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.

IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
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
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引用次数: 0

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.

通过共同设计手册(PREVENTion - iad)预防和治疗失禁相关性皮炎:一项具有嵌套过程评估的可行性聚类随机对照试验的研究方案。
导读:尿失禁是成人谁接受护理支持在住宅设施或在自己的家普遍经历。这些人有发生尿失禁相关性皮炎(IAD)的风险,这是由皮肤长期和反复暴露于尿液或粪便引起的。编写了一份IAD手册,为IAD的预防和治疗提供了循证临床算法和电子学习培训方案。这项研究的目的是确定进行一项最终试验的可行性,以审查内部审计手册的临床和成本效益。其目标是评估征聘和减员率、内部审计手册的可接受性和干预的保真度。方法与分析:可行性随机对照试验将在伦敦和英格兰汉普郡的养老院和接受正式护理支持的人的家中进行。共有6组包括n=248名尿失禁或粪便失禁的参与者将被纳入。在每个干预点,将对护理人员进行为期6个月的培训,以执行IAD手册。定量结果包括IAD的发生率和严重程度、IAD相关疼痛、护理满意度和心理健康。将对护理人员和接受护理者的参与经验进行定性评价。将描述每个可行性结果的比率和比例,为确定的集群随机对照试验提供样本量估计。对定性数据的专题分析将以一个逻辑模型为指导,该模型详细说明影响研究方法和将IAD手册纳入日常护理的潜在因素。伦理和传播:该研究获得皇后广场伦理委员会卫生研究管理局23/LO/036的批准,(项目ID 296167)。研究结果将通过同行评审的开放获取期刊和国际会议进行传播。试验注册号:ISRCTN70866724。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMJ Open
BMJ Open MEDICINE, GENERAL & INTERNAL-
CiteScore
4.40
自引率
3.40%
发文量
4510
审稿时长
2-3 weeks
期刊介绍: BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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