Title: WHITE-PRESSURE3: World Hip Trauma Evaluation - Pressure ulcer prevention 3; A randomised clinical trial assessing early heel specific adjunct devices for heel pressure ulcer prevention in people with a fractured hip.
Funder: Department of Health and Social Care

Abstract: WHAT IS THE PROBLEM?_x000D_ People with hip fracture (broken hip) can take a long time to recover and are vulnerable to a range of complications associated with their reduced mobility, including pressure ulcers._x000D_ _x000D_ Pressure ulcers are caused by sitting/lying in one position or being unable to move a part of the body. They cause pain, discomfort and distress to patients, leading to reduced quality of life and sometimes death. They range in seriousness: Category 1 is a reddened area, Category 2 is a blister/skin loss and Categories 3 and 4 are deep wounds._x000D_ _x000D_ People with a hip fracture are at high risk of heel pressure ulcer development due to difficulty moving their affected leg and use of the opposite heel when pushing themselves up/moving in bed. Also, factors which lead to hip fractures are also risks for pressure ulcer development for example frailty._x000D_ _x000D_ If pressure ulcers develop on the heel of a person with a hip fracture they cause added problems as they take a long time to heal (often months) reducing mobility, affecting the shoes they are able to wear and increasing their time to start walking again. _x000D_ _x000D_ WHAT ARE WE TRYING TO FIND OUT?_x000D_ The project is about the prevention of heel pressure ulcers in patients with hip fracture. _x000D_ _x000D_ WHAT WILL WE DO?_x000D_ Usual care for pressure ulcer prevention includes specialist mattresses, electric powered bedframes and repositioning in bed. This study will compare usual care alone with usual care plus one of two types of specialist heel equipment: _x000D_ a)heel off-loading devices ensuring no contact with the heel. They include foam troughs and boots which are applied to the legs_x000D_ b)low pressure devices which are softer than a mattress and so reduce the pressure at the heel. They include pads made of foam or gel and are laid on top of the bedsheet. _x000D_ _x000D_ Both types of specialist equipment are available for high risk patients in the NHS but are not routinely used for patients with hip fracture._x000D_ _x000D_ We will study 3102 patients with a hip fracture in 30 NHS hospitals. People taking part in the study will have a 1 in 3 chance of getting the off-loading device, the low pressure device or usual care as decided by a computer. To make the study results relevant to all NHS patients with hip fracture we will include patients who can provide consent themselves as well as patients who may be confused with the agreement of their next of kin. _x000D_ _x000D_ Patients who agree to take part in the study will have their heels assessed twice weekly until they leave hospital. The study will compare the number of patients who develop a heel pressure ulcer. At 4 months, we will ask the patients to complete a simple questionnaire by telephone, email or post to tell us about their recovery after leaving hospital. _x000D_ _x000D_ WHO ARE WE?_x000D_ The study team includes service users, surgeons, nurses, statisticians and a health economist, all with experience in hip fracture and/or pressure ulcer care/research. _x000D_ _x000D_ HOW HAVE PATIENTS HELPED DEVELOP THIS RESEARCH? _x000D_ The research question and study design has been co-produced with service users through established patient groups who inform and support hip fractures and pressure ulcer research. Two service user representatives have agreed to be part of the study team. _x000D_ _x000D_ HOW WILL WE TELL PEOPLE ABOUT WHAT WE FOUND OUT?_x000D_ We will tell service users and healthcare professionals through co-produced conference presentations, publications and social media. We will work with health care planners to ensure the results help shape future guidelines

Lay abstract: Patients admitted with a fractured hip are at risk of heel pressure ulcers (PU) which impact upon rehabilitation, recovery and independence. Whilst available in the NHS, the use of heel specific adjunct devices for heel PU prevention is not common, even in high-risk patient populations. _x000D_ _x000D_ AIM: to evaluate the clinical and cost-effectiveness of the use of early initiation of heel off-loading devices and constant low pressure devices for the prevention of Category 2 or higher heel PUs in hip fractures patients._x000D_ _x000D_ PRIMARY OBJECTIVE: To compare the incidence of new Category 2 or higher heel PUs from diagnosis of a hip fracture to index hospital discharge or 30 days which ever is soonest, between Standard Care plus early initiation of a Heel Off-loading Device, Standard Care plus early initiation of a CLP Device and Standard Care alone in patients with hip fracture. _x000D_ _x000D_ SECONDARY OBJECTIVES: will compare: 1. the incidence of new Category 1 heel PUs from randomisation to index hospital discharge or 30 days which ever is soonest between treatment groups in participants with intact skin at randomisation. 2. the overall incidence of new Category 1 or higher heel PUs from randomisation to index hospital discharge or 30 days which ever is soonest, between treatment groups in participants with intact skin at randomisation. 3. the progression of Category 1 or higher heel PUs to a higher Category from diagnosis of a hip fracture to index hospital discharge or 30 days which ever is soonest. 4. the proportion of resolved heel PUs at 4 months post-diagnosis of a hip fracture between treatment groups in participants with a Category 1 or higher heel PU at their final pre-discharge/30 day in-hospital skin status assessment. 5.To quantify the comparative cost effectiveness of the trial treatments up to 12 months post-randomisation._x000D_ _x000D_ _x000D_ DESIGN: pragmatic, multi-centre, randomised, 3 arm parallel group trial with embedded economic evaluation and internal pilot. _x000D_ _x000D_ SETTING: the trial will be embedded within the World Hip Trauma Evaluation (WHiTE) Platform in 30 pre-established WHiTE centres. Existing ethical and regulatory approvals for the platform enable efficiencies in study set-up. _x000D_ _x000D_ TARGET POPULATION: aged 60 years or over, admitted with a fracture of the hip within previous 48 hours. Excusions include pre-existing PU _x000D_ _x000D_ HEALTH TECHNOLOGIES: 3102 patients (1034 per group) will be randomised to: _x000D_ a) Standard of care plus adjunct heel off-loading devices which completely eliminate heel pressure including heel lift/suspension boots and off-loading wedges_x000D_ b) Standard of care plus adjunct constant low pressure device which distribute pressure over a larger surface area and so reduce the magnitude of the applied pressure including foam and gel pads and boots_x000D_ c) standard care alone which typically includes the provision of high specification foam mattresses or specialised air mattress; an electric profiling bed and; repositioning more frequently than 3 hourly. _x000D_ _x000D_ ANALYSES: analysis will be on an intention to treat basis with proportions of new Category 2 and higher heel PUs reported for each group and for the two principal comparisons: heel offloading versus standard care and CLP versus standard care, odds ratios and 97.5% confidence intervals will be reported. The economic assessment methods will adhere to the recommendations of the National Institute for Health and Care Excellence (NICE) Reference Case. _x000D_ _x000D_ TIMELINES AND ACCRUALS: Total 36 months – set-up 5months under WHiTE Platform, 6 month internal pilot in 6 centres, with 15 months full recruitment in 24 additional centres, 5 months follow-up and 5 months analysis/HTA monograph. _x000D_ _x000D_ IMPACT AND DISSEMINATION: the trial will provide definitive evidence on the effectiveness of adjunct devices for the prevention of heel PUs. We have developed a comprehensive publication, dissemination and impact plan to ensure implementation in clinical practice

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: MUSCULOSKELETAL;SKIN