Process evaluation of an intervention to test the effectiveness of foam border dressings in preventing hospital-acquired sacral pressure injuries (the EEPOC trial): A protocol.
Fidelity
Medical
Pressure injury
Pressure ulcer
Process evaluation
Prophylactic dressings
Protocol
Randomised controlled trial
Sacral
Surgical
Journal
Journal of tissue viability
ISSN: 0965-206X
Titre abrégé: J Tissue Viability
Pays: England
ID NLM: 9306822
Informations de publication
Date de publication:
Feb 2022
Feb 2022
Historique:
received:
26
07
2021
revised:
07
11
2021
accepted:
11
11
2021
pubmed:
24
11
2021
medline:
16
2
2022
entrez:
23
11
2021
Statut:
ppublish
Résumé
Prophylactic foam border dressings are recommended for high-risk patients in addition to standard pressure injury prevention protocols despite limited high-quality evidence regarding their effectiveness. This protocol describes the process evaluation that will be undertaken alongside a multisite randomised controlled trial investigating the clinical and cost-effectiveness of these dressings in reducing hospital-acquired sacral pressure injury incidence. This theory informed parallel process evaluation using qualitative and quantitative methods will be undertaken in medical and surgical units. To evaluate fidelity, recruitment, reach, dose delivered and received, and context, process data will include: research nurses' self-reported adherence to intervention protocols; semi-structured interviews with participants and research nurses and focus groups with nursing staff; participants' satisfaction and comfort with the dressings and perceived level of participation in pressure injury prevention; and nurses' attitudes toward pressure injury prevention. The proportion of the target population recruited, participant characteristics, and adherence to intervention protocols will be reported using descriptive statistics. Chi square or t-tests will compare differences in demographic characteristics between groups, and non-participants, and multivariate modelling will investigate potential moderators on the trial outcomes. Analysis of qualitative data will be guided by the Framework Method, which provides a clear, systematic process for developing themes. This process evaluation will provide valuable insights into mechanisms of impact and contextual and moderating factors influencing trial outcomes. Process data will enhance reproducibility of the intervention and trustworthiness of findings, and inform clinicians, researchers, and policy makers about the extent to which foam border dressings can be feasibly implemented in clinical practice. ACTRN12619000763145p.
Sections du résumé
BACKGROUND
BACKGROUND
Prophylactic foam border dressings are recommended for high-risk patients in addition to standard pressure injury prevention protocols despite limited high-quality evidence regarding their effectiveness. This protocol describes the process evaluation that will be undertaken alongside a multisite randomised controlled trial investigating the clinical and cost-effectiveness of these dressings in reducing hospital-acquired sacral pressure injury incidence.
METHODS
METHODS
This theory informed parallel process evaluation using qualitative and quantitative methods will be undertaken in medical and surgical units. To evaluate fidelity, recruitment, reach, dose delivered and received, and context, process data will include: research nurses' self-reported adherence to intervention protocols; semi-structured interviews with participants and research nurses and focus groups with nursing staff; participants' satisfaction and comfort with the dressings and perceived level of participation in pressure injury prevention; and nurses' attitudes toward pressure injury prevention. The proportion of the target population recruited, participant characteristics, and adherence to intervention protocols will be reported using descriptive statistics. Chi square or t-tests will compare differences in demographic characteristics between groups, and non-participants, and multivariate modelling will investigate potential moderators on the trial outcomes. Analysis of qualitative data will be guided by the Framework Method, which provides a clear, systematic process for developing themes.
DISCUSSION
CONCLUSIONS
This process evaluation will provide valuable insights into mechanisms of impact and contextual and moderating factors influencing trial outcomes. Process data will enhance reproducibility of the intervention and trustworthiness of findings, and inform clinicians, researchers, and policy makers about the extent to which foam border dressings can be feasibly implemented in clinical practice.
TRIAL REGISTRATION
BACKGROUND
ACTRN12619000763145p.
Identifiants
pubmed: 34810060
pii: S0965-206X(21)00127-3
doi: 10.1016/j.jtv.2021.11.003
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Pagination
158-163Informations de copyright
Copyright © 2021 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.