Gastroenterology · Medical Literature
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.
Abstract
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. 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. 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. 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.
Clinical relevance
Among IBD patients enrolled in the IBD-BOOST RCT, did facilitators adhere to the protocol for delivering a digital cognitive-behavioural self-management intervention, and what were facilitators' perspectives on training, delivery, workload, and implementation? __SNAPSHOT__ {"studyDesign":"Mixed-methods process evaluation nested within a randomised controlled trial (RCT); quantitative fidelity assessment of participant–facilitator messages using a bespoke framework, plus reflexive thematic analysis of semi-structured interviews with facilitators","setting":"United Kingdom; multi-site NHS (4 participating sites); affiliated primarily with King's College London (Florence Nightingale Faculty and Institute of Psychiatry, Psychology and Neuroscience)","sampleSize":"19 facilitators interviewed pre- and post-intervention delivery; message fidelity assessed on a randomised sample of participant–facilitator in-programme messages (exact n of messages not reported in abstract). Parent RCT: n=780 participants (391 IBD-BOOST, 389 care as usual)","population":"Facilitators (likely IBD nurses or allied health professionals) supporting adults with IBD (Crohn's disease or ulcerative colitis) who reported clinically meaningful fatigue, pain, and/or faecal urgency/incontinence and who expressed a desire for intervention; parent trial mean age 49 years, 66.7% female, 55% Crohn's disease","intervention":"IBD-BOOST: a 12-session digital, interactive, cognitive-behavioural self-management programme for fatigue, pain, and faecal urgency/incontinence, delivered with facilitator support via one telephone call and asynchronous in-platform messaging, plus structured training and ongoing supervision for facilitators","comparator":"Not applicable (this is a process evaluation of the facilitator arm only; parent RCT comparator was care as usual)","primaryOutcome":"Facilitator fidelity to protocol (assessed via bespoke fidelity framework applied to randomised in-programme messages) and facilitator experience (themes derived from pre- and post-delivery semi-structured interviews)","followUp":"Duration of facilitator follow-up not reported; intervention access period for patients was 6 months per the parent RCT protocol","fundingSource":"National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research (PGfAR), grant reference NIHR RP-PG-0216-20001; government-funded"}
Key findings
Based on the provided abstract (full text not available), facilitators demonstrated high fidelity to the IBD-BOOST trial protocol throughout the intervention delivery period, as assessed by the bespoke fidelity framework applied to a randomised sample of in-programme messages. Qualitative thematic analysis of interviews with 19 facilitators identified that: (1) facilitators valued the IBD-BOOST intervention and believed it addressed a genuine unmet clinical need; (2) facilitators felt that training and ongoing supervision adequately equipped them for their role; and (3) facilitators expressed concerns regarding workload-related issues (abstract truncated; specific thematic labels and sub-themes beyond workload not reported). No quantitative fidelity scores, effect sizes, confidence intervals, or p-values pertaining to fidelity outcomes are reported in the abstract. Results of the parent RCT, reported separately, showed no statistically significant difference in the co-primary outcomes — UK-IBDQ (mean difference: −1.67, 95% CI: −4.17 to 0.83, p=0.19) and global rating of symptom relief (mean difference: 0.44, 95% CI: −0.56 to 1.43, p=0.39) — at 6 months. Secondary outcomes of faecal incontinence and EQ-5D utility score were significantly in favour of IBD-BOOST at 6 months; pain and fatigue scores were not different. Only 57% of intervention participants completed the pre-defined minimum dose of 4 sessions. NNT: not calculable from process evaluation data.
Practice implications
This facilitator-focused process evaluation established that the null result of the parent IBD-BOOST RCT was not attributable to facilitator infidelity or inadequate training — facilitators adhered to the protocol with high fidelity and felt well-prepared. This is an important interpretive finding: it rules out delivery failure as an explanation for the RCT's primary outcome failure, and shifts attention toward other potential explanations such as suboptimal patient engagement (only 57% of participants completed ≥4 sessions), intervention design, patient selection, or insufficient dose. The findings apply specifically to the facilitator workforce in a UK NHS setting and cannot be generalised to self-directed (unfacilitated) digital interventions or non-NHS healthcare contexts. Patients not adequately represented include those with severe active IBD flares, comorbid significant mental health conditions, or those lacking digital literacy, as the RCT recruited motivated individuals expressing a desire for intervention. The process evaluation does not, by itself, provide evidence to change clinical practice, but it contextualises the RCT null result by confirming implementation integrity. Importantly, the abstract was truncated and full thematic analysis of facilitator concerns — particularly regarding workload — could not be fully evaluated. Only the abstract was available; the complete paper may contain additional fidelity metrics and thematic detail that would affect interpretation. __LIMITATIONS__ Only the abstract was available for review; full thematic results, fidelity scoring methodology, and complete qualitative findings are not assessable.,Abstract was truncated mid-sentence; concerns expressed by facilitators regarding workload and potentially other themes are incompletely reported.,Sample limited to 19 facilitators; representativeness across professional roles, experience levels, and sites is not reported.,The randomised sample of messages used for fidelity assessment is not quantified, and inter-rater reliability of the bespoke fidelity framework is not reported in the abstract.,Qualitative findings from facilitators may reflect social desirability bias, particularly in pre-intervention interviews where enthusiasm for a newly trained role may inflate positive appraisals.,Process evaluation cannot determine why 43% of participants failed to complete the minimum dose; patient-level barriers are addressed in a parallel patient-perspective process evaluation (PMID 41236397), not this study.,Generalisability is limited to NHS facilitator-supported digital interventions in a UK IBD population; findings may not transfer to healthcare systems with different nursing workforce structures or digital infrastructure.,The bespoke fidelity framework was developed specifically for this study; its psychometric properties and benchmarks for 'high fidelity' are not defined in the abstract.,Government funding (NIHR) is a relative strength, but the programme was large and multi-investigator; some named investigators reported speaker fees and research funding from pharmaceutical companies (e.g., Czuber-Dochan: Bristol Myers Squibb, Dr. Falk, Pharmacosmos), which should be considered when interpreting programmatic conclusions. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ High facilitator fidelity throughout the IBD-BOOST RCT delivery confirms that the trial's null primary outcomes cannot be attributed to poor protocol adherence or inadequate facilitator preparation. Clinicians and researchers should look beyond delivery failure — toward patient engagement (only 57% dose completion), intervention design, or patient selection — as explanations for the absence of effect on IBD-related quality of life and symptom relief. This process evaluation is hypothesis-generating for redesign of digital self-management programmes in IBD rather than immediately practice-changing.