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


METHODS
Pragmatic cluster randomised trial.


METHODS
Eight tertiary referral hospitals with >200 beds each in three Australian states.


METHODS
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.
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.
Wendy
W
Chaboyer
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.
Tracey
T
Bucknall
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.
Joan
J
Webster
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.
Elizabeth
E
McInnes
NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia; Menzies Health Institute Queensland, Griffith University, Australia.
Brigid M
BM
Gillespie
Nutrition and Dietetics Department, Royal Brisbane and Women's Hospital, Herston, QLD 4006, Australia.
Merrilyn
M
Banks
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.
Jennifer A
JA
Whitty
Public Health Program, Department of Public Health, College of Health Sciences, Qatar University, Doha, Qatar.
Lukman
L
Thalib
NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia; Menzies Health Institute Queensland, Griffith University, Australia.
Shelley
S
Roberts
NHMRC Centre for Research Excellence in Nursing, Griffith University, Gold Coast Campus, QLD 4222, Australia; Menzies Health Institute Queensland, Griffith University, Australia.
Mandy
M
Tallott
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.
Nicky
N
Cullum
Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, University of the Sunshine Coast, Sunshine Coast, QLD 4556, Australia.
Marianne
M
Wallis
D000368:Aged; D001315:Australia; D005260:Female; D006801:Humans; D007049:Iatrogenic Disease / Q000517:prevention & control*; D008297:Male; D017063:Outcome Assessment, Health Care; D064872:Patient Care Bundles; D018802:Patient-Centered Care; D003668:Pressure Ulcer / Q000451:nursing / Q000517:prevention & control*; D011897:Random Allocation; D012107:Research Design
Care bundle; Cluster randomised trial; Nursing; Nursing interventions; Outcomes potentially sensitive to nursing; Patient indicators; Patient outcomes; Pressure ulcer; Pressure ulcer prevention