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

Abstract

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: 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: 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: ACTRN12619000763145p.

Keywords: Fidelity; Medical; Pressure injury; Pressure ulcer; Process evaluation; Prophylactic dressings; Protocol; Randomised controlled trial; Sacral; Surgical.