Process evaluation of an intervention to test the effectiveness of foam border dressings in preventing hospital-acquired sacral pressure injuries (the EEPOC trial): A protocol |
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| Affiliation: | 1. NHMRC Centre for Research Excellence in Wiser Wounds, Menzies Health Institute Queensland, Griffith University, Queensland, Australia;2. Menzies Health Institute Queensland, Griffith University, Queensland, Australia;3. Princess Alexandra Hospital, Woolloongabba, Queensland, Australia;4. Health Economics Group, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK;5. Department of Biostatistics, Faculty of Medicine, Istanbul Ayd?n University, Istanbul, Turkey;6. Gold Coast University Hospital, Southport, Queensland, Australia;7. School of Nursing and Midwifery, Griffith University, Queensland, Australia;1. Radiology Service FGS Hospital de Sant Pau, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain;2. Department of Public Health, Mental Health and Maternity/Childhood Nursing, School of Nursing, Faculty of Medicine and Health Sciences, University of Barcelona, L’Hospitalet de Llobregat, Barcelona, Spain;3. Emergency Service of Hospital Dos de Maig, Barcelona, Spain;4. Department of Fundamental and Medical-Surgical Nursing, School of Nursing, Faculty of Medicine and Health Sciences, University of Barcelona, L’Hospitalet de Llobregat, Barcelona, Spain;5. Consolidated Research Group Quantitative Psychology (2017-SGR-269), Spain;6. Nursing and Health Doctorate Program at the University of Barcelona, Spain;1. Department of Neonatal Intensive Care Unit, The First Affiliated Hosptal of Wenzhou Medical University, Wenzhou, Zhejiang Province, China;2. Department of Neonatal Intensive Care Unit, The Second Affiliated Hospital and Yuying Children’ s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China;3. Department of Thoracic Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China;4. Department of Pediatric Respiratory, The Second Affiliated Hospital and Yuying Children’ s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China;5. Department of Clinical Skill Training, The Second Affiliated Hospital and Yuying Children’ s Hospital of Wenzhou Medical University, Zhejiang Province, China;6. School of Nursing, Wenzhou Medical University, Wenzhou, Zhejiang Province, China;1. Centre of Medical Device Evaluation – Handicap (CEDM-H), CHU Nîmes, Univ Montpellier, Nîmes, France;2. Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France;3. Centre Neurologique Mutualiste Propara, Montpellier, France;4. Epsylon laboratory, Montpellier, France;5. M2H laboratory, Euromov, Montpellier, France;1. Faculty of Health Science, Fundamentals of Nursing Department, Afyonkarahisar Health Science University, 03200, Afyonkarahisar, Turkey;2. Faculty of Health Science, Surgical Nursing Department, Afyonkarahisar Health Science University, 03200, Afyonkarahisar, Turkey;1. Faculty of Health, Education and Life Sciences, Birmingham City University, Birmingham, UK;2. School of Health, Science, and Wellbeing, Staffordshire University, Staffordshire, UK;3. University Hospital Coventry and Warwickshire NHS Trust, Coventry, UK;4. School of Pharmacy, Aston University, Birmingham, UK;5. Faculty of Business, Law and Social Sciences, Birmingham City University, Birmingham, UK;6. Health Education England, Birmingham, UK;7. NHS England and NHS Improvement, Birmingham, UK;1. School of Nursing, Hallym University, Hallymdaehak-gil, Chuncheon, Gangwon-do, 24252, South Korea;2. College of Nursing, Gachon University, 191 Hambakmoeiro, Yeonsu-Gu, Incheon, 21936, Republic of Korea |
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| Abstract: | BackgroundProphylactic foam border dressings are recommended for high-risk patients in addition to standard pressure injury prevention protocols despite limited high-quality evidence regarding their effectiveness. This protocol describes the process evaluation that will be undertaken alongside a multisite randomised controlled trial investigating the clinical and cost-effectiveness of these dressings in reducing hospital-acquired sacral pressure injury incidence.MethodsThis theory informed parallel process evaluation using qualitative and quantitative methods will be undertaken in medical and surgical units. To evaluate fidelity, recruitment, reach, dose delivered and received, and context, process data will include: research nurses' self-reported adherence to intervention protocols; semi-structured interviews with participants and research nurses and focus groups with nursing staff; participants' satisfaction and comfort with the dressings and perceived level of participation in pressure injury prevention; and nurses’ attitudes toward pressure injury prevention. The proportion of the target population recruited, participant characteristics, and adherence to intervention protocols will be reported using descriptive statistics. Chi square or t-tests will compare differences in demographic characteristics between groups, and non-participants, and multivariate modelling will investigate potential moderators on the trial outcomes. Analysis of qualitative data will be guided by the Framework Method, which provides a clear, systematic process for developing themes.DiscussionThis process evaluation will provide valuable insights into mechanisms of impact and contextual and moderating factors influencing trial outcomes. Process data will enhance reproducibility of the intervention and trustworthiness of findings, and inform clinicians, researchers, and policy makers about the extent to which foam border dressings can be feasibly implemented in clinical practice.Trial registrationACTRN12619000763145p. |
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| Keywords: | Pressure injury Pressure ulcer Process evaluation Fidelity Protocol Randomised controlled trial Prophylactic dressings Sacral Medical Surgical |
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