Supporting patients using a digital self-management intervention for symptoms of fatigue, pain, and urgency/incontinence in Inflammatory Bowel Disease: a mixed methods process evaluation of trial facilitators

BACKGROUND: A randomised controlled trial (RCT) of a facilitator-supported digital programme (IBD-BOOST) for symptom management in Inflammatory Bowel Disease found no difference in disease-specific quality of life and symptom relief compared with controls. Process evaluation is necessary to inform the interpretation of trial outcomes. This study evaluated facilitator adherence to intervention delivery and facilitator perspectives on training, intervention delivery and supervision during the trial, and implementation. METHODS: A mixed-methods process-evaluation study nested within an RCT. A randomised sample of participant-facilitator in-programme messages during the intervention were assessed using a bespoke fidelity assessment framework. Semi-structured interviews were conducted with nineteen facilitators pre and post intervention delivery and assessed using reflexive thematic analysis. RESULTS: Facilitators adhered to the trial protocol for intervention delivery achieving high fidelity throughout. Qualitative interviews revealed facilitators valued the IBD-BOOST intervention and felt the training and on-going supervision equipped them well for the task. Facilitators expressed concerns regarding workload-related time constraints during the trial and cautioned that similar implementation challenges may arise if the intervention were delivered within routine clinical care. CONCLUSION: This process evaluation demonstrated that, although the overall trial outcomes were unsuccessful, this was not attributable to facilitator infidelity in intervention fidelity or a lack of enthusiasm for the intervention. Instead, other factors, including participant engagement, may have played a significant role in the limited effectiveness observed. Further investigation is needed to identify and address these contributing factors, which could include barriers to participant engagement or potential misalignment between the intervention design and the needs and expectations of its target population.