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Does participating in a clinical trial affect subsequent nursing management? Post-trial care for participants recruited to the INTACT pressure ulcer prevention trial : A follow-up study

Webster, Joan
; 
Bucknall, Tracey
; 
Wallis, Marianne
; 
McInnes, Elizabeth
; 
Roberts, Shelley
; 
Chaboyer, Wendy
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Author
Webster, Joan
Bucknall, Tracey
Wallis, Marianne
McInnes, Elizabeth
Roberts, Shelley
Chaboyer, Wendy
Abstract
Background: Participation in a clinical trial is believed to benefit patients but little is known about the post-trial effects on routine hospital-based care. Objectives: To describe (1) hospital-based, pressure ulcer care-processes after patients were discharged from a pressure ulcer prevention, cluster randomised controlled trial; and (2) to investigate if the trial intervention had any impact on subsequent hospital-based care. Methods: We conducted a retrospective analysis of 133 trial participants who developed a pressure ulcer during the clinical trial. We compared outcomes and care processes between participants who received the pressure ulcer prevention intervention and those in the usual care, control group. We also compared care processes according to the pressure ulcer stage. Results: A repositioning schedule was reported for 19 (14.3%) patients; 33 (24.8%) had a dressing applied to the pressure ulcer; 17 (12.8) patients were assessed by a wound care team; and 20 (15.0%) were seen by an occupational therapist. Patients in the trial’s intervention group were more likely to have the presence of a pressure ulcer documented in their chart (odds ratio (OR) 8.18, 95% confidence intervals (CI) 3.64–18.36); to be referred to an occupational therapist OR 0.92 (95% CI 0.07; 0.54); to receive a pressure relieving device OR 0.31 (95% CI 0.14; 0.69); or a pressure relieving mattress OR 0.44 (95% CI 0.20; 0.96). Participants with Stage 2 or unstageable ulcers were more likely than others to have dressings applied to their wounds (p = < 0.001) and to be referred to an occupational therapist for protective devices (p = 0.022). Conclusion: Participants in the intervention group of a clinical trial were more likely to receive additional post trial care and improved documentation compared with those in the control group but documentation of pressure ulcer status and care is poor.
Keywords
follow-up studies, pressure ulcer, nursing, outcome and process assessment (health care)
Date
2017
Type
Journal article
Journal
International Journal of Nursing Studies
Book
Volume
71
Issue
Page Range
34-38
Article Number
ACU Department
Nursing Research Institute
Faculty of Health Sciences
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Nursing Research Institute
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URI
https://hdl.handle.net/20.500.14802/17554
Relation URI
DOI
10.1016/j.ijnurstu.2017.02.022
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Open Access Status
Published as green open access
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Controlled
Controlled
Notes
This record includes an accepted manuscript. © 2017. This manuscript version is made available under the CC-BY-NC-ND 4.0 license (http://creativecommons.org/licenses/by-nc-nd/4.0/)