Optimizing the implementation of a multisite feasibility trial of a mind-body program in acute orthopedic trauma.

The Toolkit for Optimal Recovery (TOR) is a mind-body program for patients with acute orthopedic injuries who are at risk for persistent pain/disability. In preparation for a multisite feasibility trial of TOR at three orthopedic trauma centers, we aim to qualitatively identify barriers and facilitators to study implementation and strategies to mitigate the implementation barriers and leverage facilitators.We conducted 18 live video focus groups among providers and three one-on-one interviews with department chiefs at Level 1 trauma centers in three geographically diverse sites (N = 79 participants). Using a content analysis approach, we detected the site-specific barriers and facilitators of implementation of TOR clinical trial. We organized the data according to 26 constructs of the Consolidated Framework for Implementation Research (CFIR), mapped to three Proctor implementation outcomes relevant to the desired study outcomes (acceptability, appropriateness, and feasibility). Across the three sites, we mapped six of the CFIR constructs to acceptability, eight to appropriateness, and three to feasibility. Prominent perceived barriers across all three sites were related to providers' lack of knowledge/comfort addressing psychosocial factors, and organizational cultures of prioritizing workflow efficiency over patients' psychosocial needs (acceptability), poor fit between TOR clinical trial and the fast-paced clinic structure as well as basic needs of some patients (appropriateness), and limited resources (feasibility). Suggestions to maximize the implementation of the TOR trial included provision of knowledge/tools to improve providers' confidence, streamlining study recruitment procedures, creating a learning collaborative, tailoring the study protocol based on local needs assessments, exercising flexibility in conducting research, dedicating research staff, and identifying/promoting champions and using novel incentive structures with regular check-ins, while keeping study procedures as nonobtrusive and language as de-stigmatizing as possible. These data could serve as a blueprint for implementation of clinical research and innovations in orthopedic and other medical settings.