Trends in inpatient burden from pressure injuries in the United States: Cross-sectional study National Inpatient Sample 2009-2019.

Pressure injuries are a significant comorbidity and lead to increased overall healthcare costs. Several European and global studies have assessed the burden of pressure injuries; however, no comprehensive analysis has been completed in the United States. In this study, we investigated the trends in the burden of pressure injuries among hospitalised adults in the United States from 2009 to 2019, stratified by sociodemographic subgroups. The length of admission, total cost of hospitalisation, and sociodemographic data was extracted from the National Inpatient Sample provided by the Healthcare Cost and Utilisation Project, Agency for Healthcare Research and Quality. Overall, the annual prevalence of pressure injuries and annual mean hospitalisation cost increased ($69,499.29 to $102,939.14), while annual mean length of stay decreased (11.14-9.90 days). Among all races, minority groups had higher average cost and length of hospitalisation. Our findings suggest that while the length of hospitalisation is decreasing, hospital costs and prevalence are rising. In addition, differing trends among racial groups exist with decreasing prevalence in White patients. Further studies and targeted interventions are needed to address these differences, as well as discrepancies in racial groups.

Improving the Care and Cost of Treating Community-Acquired Stage 3 and 4 Decubitus Ulcers.

INTRODUCTION: The healthcare costs for treatment of community-acquired decubitus ulcers accounts for $11.6 billion in the United States annually. Patients with stage 3 and 4 decubitus ulcers are often treated inefficiently prior to reconstructive surgery while physicians attempt to optimize their condition (debridement, fecal/urinary diversion, physical therapy, nutrition, and obtaining durable medical goods). We hypothesized that hospital costs for inpatient optimization of decubitus ulcers would significantly differ from outpatient optimization costs, resulting in significant financial losses to the hospital and that transitioning optimization to an outpatient setting could reduce both total and hospital expenditures. In this study, we analyzed and compared the financial expenditures of optimizing patients with decubitus ulcers in an inpatient setting versus maximizing outpatient utilization of resources prior to reconstruction. METHODS: Encounters of patients with stage 3 or 4 decubitus ulcers over a 5-year period were investigated. These encounters were divided into two groups: Group 1 included patients who were optimized totally inpatient prior to reconstructive surgery; group 2 included patients who were mostly optimized in an outpatient setting and this encounter was a planned admission for their reconstructive surgery. Demographics, comorbidities, paralysis status, and insurance carriers were collected for all patients. Financial charges and reimbursements were compared among the groups. RESULTS: Forty-five encounters met criteria for inclusion. Group 1's average hospital charges were $500,917, while group 2's charges were $134,419. The cost of outpatient therapeutic items for patient optimization prior to wound closure was estimated to be $10,202 monthly. When including an additional debridement admission for group 2 patients (average of $108,031), the maximal charges for total care was $252,652, and hospital reimbursements were similar between group 1 and group 2 ($65,401 vs $50,860 respectively). CONCLUSIONS: The data derived from this investigation strongly suggests that optimizing patients in an outpatient setting prior to decubitus wound closure versus managing the patients totally on an inpatient basis will significantly reduce hospital charges, and hence costs, while minimally affecting reimbursements to the hospital.

The economic impact of pressure ulcers among patients in intensive care units. A systematic review.

BACKGROUND: The incidence and prevalence of pressure ulcers in critically ill patients in intensive care units (ICUs) remain high, despite the wealth of knowledge on appropriate prevention strategies currently available. METHODS: The primary objective of this systematic review was to examine the economic impact of pressure ulcers (PU) among adult intensive care patients. A systematic review was undertaken, and the following databases were searched; Medline, Embase, CINAHL, and The Cochrane Library. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was used to formulate the review. Quality appraisal was undertaken using the Consensus on Health Economic Criteria (CHEC)-list. Data were extracted using a pre-designed extraction tool, and a narrative analysis was undertaken. RESULTS: Seven studies met the inclusion criteria. Five reported costs associated with the prevention of pressure ulcers and three explored costs of treatment strategies. Four main PU prevention cost items were identified: support surfaces, dressing materials, staff costs, and costs associated with mobilisation. Seven main PU treatment cost items were reported: dressing materials, support surfaces, drugs, surgery, lab tests, imaging, additional stays and nursing care. The overall validities of the studies varied between 37 and 79%, meaning that there is potential for bias within all the included studies. CONCLUSION: There was a significant difference in the cost of PU prevention and treatment strategies between studies. This is problematic as it becomes difficult to accurately evaluate costs from the existing literature, thereby inhibiting the usefulness of the data to inform practice. Given the methodological heterogeneity among studies, future studies in this area are needed and these should use specific methodological guidelines to generate high-quality health economic studies.

Pressure Injury.

BACKGROUND: Pressure injury is seen across all healthcare settings and affects people of any age and health condition. It imposes a significant burden, with annual costs of up to $17.8 billion in the United States alone. Despite considerable resources it exhausts, the disease remains very prevalent, and the incidence is on the rise. This is in part due to aging population, growing number of nursing home residents, poorly understood biology, and dismal track record of clinical research in this field. METHODS: In our Review Article, we discuss the disease pathophysiology, clinical manifestation, evidence based recommendations for risk assessment, prevention and timely management, existing challenges, and directions to improve research on the field. This article encompasses dedicated sections on the full spectrum of the pressure related pathologies including "conventional pressure ulcers", "medical device related pressure injuries", "pressure injuries in mucosal membranes", "pressure injuries in pediatric population", "pressure injury at end of life", and the "role of pressure in pathogenesis of diabetic foot ulcers".

A multilayer polyurethane foam dressing for pressure ulcer prevention in older hip fracture patients: an economic evaluation.

OBJECTIVE: Hospital-acquired pressure ulcers (PU) have a substantial negative impact on patients and continue to impose a cost burden on hospital providers. Since the incidence of fragility fracture is growing, driven by the increase in the older population, it is expected that the overall incidence of associated complications will also increase accordingly. The aim of this economic evaluation was to determine whether the use of a multilayer, silicone-adhesive polyurethane foam dressing (ALLEVYN LIFE, Smith & Nephew, UK) alongside standard prevention (SP) for the prevention of PUs in older patients with hip fractures is a cost-effective strategy, compared with SP alone. METHOD: A decision-analytic model was constructed to determine the incremental cost and effectiveness of the foam dressing strategy from the perspectives of the Italian and US hospital systems. We also performed one-way and probabilistic sensitivity analyses. RESULTS: The foam dressing intervention was found to be cost saving and more effective than SP in both Italy and the US. Switching to foam dressing and standard prevention would result in an expected cost saving of €733 per patient in Italy and $840 per patient in the US, reducing the per-patient cost of treating PUs by 37-69% and 36-68%, respectively. The one-way and probabilistic sensitivity analyses demonstrate that the strategy remains dominant over a range of values of the input variables. CONCLUSION: The foam dressing intervention is likely to be a cost-effective strategy compared with standard prevention alone.

Prevention of pressure ulcers among individuals cared for in the prone position: lessons for the COVID-19 emergency.

OBJECTIVE: Pressure ulcers (PUs) involve the destruction of skin and underlying tissue due to prolonged pressure and shear forces. These ulcers are painful and significantly reduce a person's quality of life. PUs are also expensive to manage and impact negatively on the achievement of cost-effective, efficient care delivery. METHOD: Prone positioning is a postural therapy that aims to enhance respiratory function through increasing oxygenation levels. In contemporary clinical practice, ventilation in the prone position is indicated for patients with severe acute respiratory distress syndrome. However, despite its advantages in terms of respiratory function, several studies have examined complications of prone position ventilation and have identified PUs (facial PUs as well as PUs on other weight-bearing areas of the body) as a frequent complication in patients who are already in a precarious medical situation. International data suggest that up to 57% of patients nursed in the prone position develop a PU. The aim of this clinical review is to identify and review evidence-based recommendations developed to facilitate the selection and application of preventive interventions aimed at reducing PU development in patients ventilated in the prone position. Given the current COVID-19 crisis, this review is timely as intensive care unit (ICU) patients with COVID-19 require ventilation in the prone position at a level that is disproportionate to the general intensive care population. Up to 28% of patients admitted to the ICU with confirmed infection due to severe COVID-19 are cared for in the prone position. The scope of this review is limited to adult individuals only. RESULTS: The skin assessment should be undertaken before proning and following positioning the patient back into the supine position. Although it is essential to keep the skin clean and moisturised, using pH-balanced cleansers, there is inconsistency in terms of the evidence to support the type of moisturiser. Use of positioning devices in addition to repositioning is recommended to offload pressure points on the face and body. Further, using dressings such as hydrocolloids, transparent film and silicone may be of benefit in decreasing facial skin breakdown. CONCLUSION: Given the importance of PU prevention in this cohort of patients, adopting a focused prevention strategy, including skin assessment and care, offloading and pressure redistribution, and dressings for prevention may contribute to a reduction in the incidence and prevalence of these largely preventable wounds.

Blending Evidence-Based Practice and Lean Six Sigma Methodology to Reduce Hospital-Acquired Pressure Injuries in a Progressive Care Unit.

BACKGROUND: Hospital-acquired pressure injuries (HAPIs) continue to challenge acute care facilities. Best practice to reduce HAPI includes assessment, documentation, positioning, and treatment. LOCAL PROBLEM: In spite of using evidence-based practices, the hospital's gastrointestinal/genitourinary progressive care unit had more HAPIs each month than the other units in the hospital. METHODS: A combination of Lean Six Sigma and evidence-based practice was used to decrease HAPIs. INTERVENTIONS: The T program (turn, touch, and tidy) was developed to address the areas of concern identified in the root cause analysis. RESULTS: HAPIs were reduced from 22 in the previous 2 quarters to zero for 3 consecutive quarters with a cost avoidance to $379 767. CONCLUSIONS: The successful implementation of the T program was the result of blending Lean Six Sigma and evidence-based practice.

Differences in Length of Stay and Costs Between Comparable Hospitalizations of Patients With Spina Bifida With or Without Pressure Injuries.

OBJECTIVE: To estimate differences in the length of stay and costs for comparable hospitalizations of patients with spina bifida (SB) with and without pressure injuries. DESIGN: Retrospective, cross-sectional, observational study. SETTING: Nationwide Inpatient Sample from years 2010-2014. PARTICIPANTS: Hospitalizations of patients with SB (N=7776). Hospitalizations among patients with SB and pressure injuries (n=3888) were matched to hospitalizations among patients with SB but without pressure injuries (n=3888). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Differences in length of stay and total costs between the 2 groups. RESULTS: After successful matching, multivariate modeling of costs and length of stay on matched sample showed that hospitalizations with pressure injuries had an increased 1.2 inpatient days and excess average costs of $1182 in 2014 dollars. CONCLUSIONS: The estimated average cost of hospitalization increased by 10%, and the estimated average length of stay increased by 24% in the presence of pressure injuries among hospitalized patients with SB, compared with their peers without these injuries. These results highlight the substantial morbidity associated with pressure injuries, which are potentially preventable before or during hospitalizations among persons with SB.

Concentration of Costs Among High Utilizers of Health Care Services Over the First 10 Years After Spinal Cord Injury Rehabilitation: A Population-based Study.

OBJECTIVE: The purpose of this study was to (1) categorize individuals into high, medium, and low utilizers of health care services over a 10-year period after the onset of spinal cord injury (SCI) and (2) identify the pattern of causes of hospitalizations and the characteristics associated with high utilization. DESIGN: Retrospective analysis of self-report assessment linked to administrative data. SETTING: Data were collected from participants living in and utilizing hospitals in the state of South Carolina. PARTICIPANTS: Adult participants with traumatic SCI were identified through a state SCI Surveillance System Registry, a population-based system capturing all incident cases treated in nonfederal facilities. Among 963 participants who completed self-report assessments, we matched those with a minimum of 10 years of administrative records for a final sample of 303 participants (N=303). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Costs related to health care utilization for emergency department visits and hospitalizations, as measured operationally by hospital charges at full and established rates; causes of hospitalizations RESULTS: Over two-thirds of the total $49.4 million in charges for hospitalization over the 10-year timeframe (69%) occurred among 16.5% of the cohort (high utilizers), whereas those in the low utilizer group comprised 53% of the cohort with only 3.5% of the charges. The primary diagnoses were septicemia (50%), other urinary tract disorder (48%), mechanical complication of device, implant, or graft (48%), and chronic ulcer of skin (40%). Primary diagnoses were frequently accompanied by secondary diagnoses, indicating the co-occurrence of multiple secondary health conditions. High utilizers were more likely to be male, minority, have a severe SCI, have reported frequent pressure ulcers and have income of less than $35,000 per year. CONCLUSIONS: The high cost of chronic health care utilization over a 10-year timeframe was concentrated in a relatively small portion of the SCI population who have survived more than a decade after SCI onset.

Incidence of pressure ulcers in intensive care units and direct costs of treatment: Evidence from Iran.

BACKGROUND AND OBJECTIVE: Pressure ulcer (PU) is one of the important and frequent complications of hospitalization, associated with high treatment costs. The present study was conducted to determine the incidence of PU and its direct treatment costs for patients in intensive care unit (ICU) in Iran. MATERIAL AND METHODS: In this retrospective study, medical records of 643 discharged patients from ICU of two selected hospitals were examined. The demographic and clinical data of all patients and data of resources and services usage for patients with PU were extracted through their records. Data analysis was done using logistic regression tests in SPSS 22 software. The cost of PU treatment was calculated for each grade of ulcer. RESULTS: The findings showed that 8.9% of patients developed PU during their stay in ICU. Muscular paralysis (OR = 5.1), length of stay in ICU (OR = 4.0), diabetes (OR = 3.5) age (OR = 2.9), smoking (OR = 2.1) and trauma (OR = 1.4) were the most important risk factors of PU. The average cost of PU treatment varied from USD 12 for grade I PU to USD 66 834 for grade IV PUs. The total treatment costs for all studied patients with PU was estimated at USD 519 991. CONCLUSION: The cost of PU treatment is significant. Since the preventive measures are more cost-effective than therapeutic measures, therefore, effective preventive interventions are recommended.

The national cost of hospital-acquired pressure injuries in the United States.

Our objective was to estimate the US national cost burden of hospital-acquired pressure injury (HAPI) using economic simulation methods. We created a Markov simulation to estimate costs for staged pressure injuries acquired during hospitalisation from the hospital perspective. The model analysed outcomes of hospitalised adults with acute illness in 1-day cycles until all patients were terminated at the point of discharge or death. Simulations that developed a staged pressure injury after 4 days could advance from Stages 1 to 4 and accrue additional costs for Stages 3 and 4. We measured costs in 2016 US dollars representing the total cost of acute care attributable to HAPI incidence at the patient level and for the entire United States based on the previously reported epidemiology of pressure injury. US HAPI costs could exceed $26.8 billion. About 59% of these costs are disproportionately attributable to a small rate of Stages 3 and 4 full-thickness wounds, which occupy clinician time and hospital resources. HAPIs remain a concern with regard to hospital quality in addition to being a major source of economic burden on the US health care system. Hospitals should invest more in quality improvement of early detection and care for pressure injury to avoid higher costs.

Five-layer border dressings as part of a quality improvement bundle to prevent pressure injuries in US skilled nursing facilities and Australian nursing homes: A cost-effectiveness analysis.

The BORDER III trial found that five-layer silicone border dressings effectively prevented pressure injuries in long-term care, but the value of this approach is unknown. Our objective was to analyse the cost-effectiveness of preventing facility-acquired pressure injuries with a quality improvement bundle, including prophylactic five-layer dressings in US and Australian long-term care. Markov models analysed the cost utility for pressure injuries acquired during long-term care from US and Australian perspectives. Models calibrated outcomes for standard care compared with a dressing-inclusive bundle over 18 monthly cycles or until death based on BORDER III outcomes. Patients who developed a pressure injury simulated advancement through stages 1 to 4. Univariate and multivariate probabilistic sensitivity analyses tested modelling uncertainty. Costs in 2017 USD and quality-adjusted life years (QALYs) were used to calculate an incremental cost-effectiveness ratio (ICER). Dressing use yielded greater QALYs at slightly higher costs from perspectives. The US ICER was $36 652/QALY, while the Australian ICER was $15 898/QALY, both of which fell below a willingness-to-pay threshold of $100 000/QALY. Probabilistic sensitivity analysis favoured dressings as cost-effective for most simulations. A quality improvement bundle, including prophylactic five-layer dressings, is a cost-effective approach for pressure injury prevention in all US and Australia long-term care residents.

The direct cost of pressure injuries in an Australian residential aged care setting.

Pressure injuries have a negative effect on well-being and the cost of treatment places a significant burden on the health care system. Research has, however, tended to extrapolate or estimate the cost of pressure injuries resulting in uncertainty regarding the true cost of this condition. The aim of this prospective observational study was to quantify the cost of pressure injury treatment in the Australian residential aged care setting. An electronic health care record audit and observation of usual pressure injury treatment was undertaken with a sample of 20 participants who had 23 pressure injuries. The actual treatment cost, an evidence-based practice model cost, and a projected treatment cost were calculated. The overall cost of pressure injury treatment was AU$98,489.22. The average daily cost by pressure injury stage was AU$26.42 for a Stage 1 pressure injury, AU$37.17 for a Stage 2 pressure injury, AU$30.01 for a Stage 3 pressure injury, and AU$10.22 for an Unstageable pressure injury. The projected cost of treatment was AU$104,510.41. At 42 days this cost extended to AU$116,552.79. This study has quantified the cost of pressure injury treatment in a residential aged care setting. The study may inform future efforts to accurately calculate the cost of PIs and the effectiveness of strategies to reduce the economic burden of this condition.

Incisional negative pressure therapy reduces complications and costs in pressure ulcer reconstruction.

Complications after pressure ulcer reconstruction are common. A complication rate of 21% to 58% and a 27% wound recurrence has been reported. The aim of this study was to decrease postoperative wound-healing complications with incisional negative pressure wound therapy (iNPWT) postoperatively. This was a prospective non-randomised trial with a historic control. Surgically treated pressure ulcer patients receiving iNPWT were included in the prospective part of the study (Treatment group) and compared with the historic patient cohort of all consecutive surgically treated pressure ulcer patients during a 2-year period preceding the initiation of iNPWT (Control). There were 24 patients in the Control and 37 in the Treatment groups. The demographics between groups were similar. There was a 74% reduction in in-hospital complications in the Treatment group (10.8% vs 41.7%, P = 0.0051), 27% reduction in the length of stay (24.8 vs 33.8 days, P = 0.0103), and a 78% reduction in the number of open wounds at 3 months (5.4 vs 25%, P = -0.0481). Recurrent wounds and history of previous surgery were risk factors for complications. Incisional negative pressure wound therapy shortens hospital stay, number of postoperative complications, and the number of recurrent open wounds at 3 months after reconstructive pressure ulcer surgery, resulting in significant cost savings.

Developing the tissue viability seating guidelines.

BACKGROUND: Costs for the prevention and management of pressure ulcers have increased significantly with limited published advice from health and social care organisations on seating and preventing pressure ulcers. At the request of the UK Tissue Viability Society the aim of the publication was to develop a practical guide for people, carers and health and social care professionals on how the research and evidence base on pressure ulcer prevention and management can be applied to those who remain seated for extended periods of time. METHODS AND FINDINGS: The evidence base informing the guidelines was obtained by applying a triangulation of methods: a literature review, listening event and stakeholder group consultation. The purpose was to engage users and carers, academics, clinicians, inspectorate and charities, with an interest in seating, positioning and pressure management to: gather views, feedback, stories, and evidence of the current practices in the field to create a greater awareness of the issue. CONCLUSION: The new guidelines are inclusive of all people with short and long-term mobility issues to include all population groups. The document includes evidence on where pressure ulcers develop when seated, risk factors, best possible seated position and what seat adjustments are required, the ideal seating assessment, interventions, self-help suggestions and key seating outcomes. The updated TVS CPGs have been informed by the best available evidence, the insights and wisdom of experts, stakeholders and people who spend extended periods of time sitting.

[Mobilising the team and the patient to prevent pressure ulcers]. / Se mobiliser, en équipe et avec le patient, pour prévenir les escarres.

The occurrence of a pressure ulcer can be considered as an avoidable adverse event. Its consequences are not only very harmful for the patient, but also in terms of the costs induced and for the nursing teams faced with the failure of the prevention treatment. For these reasons, nurses, nurse assistants and the multidisciplinary team must work together around a pressure ulcer prevention strategy.

A cost minimization analysis of olive oil vs. hyperoxygenated fatty acid treatment for the prevention of pressure ulcers in primary healthcare: A randomized controlled trial.

Pressure ulcers represent a major current health problem and cause an important economic impact on the healthcare system. Most studies on the prevention of pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids (HOFA), and to date no studies have specifically examined the use of olive oil-based treatments. AIM: To evaluate the cost of using extra virgin olive oil, rather than HOFA, in the prevention of pressure ulcers among persons with impaired mobility and receiving home care. STUDY DESIGN: Cost minimization analysis of the results obtained from a noninferiority, triple-blind, parallel, multicenter, randomized clinical trial. Population attending primary healthcare centers in Andalusia (Spain). STUDY SAMPLE: 831 immobilized patients at risk of suffering pressure ulcers. These persons were included in the study and randomly assigned as follows: 437 to the olive oil group and 394 to the HOFA group. At the end of the follow-up period, the results obtained by the olive oil group were not inferior to those of the HOFA group, and did not exceed the 10% delta limit. The total treatment cost for 16 weeks was €19,758 with HOFAs and €9,566 with olive oil. Overall, the olive oil treatment was €10,192 less costly. It has been concluded the noninferiority of olive oil makes this product an effective alternative for the prevention of pressure ulcers in patients who are immobilized and in a domestic environment. This treatment enables considerable savings in direct costs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01595347. Date: 2011-2013.

Cost-effectiveness analysis of telephone-based support for the management of pressure ulcers in people with spinal cord injury in India and Bangladesh.

OBJECTIVE: To determine from a societal perspective the cost-effectiveness and cost-utility of telephone-based support for management of pressure ulcers. STUDY DESIGN: Cost-effectiveness and cost-utility analysis of a randomised clinical trial. SETTING: Tertiary centre in India and Bangladesh. METHODS: An economic evaluation was conducted alongside a randomised clinical trial comparing 12 weeks of telephone-based support (intervention group) with usual care (control group). The analyses evaluated costs and health outcomes in terms of cm2 reduction of pressure ulcers size and quality-adjusted life years (QALYs) gained. All costs were in Indian Rupees (INR) and then converted to US dollars (USD). RESULTS: The mean (95% confidence interval) between-group difference for the reduction in size of pressure ulcers was 0.53 (-3.12 to 4.32) cm2, favouring the intervention group. The corresponding QALYs were 0.027 (0.004-0.051), favouring the intervention group. The mean total cost per participant in the intervention group was INR 43 781 (USD 2460) compared to INR 42 561 (USD 2391) for the control group. The per participant cost of delivering the intervention was INR 2110 (USD 119). The incremental cost-effectiveness ratio was INR 2306 (USD 130) per additional cm2 reduction in the size of the pressure ulcer and INR 44 915 (USD 2523) per QALY gained. CONCLUSION: In terms of QALYs, telephone-based support to help people manage pressure ulcers at home provides good value for money and has an 87% probability of being cost-effective, based on 3 times gross domestic product. Sensitivity analyses were performed using the overall cost data with and without productivity costs, and did not alter this conclusion.

Telephone-based management of pressure ulcers in people with spinal cord injury in low- and middle-income countries: a randomised controlled trial.

STUDY DESIGN: A multicentre, prospective, assessor-blinded, parallel randomised controlled trial. OBJECTIVES: The objective of the trial was to determine the effectiveness of telephone-based management of pressure ulcers in people with spinal cord injury (SCI) in low- and middle-income countries. METHODS: One hundred and twenty people with SCI living in the community were recruited through three hospitals in India and Bangladesh between November 2013 and March 2016. Participants had sustained an SCI >3 months prior and had a pressure ulcer. Participants were randomly allocated (1:1) to a control or intervention group. Participants in the control group received no intervention. Participants in the intervention group received weekly advice by telephone for 12 weeks about the management of their pressure ulcers from a trained health-care professional. Outcomes were measured by a blinded assessor at baseline and 12 weeks. There was one primary outcome, namely, the size of the pressure ulcer and 13 secondary outcomes. RESULTS: The mean between-group difference for the size of the pressure ulcer at 12 weeks was 2.3 cm2 (95% confidence interval -0.3 to 4.9; favouring the intervention group). Eight of the 13 secondary outcomes were statistically significant. CONCLUSION: The results of our primary outcome (that is, size of pressure ulcer) do not provide conclusive evidence that people with SCI can be supported at home to manage their pressure ulcers through regular telephone-based advice. However, the results from the secondary outcomes are sufficiently positive to provide hope that this simple intervention may provide some relief from this insidious problem in the future.

PROTECT - trial: a multicentre prospective pragmatic RCT and health economic analysis of the effect of tailored repositioning to prevent pressure ulcers - study protocol.

AIM: The aims of this trial were as follows: (1) to compare the (cost-) effectiveness of a turning and repositioning system and an algorithm for a tailored repositioning vs. usual care to improve reposition frequency in patients at risk; and (2) to compare the (cost-) effectiveness of standardized incontinence care vs. usual care. BACKGROUND: Pressure ulcers are a serious and common problem for hospitalized patients. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for health care. International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. Interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. There is a lack of rigorous research addressing the effectiveness of a turning and repositioning system and it is unclear how to tailor the frequency and posture to specific patient needs. DESIGN: Multicentre, cluster, three-arm, randomized, controlled pragmatic trial and a cost-effectiveness analysis. The ward is the unit of randomization. METHODS: Tailored repositioning, the use of a device to facilitate patient repositioning and an optimal procedure for incontinence care will be combined. Participating wards will be intensive care units, geriatric and rehabilitation wards. A sample size calculation was performed (80% power, α = 0·05). This study is approved by the Ethics Committee (February 2016). DISCUSSION: Data collection is currently ongoing. The results are expected to be obtained in March 2017.