizing recovery and improving pain and disability in patients with acute orthopedic injuries who exhibit high levels of catastrophic thinking about pain and/or pain anxiety (Toolkit for Optimal Recovery [TOR] after orthopedic injury). In a pilot single-site randomized controlled trial (RCT), the TOR met a priori set benchmarks for feasibility, acceptability, and satisfaction. The next step in developing TOR is to conduct a multisite feasibility RCT to set the stage for a scientifically rigorous hybrid efficacy-effectiveness trial.


          The objective of this study is to conduct a rigorous multisite feasibility RCT of TOR to determine whether the intervention and study methodology meet a priori set benchmarks necessary for the successful implementation of a future multisite hybrid efficacy-effectiveness trial. In this paper, we describe the study design, manualized treatments, and specific strategies used to conduct this multisite feasibility RCT investigation.


          This study will be conducted at 3 geographically diverse level 1 trauma centers, anonymized as sites A, B, and C. We will conduct a multisite feasibility RCT of TOR versus the minimally enhanced usual care (MEUC) control (60 patients per site; 30 per arm) targeting a priori set feasibility benchmarks. Adult patients with acute orthopedic injuries who endorse high pain catastrophizing or pain anxiety will be recruited approximately 1-2 months after injury or surgery (baseline). Participants randomized to the TOR will receive a 4-session mind-body treatment delivered via a secure live video by trained clinical psychologists. Participants randomized to the MEUC will receive an educational booklet. Primary outcomes include feasibility of recruitment, appropriateness, feasibility of data collection, acceptability of TOR (adherence to sessions), and treatment satisfaction across all sites. We will also collect data on secondary implementation outcomes, as well as pain severity, physical and emotional function, coping skills, and adverse events. Outcomes will be assessed at baseline, posttreatment, and at the 3-month follow-up.


          Enrollment for the RCT is estimated to begin in June 2021. The target date of completion of the feasibility RCT is April 2024. The institutional review board approval has been obtained (January 2020).


          This investigation examines the multisite feasibility of TOR administered via live videoconferencing in adult patients with acute orthopedic injuries. If feasible, the next step is a multisite, hybrid efficacy-effectiveness trial of TOR versus MEUC. Preventive psychosocial interventions can provide a new way to improve patient and provider satisfaction and decrease suffering and health care costs among patients with orthopedic injuries who are at risk for chronic pain and disability.

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          Most cited references55

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          The CES-D Scale: A Self-Report Depression Scale for Research in the General Population

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            Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda

            An unresolved issue in the field of implementation research is how to conceptualize and evaluate successful implementation. This paper advances the concept of “implementation outcomes” distinct from service system and clinical treatment outcomes. This paper proposes a heuristic, working “taxonomy” of eight conceptually distinct implementation outcomes—acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability—along with their nominal definitions. We propose a two-pronged agenda for research on implementation outcomes. Conceptualizing and measuring implementation outcomes will advance understanding of implementation processes, enhance efficiency in implementation research, and pave the way for studies of the comparative effectiveness of implementation strategies.
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              A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project

              Background Identifying, developing, and testing implementation strategies are important goals of implementation science. However, these efforts have been complicated by the use of inconsistent language and inadequate descriptions of implementation strategies in the literature. The Expert Recommendations for Implementing Change (ERIC) study aimed to refine a published compilation of implementation strategy terms and definitions by systematically gathering input from a wide range of stakeholders with expertise in implementation science and clinical practice. Methods Purposive sampling was used to recruit a panel of experts in implementation and clinical practice who engaged in three rounds of a modified Delphi process to generate consensus on implementation strategies and definitions. The first and second rounds involved Web-based surveys soliciting comments on implementation strategy terms and definitions. After each round, iterative refinements were made based upon participant feedback. The third round involved a live polling and consensus process via a Web-based platform and conference call. Results Participants identified substantial concerns with 31% of the terms and/or definitions and suggested five additional strategies. Seventy-five percent of definitions from the originally published compilation of strategies were retained after voting. Ultimately, the expert panel reached consensus on a final compilation of 73 implementation strategies. Conclusions This research advances the field by improving the conceptual clarity, relevance, and comprehensiveness of implementation strategies that can be used in isolation or combination in implementation research and practice. Future phases of ERIC will focus on developing conceptually distinct categories of strategies as well as ratings for each strategy’s importance and feasibility. Next, the expert panel will recommend multifaceted strategies for hypothetical yet real-world scenarios that vary by sites’ endorsement of evidence-based programs and practices and the strength of contextual supports that surround the effort. Electronic supplementary material The online version of this article (doi:10.1186/s13012-015-0209-1) contains supplementary material, which is available to authorized users.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                April 2021
                28 April 2021
                : 10
                : 4
                : e28155
                [1 ] Integrated Brain Health Clinical and Research Program Massachusetts General Hospital Boston, MA United States
                [2 ] Harvard Medical School Boston, MA United States
                [3 ] Department of Psychiatry and Human Behavior Alpert Medical School Brown University Providence, RI United States
                [4 ] Center for Healthcare Organization and Implementation Research VA Bedford Healthcare System Bedford, MA United States
                [5 ] Department of Orthopaedic Surgery & Sports Medicine College of Medicine University of Kentucky Lexington, KY United States
                [6 ] Department of Orthopaedic Surgery Massachusetts General Hospital Boston, MA United States
                [7 ] Department of Surgery and Perioperative Care Dell Medical School The University of Texas at Austin Austin, TX United States
                Author notes
                Corresponding Author: Ana-Maria Vranceanu avranceanu@ 123456mgh.harvard.edu
                Author information
                ©Ana-Maria Vranceanu, Jafar Bakhshaie, Mira Reichman, James Doorley, A Rani Elwy, Cale Jacobs, Neal Chen, John Esposito, David Laverty, Paul E Matuszewski, Amirreza Fatehi, Lucy C Bowers, Mitchel Harris, David Ring. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.04.2021.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 23 February 2021
                : 9 March 2021
                Custom metadata
                This paper was peer reviewed by the National Center for Complementary and Integrative Health Special Emphasis Panel, Exploratory Clinical Trials of Mind and Body Interventions (National Institutes of Health). See the Multimedia Appendix for the peer-review report;

                orthopedic,musculoskeletal,prevention,chronic pain,disability,intervention,video,telehealth,mobile phone


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