Award Title: PREVENTion and treatment of Incontinence-Associated Dermatitis (IAD) through optimising care: development and feasibility of the IAD Manual (PREVENT-IAD)
Funder: Department of Health and Social Care

Abstract: Incontinence-associated dermatitis (IAD) is skin damage caused by repeated contact with urine, faeces or both. It causes pain, discomfort, infections and pressure sores. 14 million UK people have urinary incontinence and 6.5 million have bowel problems, but the number with IAD in the UK has not been reliably established. It may affect as many as 51% of people with incontinence living at home and up to 30% in nursing and residential care. Prevention and treatment involves skin cleansing & use of products to protect the skin, alongside continence promotion & correct use of incontinence pads, but there are no specific guidelines for IAD management.  Many people provide this care (e.g. family carers, unregistered care workers, nurses). The risk of developing IAD could be halved using preventative measures. We want to create genuine changes in the way IAD is prevented and treated and will do this by developing and testing a manual (book), that will include a lay version, with training materials._x000D_
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Aims. _x000D_
We want to find out if:_x000D_
1.	We can develop a manual with people with IAD, their carers & health professionals, with a related training package, to guide the prevention & treatment of IAD in care homes & people’s own homes_x000D_
2.	We can work together to design a future research study to establish whether the manual works to prevent and treat IAD and could be tested on a larger group of people_x000D_
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Research Question: Is it feasible to develop, manualise and test a package of care for the prevention and treatment of IAD that can be delivered by a range of NHS and other relevant caregivers?_x000D_
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Design: _x000D_
The study has 3 parts._x000D_
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Part 1.	We will search the literature & work with 10-15 people with IAD/their carers and 10-15 health professionals over 4 meetings to (i) find out how they deal with IAD, (ii) what they need to improve this care, (iii) develop a manual to guide prevention & treatment of IAD, (iv) work out what might help or stop people using the manual, (v) develop a plan to introduce the manual (with a training plan & resources) into care homes & the community._x000D_
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Part 2.	We will work with the same people to design a future study to test if the manual works and can be successfully introduced into a real-word setting._x000D_
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Part 3.	We will carry out a study to see if the trial we have designed can be done. To do this, we will recruit four large care homes & two home care agencies and randomly allocate these using a computer so three sites receive training in using the manual, while the other three will continue to provide usual care. Over 6 months we will (i) record how many sites/people are recruited to/stay in the study (ii) measure rates of IAD & outcomes important to patients, e.g. pain/satisfaction, (iii) find out whether the manual is used as planned by observing its use in practice & interviewing users (iv) ask people about their experience of being in the study, how the manual worked in practice & what helped/stopped them using the manual._x000D_
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Public & patient involvement was key from the start & we worked with patient groups (Bladder Health UK), people with IAD & their carers to develop our plans, so that any changes in care will be of real benefit to patients, carers and health professionals. _x000D_
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When we finish the project we will publicise our findings through professional publications, social media & patient newsletters, patient website (www.continenceproductadvisor.org) & at relevant conferences & events.

Lay Abstract: Background and Rationale_x000D_
Incontinence-associated dermatitis (IAD) is skin damage caused by repeated contact with urine &/or faeces. 14 million adults in the UK have urinary incontinence and 6.5 million have bowel problems, but the incidence of IAD in the UK has not been established. Prevalence of IAD may be up to 51% of people with incontinence living at home and 30% in nursing and residential care. Prevention and treatment involves skin cleansing & application of skin protectants with continence promotion & correct use of incontinence pads, but there are no specific guidelines for IAD management.  Odds of developing IAD may be halved using preventative measures. We want to create genuine changes in the way IAD is prevented & treated in care homes and community settings by developing & testing the feasibility of a protocolised manual (including a lay version) with training materials._x000D_
Research Question _x000D_
Is it feasible to develop, manualise & test a package of care for the prevention & treatment of IAD that can be delivered by a range of NHS & other relevant caregivers? _x000D_
Aims _x000D_
1.	Develop & manualise an optimal care package for the prevention & treatment of IAD (IAD Manual) within care homes & by home care agencies, including a training, implementation & dissemination plan_x000D_
2.	Design a future trial of the clinical & cost-effectiveness of the IAD Manual_x000D_
3.	Conduct a feasibility cluster randomised controlled trial (RCT) of the IAD Manual._x000D_
Methods_x000D_
This two-year, mixed methods study comprises 3 phases, culminating in a new intervention & design for a definitive cluster randomised controlled trial (RCT) of the IAD Manual._x000D_
Phase 1:Evidence synthesis and development of the IAD-Manual, training and implementation plan(0-12m)_x000D_
We will update our Cochrane review(1) & purposively sample 10-15 health professionals and 10-15 patients/family carers as stakeholders in a series of 4 interactive 1-day workshops to co-design the IAD Manual, training & implementation plan. We will develop & test a logic model of the active components within the intervention and causal assumptions. Qualitative data will be analysed using framework analysis. _x000D_
Phase 2: Design future cluster RCT of the IAD Manual(9-12m)_x000D_
We will work with the same stakeholders from phase 1 to co-design a future definitive cluster RCT to test the clinical & cost-effectiveness of the IAD manual._x000D_
Phase 3: Feasibility cluster RCT of the IAD Manual & nested process evaluation(12-24m)_x000D_
4 large care homes & 2 care agencies will be recruited & randomised: 3 to implement the IAD manual, 3 usual care (control). Participants with incontinence will be recruited (48 per site)._x000D_
Data collection – Feasibility outcomes (recruitment rates/attrition) & core outcomes for IAD will be recorded using validated outcome measures (GLOBIAD, IADIT, Wong-Baker Faces Scale, SAPS) at baseline, 3m & 6m. Intervention fidelity will be observed at 3m & 6m by non-participant observation. Up to 20 patients/family members/care staff will be interviewed about acceptability of the IAD Manual & study design _x000D_
Data analysis- a process evaluation, based on the logic model from Phase 1, will be conducted. Qualitative data will be analysed thematically & prevalence, incidence & standard deviations of quantitative outcome measures of IAD will inform sample size calculations for the definitive RCT_x000D_
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Dissemination will be through 5 professional publications, social media, a website & patient newsletters & at relevant conferences.

Research Activity Codes: 7.3 MANAGEMENT AND DECISION MAKING
Health Categories: RENAL AND UROGENITAL;SKIN