Development and validation of the Pressure Injury after Hospital Admission (PIAHA) screening tool for early assessment of hospital-acquired pressure injuries: a multiphase multicentre study protocol in acute care settings

开发和验证入院后压力性损伤 (PIAHA) 筛查工具,用于早期评估医院获得性压力性损伤:一项在急性护理机构开展的多阶段多中心研究方案

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Abstract

INTRODUCTION: Early prediction of hospital-acquired pressure injuries (HAPIs) is crucial for delivering prompt therapeutic interventions and personalised preventive measures to hospitalised patients. However, existing pressure injury (PI) assessment tools often lack transparency, objectivity, comprehensiveness and reliability. This study protocol aims to identify risk factors, develop a screening tool (Pressure Injury after Hospital Admission - PIAHA), and conduct a two-step validation for the early prediction of PI after hospital admission. METHODS AND ANALYSIS: This multiphase, multicentre, sequential research design comprises five phases. The first phase involves an umbrella review to synthesise comprehensive information on PI risk factors in hospitalised patients from published review studies. The second phase will use conventional content analysis and qualitative interviews with national and international experts to identify context-specific predictors of HAPIs. The third phase will employ a three-round E-Delphi method to integrate findings and establish a structured list of potential predictors. In the fourth phase, a cross-sectional study will evaluate the predictive value of identified risk factors for HAPI development among hospitalised patients, contributing to the development of the PIAHA screening tool. The final phase consists of a two-step validation: (1) a cross-sectional comparison of the PIAHA tool against the gold standard and (2) a cluster randomised controlled trial to compare the effectiveness and cost-effectiveness of the novel 'IDEAL SKIIN CARES' prevention bundle, administered by trained wound specialist nurses, vs routine standard care. ETHICS AND DISSEMINATION: Ethical approval was granted by Baqiyatallah University of Medical Sciences (IR.BMSU.REC.1402.059) covering all study phases. Written informed consent will be obtained from participants or their legal representatives. The study follows the Declaration of Helsinki. Results will be disseminated via peer-reviewed publications, conferences, webinars, policy briefs and public engagement through social media, educational videos and podcasts. IMPLICATIONS FOR CLINICAL PRACTICE: The PIAHA tool promises to enhance early detection of HAPI risk, facilitating individualised prevention and optimising clinical resource allocation. Implementation of the IDEAL SKIIN CARES bundle may improve patient outcomes and reduce healthcare costs by standardising evidence-based preventive care. PROSPERO REGISTRATION NUMBER: CRD42024532133. TRIAL REGISTRATION NUMBER: NCT06369688.

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