Development of a Feasible Implementation Fidelity Protocol Within a Complex Physical Therapy-Led Self-Management Intervention.

BACKGROUND: Implementation fidelity is poorly addressed within physical therapy interventions, which may be due to limited research on how to develop and implement an implementation fidelity protocol.
OBJECTIVE: The purpose of this study was to develop a feasible implementation fidelity protocol within a pilot study of a physical therapy-led intervention to promote self-management for people with chronic low back pain or osteoarthritis.
DESIGN: A 2-phase mixed-methods design was used.
METHODS: Phase 1 involved the development of an initial implementation fidelity protocol using qualitative interviews with potential stakeholders to explore the acceptability of proposed strategies to enhance and assess implementation fidelity. Phase 2 involved testing and refining the initial implementation fidelity protocol to develop a finalized implementation fidelity protocol. Specifically, the feasibility of 3 different strategies (physical therapist self-report checklists, independently rated direct observations, and audio-recorded observations) for assessing implementation fidelity of intervention delivery was tested, followed by additional stakeholder interviews that explored the overall feasibility of the implementation fidelity protocol.
RESULTS: Phase 1 interviews determined the proposed implementation fidelity strategies to be acceptable to stakeholders. Phase 2 showed that independently rated audio recordings (n=6) and provider self-report checklists (n=12) were easier to implement than independently rated direct observations (n=12) for assessing implementation fidelity of intervention delivery. Good agreement (79.8%-92.8%) was found among all methods. Qualitative stakeholder interviews confirmed the acceptability, practicality, and implementation of the implementation fidelity protocol. LIMITATIONS: The reliability and validity of assessment checklists used in this study have yet to be fully tested, and blinding of independent raters was not possible.
CONCLUSIONS: A feasible implementation fidelity protocol was developed based on a 2-phase development process involving intervention stakeholders. This study provides valuable information on the feasibility of rigorously addressing implementation fidelity within physical therapy interventions and provides recommendations for researchers wanting to address implementation fidelity in similar areas.