Process evaluation of a complex intervention evaluating the effectiveness of home-based rehabilitation in the chronic phase of traumatic brain injury.

PURPOSE: To perform a process evaluation of a randomized controlled trial (RCT) evaluating a manualized intervention aiming to ameliorate long-term symptoms of traumatic brain injury (TBI) by assessing implementation fidelity, delivery context and acceptability of the intervention.

METHODS: Data from 60 participants were collected during recruitment, intervention delivery and outcome data collection in the RCT. Enrollment records, logs and checklists documented the delivery of the intervention (implementation fidelity) and the collaboration with family members and outside collaborators (delivery context). Attendance-rate, self-reported acceptability and willingness to participate in future studies were used to assess the acceptability of the intervention.

RESULTS: The main elements and dose of the intervention were delivered as intended with an excellent adherence to the manual items. Family members co-participated in the intervention for 39 (65%) of the participants. Outside collaborators were contacted for 32 (53%) of the participants. Acceptability scores were high for participants, family members and therapists.

CONCLUSIONS: The intervention was successfully delivered with high acceptability. This process evaluation informs researchers, clinicians and stakeholders about important factors influencing the outcomes of the intervention that should be considered in clinical implementation of rehabilitation interventions.

TRIAL REGISTRATION: Pre-registered 4th of June 2018 at clinicaltrials.gov (NCT03545594).