The effect of a patient centred care bundle intervention on pressure ulcer incidence (INTACT): a cluster randomised trial

Chaboyer, Wendy, Bucknall, Tracey, Webster, Joan, McInnes, Elizabeth, Gillespie, Brigid M, Banks, Merrilyn, Whitty, Jennifer A, Thalib, Lukman, Roberts, Shelley, Tallott, Mandy, Cullum, Nicky and Wallis, Marianne (2016) The effect of a patient centred care bundle intervention on pressure ulcer incidence (INTACT): a cluster randomised trial. International Journal of Nursing Studies, 64. 63–71. ISSN 0020-7489

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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 ≥48 h 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.

Item Type: Article
Additional Information: Copyright 2016 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/
Uncontrolled Keywords: care bundle,cluster randomised trial,nursing,nursing interventions,patient indicators,patient outcomes,pressure ulcer,pressure ulcer prevention,outcomes potentially sensitive to nursing
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User: Pure Connector
Date Deposited: 28 Sep 2016 12:00
Last Modified: 18 Sep 2020 23:39
URI: https://ueaeprints.uea.ac.uk/id/eprint/60621
DOI: 10.1016/j.ijnurstu.2016.09.015

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