Evidence map›Paper›PMID 28193242›Full record

Trial reportImplementation science : IS2017

Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study.

Shelley Roberts, Elizabeth McInnes, Tracey Bucknall, Marianne Wallis, Merrilyn Banks, Wendy Chaboyer

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Implementation science : IS, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
6.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Patient-centred clinical trial design.Nature reviews. Nephrology · 2022
    Review
  5. Article
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

Shelley RobertsNational Centre of Research Excellence in Nursing, Menzies Health Institute Queensland, Griffith University, Gold Coast Campus, Southport, QLD, 4222, Australia. s.roberts@griffith.edu.au.
Elizabeth McInnesNursing Research Institute, St Vincent's Health Australia (Sydney) and School of Nursing, Midwifery and Paramedicine, Australian Catholic University, North Sydney, NSW, 2060, Australia.
Tracey BucknallCentre for Quality and Patient Safety, School of Nursing and Midwifery, Deakin University, Geelong, VIC, 3220, Australia.
Marianne WallisSchool of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Locked Bag 4, Maroochydore, QLD, 4558, Australia.
Merrilyn BanksDepartment of Nutrition and Dietetics, Royal Brisbane and Women's Hospital, Herston, QLD, 4019, Australia.
Wendy ChaboyerNational Centre of Research Excellence in Nursing, Menzies Health Institute Queensland, Griffith University, Gold Coast Campus, Southport, QLD, 4222, Australia.
Griffith University · AUAustralian Catholic University · AUDeakin University · AURoyal Brisbane and Women's Hospital · AUUniversity of the Sunshine Coast · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. Our team developed and tested a complex intervention, a pressure ulcer prevention care bundle promoting patient participation in care, in a cluster-randomised trial. The UK Medical Research Council recommends process evaluation of complex interventions to provide insight into why they work or fail and how they might be improved. This study aimed to evaluate processes underpinning implementation of the intervention and explore end-users' perceptions of it, in order to give a deeper understanding of its effects.

methodsA pre-specified, mixed-methods process evaluation was conducted as an adjunct to the main trial, guided by a framework for process evaluation of cluster-randomised trials. Data was collected across eight Australian hospitals but mainly focused on the four intervention hospitals. Quantitative and qualitative data were collected across the evaluation domains: recruitment, reach, intervention delivery and response to intervention, at both cluster and individual patient level. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed using thematic analysis.

resultsIn the context of the main trial, which found a 42% reduction in risk of pressure ulcer with the intervention that was not significant after adjusting for clustering and covariates, this process evaluation provides important insights. Recruitment and reach among clusters and individuals was high, indicating that patients, nurses and hospitals are willing to engage with a pressure ulcer prevention care bundle. Of 799 intervention patients in the trial, 96.7% received the intervention, which took under 10 min to deliver. Patients and nurses accepted the care bundle, recognising benefits to it and describing how it enabled participation in pressure ulcer prevention (PUP) care.

conclusionsThis process evaluation found no major failures relating to implementation of the intervention. The care bundle was found to be easy to understand and deliver, and it reached a large proportion of the target population and was found to be acceptable to patients and nurses; therefore, it may be an effective way of engaging patients in their pressure ulcer prevention care and promoting evidence-based practise.

Indexed as

Cluster AnalysisHumansPatient Care BundlesPressure UlcerCare bundleCluster-randomised trialComplex interventionPatient participationPressure injury preventionPressure ulcer preventionProcess evaluation

Identifiers

PMID28193242
PMCPMC5307838
OpenAlexW2588490021

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.