IMPLEMENTATION CHALLENGES OF A COMMUNITY-BASED PRAGMATIC RANDOMIZED CONTROLLED TRIAL IN WOUND CARE

<>Purpose:

   A retrospective critical reflection on the challenges encountered during the implementation of the community-based Wound Interdisciplinary Team (WIT) study.

  <>Method:

   The Wound Interdisciplinary Team (WIT) study is a two-arm pragmatic randomized controlled trial evaluating the effectiveness and cost effectiveness of a systematic referral process to improve primary care access to multidisciplinary wound care teams (MDWCTs) in Toronto from May 2011 to May 2013.

   We developed a critical reflection framework to identify and understand the implementation challenges and their impact on the trial's outcomes using different instruments/tools including field notes from direct observations, informal discussions, semi-structured interviews and client satisfaction questionnaire (CSQ8 ScaleŽ).

      We evaluated different implementation processes, such as recruitment, informed consent, target population sampling, systematic referral to MDWCTs, and appointment scheduling and attendance with the MDWCTs. The identified challenges were further verified with a review of the study protocol and the community practice and correlated with the quantitative results.

  <>Result:

   Four hundred and fifty-one patients referred for community-based wound care were enrolled; 225 patients were allocated to the control arm and 226 patients to the intervention arm.

   There were multiple challenges that might have affected the study outcomes. While some challenges were anticipated and addressed, others only became apparent during the course of the study. Anticipated challenges included study integration into the community practice setting and training of community members unfamiliar with research ethics and procedures. Unanticipated challenges were mainly context- or study design-driven.  Complex logistics for subject enrollment and data collection constituted major barriers. Issues related to the pragmatic trial design reduced the number of subjects eligible for intervention and potentially reduced the impact of intervention.

   For future community-based healthcare research, we strongly recommend early involvement and collaboration with frontline healthcare professionals, simplification of logistics, piloting the study, pre-trial modeling, and mixed methods design for process evaluation.

  <>Conclusion:

   The implementation of community-based pragmatic trials in wound care is complex. Early community engagement and thorough understanding of community capacity is crucial. The lessons learned will contribute to the field of community-based health care research.