A realist evaluation of devices used for the prevention of heel pressure ulcers: An ethnographic study of clinical practice.

BACKGROUND: It is known that heel offloading devices are widely used in clinical practice for the prevention of heel pressure ulcers, even though there is a lack of robust, good quality evidence to inform their use. OBJECTIVE: To explore how and why heel offloading devices are used (or not used) and reasoning behind their use in population at high risk of developing heel pressure ulcers. METHODS: An ethnographic study was conducted as part of a realist evaluation in three orthopaedic wards in a large English hospital. Twelve observations took place, with 49 h and 35 min of patient care observed. A total of 32 patients were observed and 19 members of the nursing team were interviewed and in-depth interviews with the three ward managers were conducted. RESULTS: Although the focus of the study was on offloading devices, constant low pressure heel specific devices were also observed in use for pressure ulcer prevention, whilst offloading devices were perceived to be for higher risk patients or those already with a heel pressure ulcer. Nursing staff viewed leadership from the ward manager and the influence of the Tissue Viability Nurse Specialists as key mechanisms for the proactive use of devices. CONCLUSIONS: This study informs trial design as it has identified that a controlled clinical trial of both types of heel specific devices is required to inform evidence-based practice. Involving the ward managers and Tissue Viability Nurse Specialists during set up phase for clinical equipoise could improve recruitment. Tweetable abstract How, for whom, and in what circumstances do devices work to prevent heel pressure ulcers? Observations of clinical practice.

Offloading devices for the prevention of heel pressure ulcers: A realist evaluation.

BACKGROUND: Heel pressure ulcers can cause pain, reduce mobility, lead to longer hospital stays and in severe cases can lead to sepsis, amputation, and death. Offloading boots are marketed as heel pressure ulcer prevention devices, working by removing pressure to the heel, yet there is little good quality evidence about their clinical effectiveness. Given that evidence is not guiding use of these devices, this study aims to explore, how, when, and why these devices are used in hospital settings. OBJECTIVE: To explore how offloading devices are used to prevent heel pressure ulcers, for whom and in what circumstances. METHODS: A realist evaluation was undertaken to explore the contexts, mechanisms, and outcomes that might influence how offloading devices are implemented and used in clinical practice for the prevention of heel pressure ulcers in hospitals. Eight Tissue Viability Nurse Specialists from across the UK (England, Wales, and Northern Ireland) were interviewed. Questions sought to elicit whether, and in what ways, initial theories about the use of heel pressure ulcers fitted with interviewee's experiences. RESULTS: Thirteen initial theories were refined into three programme theories about how offloading devices are used by nurses 'proactively' to prevent heel pressure ulcers, 'reactively' to treat and minimise deterioration of early-stage pressure ulcers, and patient factors that influence how these devices are used. CONCLUSIONS: Offloading devices were used in clinical practice by all the interviewees. It was viewed that they were not suitable to be used by every patient, at every point in their inpatient journey, nor was it financially viable. However, the interviewees thought that identifying suitable 'at risk' patient groups that can maintain use of the devices could lead to proactive and cost-effective use of the devices. This understanding of the contexts and mechanisms that influence the effective use of offloading devices has implications for clinical practice and design of clinical trials of offloading devices. TWEETABLE ABSTRACT: How, for whom, and in what circumstances do offloading devices work to prevent heel pressure ulcers? Tissue viability nurses' perspectives.

Comparative effectiveness of heel-specific medical devices for the prevention of heel pressure ulcers: A systematic review.

BACKGROUND: Pressure ulcers (PUs) impact on patient's quality of life and are costly for healthcare providers. Heels are a particular concern due to specific risk factors. Relative effectiveness of medical devices, e.g., dressings, off-loading devices, heel cushioning devices, to reduce PU development is unknown. METHODS: Systematic review of the effectiveness of heel-specific medical devices for the prevention of heel PU (HPU)s. Database searches were performed from inception to June 2021 for RCTs. The primary outcome was incidence of new HPUs. Trials were assessed for risk of bias and data analysed with risk ratios, mean difference or hazard ratios as appropriate. RESULTS: Fifteen RCTs (4724 participants) were identified. Dressings, as constant low pressure (CLP) devices vs standard care: eight trials (very low quality) showed no-significant difference in effectiveness (RR 0.31, 95%CI 0.10 to 1.01). Off-loading devices vs standard care: three trials (low quality), showed significant reduction in development of Category≥1 HPUs (RR 0.20, 95%CI 0.05 to 0.80) two trials (medium quality), showed significant reduction in development of Category≥2 HPUs (RR 0.08, 95%CI 0.01 to 0.67). Comparisons between off-loading devices: two trials (low quality) showed no clear difference in HPU incidence. In a paediatric post-surgical population, one trial of off-loading device and one of a dressing (CLP device), both versus standard care, showed no clear difference in HPU incidence (RR 0.19 95%CI 0.02 to 1.55 and RR 0.89 95%CI 0.56 to 1.42 respectively). CONCLUSIONS: Off-loading devices may reduce HPU incidence, from low-quality evidence. There is insufficient evidence to suggest that dressings reduce HPU incidence.

Heel pressure ulcers: understanding why they develop and how to prevent them.

Because of its anatomical location and the fact that it has no muscle or fascia and little subcutaneous tissue, the heel is highly vulnerable to pressure damage and pressure ulcer development. Heel pressure ulcers are often severe and challenging to heal. Heel pressure ulcers are caused by factors such as pressure, shear and friction and the vulnerability of the heel to pressure damage is increased by immobility, the patient's skin status, the presence of previous pressure ulcers and/or scar tissue, and suboptimal tissue perfusion. The risk is also increased in patients with diabetes mellitus. The role of nurses includes assessing the risk and preventing the development of heel pressure ulcers. This article discusses the causes of, and risk factors for, heel pressure ulcers and describes techniques and devices that nurses can use to prevent them.

Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release.

BACKGROUND: Rates of common mental health problems are much higher in prison populations, but access to primary care mental health support falls short of community equivalence. Discontinuity of care on release is the norm and is further complicated by substance use and a range of social problems, e.g. homelessness. To address these problems, we worked with criminal justice, third sector social inclusion services, health services and people with lived experiences (peer researchers), to develop a complex collaborative care intervention aimed at supporting men with common mental health problems near to and following release from prison. This paper describes an external pilot trial to test the feasibility of a full randomised controlled trial. METHODS: Eligible individuals with 4 to 16 weeks left to serve were screened to assess for common mental health problems. Participants were then randomised at a ratio of 2:1 allocation to ENGAGER plus standard care (intervention) or standard care alone (treatment as usual). Participants were followed up at 1 and 3 months' post release. Success criteria for this pilot trial were to meet the recruitment target sample size of 60 participants, to follow up at least 50% of participants at 3 months' post release from prison, and to deliver the ENGAGER intervention. Estimates of recruitment and retention rates and 95% confidence intervals (CIs) are reported. Descriptive analyses included summaries (percentages or means) for participant demographics, and baseline characteristics are reported. RESULTS: Recruitment target was met with 60 participants randomised in 9 months. The average retention rates were 73% at 1 month [95% CI 61 to 83] and 47% at 3 months follow-up [95% CI 35 to 59]. Ninety percent of participants allocated to the intervention successfully engaged with a practitioner before release and 70% engaged following release. CONCLUSIONS: This pilot confirms the feasibility of conducting a randomised trial for prison leavers with common mental health problems. Based on this pilot study and some minor changes to the trial design and intervention, a full two-centre randomised trial assessing the clinical and cost-effectiveness of the ENGAGER intervention is currently underway.

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) photographic validation sub-study: study protocol for a randomised controlled trial.

BACKGROUND: PRESSURE 2 is a randomised evaluation of the clinical and cost effectiveness of two types of pressure relieving mattress for the prevention of pressure ulcers. The primary endpoint is the time to development of a Category ≥2 pressure ulcer. The current 'gold standard' for the identification of a Category ≥2 pressure ulcer is expert clinical assessment. Due to the appearance of the bed, it is not possible to achieve blinding of the endpoint. This therefore poses a risk to the internal validity of the study. A possible approach is to use photographs of skin sites, with central blinded review. However, there are practical and scientific concerns including whether patients would agree to photographs; the burden of data collection; the quality of photographs; the completeness of data; and how the use of photographs compares with the current 'gold standard'. This validation sub-study aims to assess and quantify potential bias in the reporting of the trial endpoint. METHODS/DESIGN: Patients will be specifically asked to consent to photographs being taken of their skin sites. Photographs will be taken at first observation or when patients develop a new Category ≥2 pressure ulcer (to assess over-reporting). A 10% random sample of patients will be identified for additional photographs of two skin sites (one torso and one limb) with and without a pressure ulcer (if present) by an independent assessor (to assess the potential for under-reporting). Staff will be trained to take photographs using a standardised camera and photographic technique. A 'grey scale' will be included in the photo to correct white balance. Photographs will be securely transferred for central review. Photographs will have white balance corrected, and the computer monitor will be calibrated prior to review. Analysis will include assessment of under- and over-reporting, acceptability of photography to patients, secure transfer of data, quality of and confidence in blinded photograph review and sensitivity analysis using photograph assessment of primary outcome. DISCUSSION: This study will use photographs to contribute to the primary outcome of the trial. It will inform our understanding of the acceptability of photography for prevention trials and the possibility of other uses of photographic data in clinical work and research. TRIAL REGISTRATION: ISRCTN, ISRCTN01151335 . Registered on 14 May 2013.

A retrospective analysis of the findings of pressure ulcer investigations in an acute trust in the UK.

UNLABELLED: The root cause analysis (RCA) process has been applied in this organisation since 2010 to investigate all severe pressure ulcers. A previous analysis of the findings from all RCAs completed during 2011-2013 identified actions for practice improvement. The current study reports the results of a further retrospective analysis following implementation of new evidence based investigation process. AIM: To analysis the findings from pressure ulcer investigations; compare the results to the previous study and reflect on the new investigation process. METHODS: Analysis was performed on data from completed RCAs during January-October 2014 to identify key themes and learning points. RESULTS: Thirty two pressure ulcer RCAs were included. Nutrition was the most common contributory factor, highlighting the issue of malnutrition in an acute care setting. The second most common contributory factor was medical conditions that lead to poor tissue perfusion. CONCLUSION: Severe pressure ulcers rarely occur due to a single root cause, but often due to a sequence of events. Patients frequently have multiple complex needs that increase their susceptibility, when this is in combination with a failure of care, a severe pressure ulcer can occur. The new investigation process had limited success in identifying organisational factors. Further work is needed to support staff in the investigation process.