PREVENTion and treatment of incontinence-associated dermatitis through a codesigned manual (PREVENT-IAD): a study protocol for a feasibility cluster randomised controlled trial with a nested process evaluation

Sue Woodward, Tanya Graham*, Sangeeta Sooriah, Dimitri Beeckman, Chris Chatterton, Mandy Fader, Francesca Fiorentino, Joanne M. Fitzpatrick, Ruth Harris, Jan Kottner, Christine Norton, Peter Worsley

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

INTRODUCTION: Incontinence is commonly experienced by adults who receive care support in a residential facility or in their own home. These individuals are at risk of developing incontinence-associated dermatitis (IAD), which is caused by prolonged and repeated exposure of the skin to urine or faeces. An IAD manual was developed providing an evidence-based clinical algorithm and an e-learning training programme for the prevention and treatment of IAD. The aim of the study is to establish the feasibility of conducting a definitive trial to examine the clinical and cost-effectiveness of the IAD manual. The objectives are to assess recruitment and attrition rates, acceptability of the IAD manual and intervention fidelity.

METHODS AND ANALYSIS: A feasibility cluster randomised controlled trial will be conducted in residential nursing homes and in the homes of people receiving formal care support in London and Hampshire, England. A total of six clusters including n=248 participants who are incontinent of urine, or faeces will be included. At each intervention site, care staff will be trained to implement the IAD manual over a 6-month period. Quantitative outcomes include IAD incidence and severity, IAD-related pain, satisfaction with care and mental health. A qualitative evaluation of care staff and care receivers' experiences of participation will be conducted. Rates and proportions of each feasibility outcome will be described informing the sample size estimation for a definitive cluster randomised controlled trial. A thematic analysis of the qualitative data will be guided by a logic model detailing potential factors impacting on both the study methodology and adoption of the IAD manual into routine care.

ETHICS AND DISSEMINATION: The study received the approval of the Queens Square Ethics Committee Health Research Authority 23/LO/036, (Project ID 296167). Results will be disseminated through peer-reviewed open-access journals and international conferences TRIAL REGISTRATION NUMBER: ISRCTN70866724.

Original languageEnglish
Article numbere092338
JournalBMJ Open
Volume14
Issue number12
DOIs
Publication statusPublished - 23 Dec 2024

Keywords

  • Humans
  • Urinary Incontinence/therapy
  • Feasibility Studies
  • Dermatitis/prevention & control
  • Fecal Incontinence/therapy
  • Randomized Controlled Trials as Topic
  • Nursing Homes
  • England

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