TY - JOUR
T1 - Does participating in a clinical trial affect subsequent nursing management? Post-trial care for participants recruited to the INTACT pressure ulcer prevention trial
T2 - A follow-up study
AU - Webster, Joan
AU - Bucknall, Tracey
AU - Wallis, Marianne
AU - McInnes, Elizabeth
AU - Roberts, Shelley
AU - Chaboyer, Wendy
PY - 2017/6/1
Y1 - 2017/6/1
N2 - 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.
AB - 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.
KW - Follow-up studies
KW - Nursing
KW - Outcome and Process Assessment (Health Care)
KW - Pressure ulcer
UR - http://www.scopus.com/inward/record.url?scp=85015020368&partnerID=8YFLogxK
U2 - 10.1016/j.ijnurstu.2017.02.022
DO - 10.1016/j.ijnurstu.2017.02.022
M3 - Article
AN - SCOPUS:85015020368
VL - 71
SP - 34
EP - 38
JO - International Journal of Nursing Studies
JF - International Journal of Nursing Studies
SN - 0020-7489
ER -