title: 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.
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.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Royal Brisbane and Women's Hospital, Australia; NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia. Electronic address: joan.webster@health.qld.gov.au.
authors.forename: Joan
authors.initials: J
authors.lastname: Webster
authors.affiliation: NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia; Alfred Health, Australia; School of Nursing and Midwifery, Deakin University, Australia.
authors.forename: Tracey
authors.initials: T
authors.lastname: Bucknall
authors.affiliation: NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia; School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Australia.
authors.forename: Marianne
authors.initials: M
authors.lastname: Wallis
authors.affiliation: St Vincent's Health Australia, Sydney, Australia; School of Nursing, Midwifery and Paramedicine, Australian Catholic University, Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McInnes
authors.affiliation: NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia; Menzies Health Institute Queensland, Griffith University, Australia.
authors.forename: Shelley
authors.initials: S
authors.lastname: Roberts
authors.affiliation: NHMRC Centre of Research Excellence in Nursing, Griffith University, Australia; Menzies Health Institute Queensland, Griffith University, Australia.
authors.forename: Wendy
authors.initials: W
authors.lastname: Chaboyer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D003668:Pressure Ulcer / Q000517:prevention & control*; D012189:Retrospective Studies
keywords: Follow-up studies; Nursing; Outcome and Process Assessment (Health Care); Pressure ulcer