Prevention and treatment of incontinence-associated dermatitis through optimising care: the PREVENT-IAD Synopsis.

Abstract

Incontinence-associated dermatitis is prevalent in long-term care facilities and homecare settings among 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 (Incontinence-Associated Dermatitis Manual) to prevent and treat incontinence-associated dermatitis in long-term care facilities and homecare settings. This was a three-phase study: (1) evidence synthesis and intervention development, (2) definitive study design (a cluster-randomised controlled trial with an embedded process evaluation) and (3) a 3-month feasibility study. Our Cochrane review was updated following a similar methodology to the original review. The intervention (underpinned by findings from the Cochrane review) was developed with 16 stakeholders. The feasibility study targeted four long-term care facilities and two homecare providers, randomising them (each as a cluster) to intervention or control. Recruitment targeted 288 participants (48 per cluster). Feasibility outcomes included recruitment and retention rates, completeness of data, acceptability of intervention and methods and intervention fidelity. Outcome measures included: Ghent Global incontinence-associated dermatitis categorisation tool, minimum data set and incontinence-associated dermatitis intervention tool. Process evaluation interviews with two care recipients, 11 family carers and 13 care staff implementing the Incontinence-Associated Dermatitis Manual and their managers were conducted. Observations of 22 episodes of care assessed intervention fidelity. Qualitative data were analysed using thematic analysis. Summary feasibility outcome measures using means or proportions, together with 95% confidence intervals, were reported. The reviews of interventions for prevention and treatment of incontinence-associated dermatitis included 15 trials with 1089 participants and 19 trials with 1164 participants, respectively. All participants were incontinent of urine, stool or both. Little evidence, of very low to low quality, was found on the effects of interventions for preventing and treating incontinence-associated dermatitis in adults. The proposed cluster-randomised controlled trial was agreed, with one additional outcome measure added, and the co-designed intervention (incontinence-associated dermatitis manual) included training (3 hours face-to-face and online), an online manual and a poster/flow chart to support care decision-making. After a COVID-19-related pause of 7 months, obtaining governance and ethical approvals for the feasibility study was delayed by 27 months. Five sites were recruited from 49 approached. All randomised sites were retained. Seventy-six (16%) of the 477 participants approached were randomised, of which 58 (76%) completed the study. Ghent Global incontinence-associated dermatitis categorisation tool, minimum data set and incontinence-associated dermatitis intervention tool had complete or almost-complete 3-month outcome data in participants, whereas other outcome measures had contrastingly poor data completeness due to participant cognitive impairment. Process evaluation showed few potential participants had capacity to consent, and gaining consultee approval was challenging. Care staff liked the incontinence-associated dermatitis manual, describing it as '<i>helpful</i>'. Twenty-eight people accessed the incontinence-associated dermatitis manual online, and 15 care staff downloaded a certificate of completion of training. Intervention fidelity was not always observed. The study was limited by the impact of COVID on both the social care sector and research governance systems and processes. The prevalence of incontinence-associated dermatitis in study sites was lower than expected. It was feasible to develop the Incontinence-Associated Dermatitis Manual. The randomised controlled trial was not feasible as designed, with specific challenges regarding site and participant recruitment, governance and intervention fidelity. We plan to revise the methods used in this feasibility study to address limitations, especially issues of recruitment, and develop a protocol for a new trial with nested feasibility study. This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128865. To develop a manual and training to guide the way incontinence-associated dermatitis is prevented and treated, working with people with incontinence-associated dermatitis, their carers and health professionals. Design a study to find out if the manual works to prevent and treat incontinence-associated dermatitis and could be tested on a larger group of people. Assess if our study design would work in the real world. The study had three parts. Part 1. We looked for evidence and worked with five people with incontinence-associated dermatitis/their family and 16 health professionals to develop the manual and training. Part 2. We worked with the same people to design a future study to test if the manual works to reduce incontinence-associated dermatitis. Part 3. We did a smaller study to see if the trial we designed could be done. We recruited three care homes and two homecare agencies. Three sites had training in using the manual, and the other two provided usual care. Over 3 months, we recorded how many people joined and stayed in the study. We watched carers and asked them and people they cared for what they thought about the manual. We developed a flow chart and online training (the Incontinence-Associated Dermatitis Manual) to guide care. Seventy-six people joined the study from 477 asked (16%), and 62 remained at 3 months. Some data collection worked well, but some did not. Care staff did not always follow the steps in the Incontinence-Associated Dermatitis Manual. Carers liked the manual but did not always follow it. The study we planned did not work well. The plan needs changing before attempting a larger study.