PREVENTion and treatment of Incontinence-Associated Dermatitis (IAD) through optimising care: development and feasibility cluster randomised trial of the IAD-Manual (PREVENT-IAD).

BACKGROUND

Incontinence-associated dermatitis (IAD) is prevalent in long-term care (LTC) facilities and homecare settings amongst adults who are incontinent of urine and/or faeces. Strategies to protect skin integrity are needed. This study aimed to co-design and test the feasibility of a training manual and care guidance (IAD-Manual) to prevent and treat IAD in LTC facilities and homecare settings.

METHODS

This was a three-phase study: (1) developing the intervention, (2) designing the empirical study (a cluster RCT with an embedded process evaluation) to assess its effectiveness (not reported here) and (3) a 3-month feasibility study. The feasibility study recruited three LTC facilities and two homecare providers, randomising them (each as a cluster) to intervention or control. Process evaluation interviews with two care recipients, 11 family carers and 13 care staff implementing the IAD-Manual and their managers were conducted. Observations of 22 episodes of care assessed fidelity to the intervention. Qualitative data were analysed using thematic analysis. Summary feasibility outcome measures using means or proportions together with 95% confidence intervals were reported.

RESULTS

Five sites were recruited from 49 approached. All randomised sites were retained. Seventy-six (16% [95% CI: 13-20%]) of the 477 participants approached were randomised, of which 58 (76% [95% CI: 65-85%]) completed the study. Candidate IAD outcomes had complete or almost-complete 3-month outcome data in those participants remaining, whereas other outcome measures had contrastingly poor data completeness largely due to participant cognitive impairment. Process evaluation showed few potential participants had the capacity to consent, and gaining consultee approval was challenging. Care staff at study sites liked the IAD-Manual, describing it as 'helpful'. Twenty-eight people accessed the IAD-Manual online, and 15 care staff downloaded a certificate of completion of training. Intervention fidelity was not always observed.

CONCLUSIONS

It was feasible to develop the IAD-Manual. The RCT as designed was not feasible in its original form, with specific challenges regarding site and participant recruitment, governance and intervention fidelity.

TRIAL REGISTRATION: This trial was prospectively registered on 07/02/2020 (intervention development) ISRCTN26169429 and 28/02/2024 (feasibility study) ISRCTN70866724.