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

Sladdin, Ishtar; Walker, Rachel; Chaboyer, Wendy; Cooke, Marie; Whitty, Jennifer A.; Thalib, Lukman; Latimer, Sharon; Campbell, Jill; Gillespie, Brigid Mary

doi:10.1016/j.jtv.2021.11.003

Cited by 3 publications

(6 citation statements)

References 22 publications

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“…As part of the process evaluation that is undertaken alongside the clinical trial [ 16 ], it is important that we are able to determine the proportion of eligible patients who refused to participate and describe the demographic characteristics of both eligible patients who participated and those who do not (i.e. non-participants).…”

Section: Methods: Participants Interventions and Outcomesmentioning

confidence: 99%

“…In the latter part of the trial, a subsample of patients from the intervention group and nursing staff will be purposively selected to reflect a range of demographic and clinical factors as part of the process evaluation [ 16 ]. Nursing staff will be invited to participate following an informed consent process.…”

Section: Methods: Participants Interventions and Outcomesmentioning

confidence: 99%

“…As part of the process evaluation, where a patient is unable to provide information for self-report data (e.g. Patient Participation in Pressure Injury Prevention Scale, assessment of satisfaction and comfort), the ResN documents the reason [ 16 ]. These data are considered “missing” data for the purpose of analyses, but the reason and proportion of participants who do not have these data due to cognitive impairment, for example, will be reported in reports/publications.…”

Section: Data Collection and Managementmentioning

confidence: 99%

“…Process evaluation data will also be collected, to evaluate contextual factors (e.g. patient-, provider-, and system-level factors) that may have moderated the effect of an intervention [ 16 ].…”

Section: Introductionmentioning

confidence: 99%

“…Process evaluations are particularly important for multi-site trials where it is necessary to determine whether interventions are implemented and received consistently across sites and to understand differences between them [ 17 ]. They also provide detailed documentation to enable replication, and information regarding the mechanism of action for significant or non-significant effects, thereby enhancing an intervention’s validity [ 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

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EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial

Walker

Chaboyer

Cooke

et al. 2023

Trials

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Background Prophylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is still emerging. This trial aims to determine the clinical and cost-effectiveness of a prophylactic silicone foam border dressing in preventing sacral pressure injuries in medical-surgical patients. Methods This is a multicentre, pragmatic, parallel group, randomised controlled trial. A sample size of 1320 was calculated to have >90% power to detect a 5% difference in the primary outcome at an alpha of 0.05. Adult patients admitted to participating medical-surgical wards are screened for eligibility: ≥18 years, admitted to hospital within the previous 36 h, expected length of stay of ≥24 h, and assessed high risk for hospital-acquired pressure injury. Consenting participants are randomly allocated to either prophylactic silicone foam dressing intervention or usual care without any dressing as the control group via a web-based randomisation service independent of the trial. Patients are enrolled across three Australian hospitals. The primary outcome is the cumulative incidence of patients who develop a sacral pressure injury. Secondary outcomes include the time to sacral pressure injury, incidence of severity (stage) of sacral pressure injury, cost-effectiveness of dressings, and process evaluation. Participant outcomes are assessed daily for up to 14 days by blinded independent outcome assessors using de-identified, digitally modified sacral photographs. Those who develop a sacral pressure injury are followed for an additional 14 days to estimate costs of pressure injury treatment. Analysis of clinical outcomes will be based on intention-to-treat, per-protocol, and sensitivity analyses. Discussion This trial aims to provide definitive evidence on the effect prophylactic dressings have on the development of hospital-acquired sacral pressure injuries in medical-surgical patients. A parallel economic evaluation of pressure injury prevention and treatment will enable evidence-informed decisions and policy. The inclusion of a process evaluation will help to explain the contextual factors that may have a bearing on trial results including the acceptability of the dressings to patients and staff. The trial commenced 5 March 2020 and has been significantly delayed due to COVID-19. Trial registration ANZCTR ACTRN12619000763145. Prospectively registered on 22 May 2019

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Section: Methods: Participants Interventions and Outcomesmentioning

confidence: 99%

Section: Methods: Participants Interventions and Outcomesmentioning

confidence: 99%

Section: Data Collection and Managementmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial

Walker

Chaboyer

Cooke

et al. 2023

Trials

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Dressings and topical agents for preventing pressure ulcers

Patton,

Moore,

Boland

et al. 2024

Cochrane Database of Systematic Reviews

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Background Pressure ulcers occur when people cannot reposition themselves to relieve pressure over bony prominences. They are difficult to heal, costly, and reduce quality of life. Dressings and topical agents (lotions, creams, and oils) for pressure ulcer prevention are widely used. However, their effectiveness is unclear. This is the third update of this review. Objectives To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age without existing pressure ulcers, but at risk of developing one, in any healthcare setting. Search methods We used the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, two other databases, and two trial registers, together with reference checking, citation searching, and contact with study authors to identify the studies that are included in the review. The latest search date was November 2022. We imposed no restrictions on language, publication date, or setting. Selection criteria We included randomised controlled trials that enroled people at risk of developing a pressure ulcer. Data collection and analysis We used standard Cochrane methodological procedures. Main results In this update, we added 33 new studies, resulting in a total of 51 trials (13,303 participants). Of these, 31 studies involved dressings, 16 topical agents, and four included both dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence. Dressings Pressure ulcer incidence We made a total of 13 comparisons with 9027 participants. We present seven prioritised comparisons in the summary of findings (SoF) tables, as follows: silicone foam dressing versus no dressing (18 trials, 5903 participants; risk ratio (RR) 0.50, 95% confidence interval (CI) 0.33 to 0.77); foam dressing versus film dressing (3 trials, 569 participants; RR 0.72, 95% CI 0.20 to 2.67); hydrocellular foam dressing versus hydrocolloid dressing (1 trial, 80 participants; RR not estimable); silicone foam dressing type 1 versus silicone foam dressing type 2 (2 trials, 376 participants; RR 0.80, 95% CI 0.56 to 1.15); foam dressing versus fatty acid (2 trials, 300 participants; RR 1.67, 95% CI 0.49 to 5.72); polyurethane film versus hydrocolloid dressing (1 trial, 160 participants; RR 0.58, 95% CI 0.24 to 1.41); and hydrocolloid dressing versus no dressing (2 trials, 230 participants; RR 0.60, 95% CI 0.46 to 0.78). All low or very low‐certainty evidence. The evidence is very uncertain about the effect of dressings on pressure ulcer development. Pressure ulcer stage Three comparisons reported pressure ulcer (PU) stage. Silicone foam dressing versus no dressing: PU stage 1 (8 trials, 1823 participants; RR 0.32, 95% CI 0.13 to 0.79); PU stage 2 (10 trials, 2873 participants; RR 0.47, 95% CI 0.30 to 0.73); PU...

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EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: The EEPOC Trial

Walker

Chaboyer

Cooke

et al. 2022

Preprint

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Background Prophylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is still emerging. This trial aims to determine the clinical and cost-effectiveness of a prophylactic silicone foam border dressing in preventing sacral pressure injuries in medical-surgical patients. Methods This is a multicentre, pragmatic, parallel group, randomised controlled trial. A sample size of 1,320 was calculated to have > 90% power to detect a 5% difference in the primary outcome at an alpha of 0.05. Adult patients admitted to participating medical-surgical wards are screened for eligibility: ≥18 years; admitted to hospital within the previous 36 hours; expected length of stay of ≥ 24 hours and assessed high risk for hospital acquired pressure injury. Consenting participants are randomly allocated to either prophylactic silicone foam dressing intervention or usual care without any dressing as the control group via a web-based randomisation service independent of the trial. Patients are enrolled across three Australian hospitals. The primary outcome is the cumulative incidence of patients who develop a sacral pressure injury. Secondary outcomes include time to sacral pressure injury, incidence of severity (stage) of sacral pressure injury, cost-effectiveness of dressings, and process evaluation. Participant outcomes are assessed daily for up to 14 days by blinded independent outcome assessors using deidentified, digitally modified sacral photographs. Those who develop a sacral pressure injury are followed for an additional 14 days to estimate the costs of pressure injury treatment. Analysis of clinical outcomes will be based on intention-to-treat, per-protocol, and sensitivity analyses. Discussion This trial aims to provide definitive evidence on the effect prophylactic dressings have on development of hospital acquired sacral pressure injuries in medical-surgical patients. A parallel economic evaluation of pressure injury prevention and treatment will enable evidence-informed decisions and policy. The inclusion of a process evaluation will help to explain the contextual factors that may have a bearing on the results of the trial including acceptability of the dressings to patients and staff. The trial commenced 5 March 2020 but has been significantly delayed due to COVID-19. Trial registration: ANZCTR, prospectively registered 22 May 2019: ACTRN12619000763145

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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

Cited by 3 publications

References 22 publications

EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial

EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial

Dressings and topical agents for preventing pressure ulcers

EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: The EEPOC Trial

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