Wendy Chaboyer1, Tracey Bucknall2, Joan Webster3, Elizabeth McInnes4, Brigid M Gillespie5, Merrilyn Banks6, Jennifer A Whitty7, Lukman Thalib8, Shelley Roberts5, Mandy Tallott5, Nicky Cullum9, Marianne Wallis10. 1. NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia; Menzies Health Institute Queensland, Griffith University, Australia. Electronic address: w.chaboyer@griffith.edu.au. 2. NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia; Alfred Health, Melbourne, Australia; School of Nursing and Midwifery, Deakin University, Geelong, Australia. 3. NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia; Centre for Clinical Nursing, Royal Brisbane and Women's Hospital, Herston, QLD 4006, Australia. 4. Nursing Research Institute, Australian Catholic University and St. Vincent's Health Australia (Sydney), Darlinghurst, NSW 2010, Australia; School of Nursing, Midwifery and Paramedicine, Australian Catholic University, Australia. 5. NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia; Menzies Health Institute Queensland, Griffith University, Australia. 6. Nutrition and Dietetics Department, Royal Brisbane and Women's Hospital, Herston, QLD 4006, Australia. 7. NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia; School of Pharmacy, Faculty of Health and Behavioural Sciences, University of Queensland, Australia; Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, Norfolk, NR4 7JT, United Kingdom. 8. Public Health Program, Department of Public Health, College of Health Sciences, Qatar University, Doha, Qatar. 9. NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia; School of Nursing, Midwifery and Social Work, University of Manchester, Manchester M13 9PL, United Kingdom. 10. Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, University of the Sunshine Coast, Sunshine Coast, QLD 4556, Australia.
Abstract
BACKGROUND: Hospital-acquired pressure ulcers are a serious patient safety concern, associated with poor patient outcomes and high healthcare costs. They are also viewed as an indicator of nursing care quality. OBJECTIVE: To evaluate the effectiveness of a pressure ulcer prevention care bundle in preventing hospital-acquired pressure ulcers among at risk patients. DESIGN: Pragmatic cluster randomised trial. SETTING:Eight tertiary referral hospitals with >200 beds each in three Australian states. PARTICIPANTS: 1600 patients (200/hospital) were recruited. Patients were eligible if they were: ≥18 years old; at risk of pressure ulcer because of limited mobility; expected to stay in hospital ≥48h and able to read English. METHODS: Hospitals (clusters) were stratified in two groups by recent pressure ulcer rates and randomised within strata to either a pressure ulcer prevention care bundle or standard care. The care bundle was theoretically and empirically based on patient participation and clinical practice guidelines. It was multi-component, with three messages for patients' participation in pressure ulcer prevention care: keep moving; look after your skin; and eat a healthy diet. Training aids for patients included a DVD, brochure and poster. Nurses in intervention hospitals were trained in partnering with patients in their pressure ulcer prevention care. The statistician, recruiters, and outcome assessors were blinded to group allocation and interventionists blinded to the study hypotheses, tested at both the cluster and patient level. The primary outcome, incidence of hospital-acquired pressure ulcers, which applied to both the cluster and individual participant level, was measured by daily skin inspection. RESULTS: Four clusters were randomised to each group and 799 patients per group analysed. The intraclass correlation coefficient was 0.035. After adjusting for clustering and pre-specified covariates (age, pressure ulcer present at baseline, body mass index, reason for admission, residence and number of comorbidities on admission), the hazard ratio for new pressure ulcers developed (pressure ulcer prevention care bundle relative to standard care) was 0.58 (95% CI: 0.25, 1.33; p=0.198). No adverse events or harms were reported. CONCLUSIONS: Although the pressure ulcer prevention care bundle was associated with a large reduction in the hazard of ulceration, there was a high degree of uncertainty around this estimate and the difference was not statistically significant. Possible explanations for this non-significant finding include that the pressure ulcer prevention care bundle was effective but the sample size too small to detect this. Copyright Â
RCT Entities:
BACKGROUND: Hospital-acquired pressure ulcers are a serious patient safety concern, associated with poor patient outcomes and high healthcare costs. They are also viewed as an indicator of nursing care quality. OBJECTIVE: To evaluate the effectiveness of a pressure ulcer prevention care bundle in preventing hospital-acquired pressure ulcers among at risk patients. DESIGN: Pragmatic cluster randomised trial. SETTING: Eight tertiary referral hospitals with >200 beds each in three Australian states. PARTICIPANTS: 1600 patients (200/hospital) were recruited. Patients were eligible if they were: ≥18 years old; at risk of pressure ulcer because of limited mobility; expected to stay in hospital ≥48h and able to read English. METHODS: Hospitals (clusters) were stratified in two groups by recent pressure ulcer rates and randomised within strata to either a pressure ulcer prevention care bundle or standard care. The care bundle was theoretically and empirically based on patient participation and clinical practice guidelines. It was multi-component, with three messages for patients' participation in pressure ulcer prevention care: keep moving; look after your skin; and eat a healthy diet. Training aids for patients included a DVD, brochure and poster. Nurses in intervention hospitals were trained in partnering with patients in their pressure ulcer prevention care. The statistician, recruiters, and outcome assessors were blinded to group allocation and interventionists blinded to the study hypotheses, tested at both the cluster and patient level. The primary outcome, incidence of hospital-acquired pressure ulcers, which applied to both the cluster and individual participant level, was measured by daily skin inspection. RESULTS: Four clusters were randomised to each group and 799 patients per group analysed. The intraclass correlation coefficient was 0.035. After adjusting for clustering and pre-specified covariates (age, pressure ulcer present at baseline, body mass index, reason for admission, residence and number of comorbidities on admission), the hazard ratio for new pressure ulcers developed (pressure ulcer prevention care bundle relative to standard care) was 0.58 (95% CI: 0.25, 1.33; p=0.198). No adverse events or harms were reported. CONCLUSIONS: Although the pressure ulcer prevention care bundle was associated with a large reduction in the hazard of ulceration, there was a high degree of uncertainty around this estimate and the difference was not statistically significant. Possible explanations for this non-significant finding include that the pressure ulcer prevention care bundle was effective but the sample size too small to detect this. Copyright Â
Authors: Brecht Serraes; Ann Van Hecke; Hanne Van Tiggelen; Charlotte Anrys; Sofie Verhaeghe; Dimitri Beeckman Journal: Int Wound J Date: 2020-06-30 Impact factor: 3.315
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Authors: Brigid M Gillespie; Rachel M Walker; Sharon L Latimer; Lukman Thalib; Jennifer A Whitty; Elizabeth McInnes; Wendy P Chaboyer Journal: Cochrane Database Syst Rev Date: 2020-06-02