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TEAM-UP for quality: a cluster randomized controlled trial protocol focused on preventing pressure ulcers through repositioning frequency and precipitating factors.

ABSTRACT: Pressure ulcers/injuries (PrUs), a critical concern for nursing homes (NH), are responsible for chronic wounds, amputations, septic infections, and premature deaths. PrUs occur most commonly in older adults and NH residence is a risk factor for their development, with at least one of every nine U.S. NH residents experiencing a PrU and many NHs having high incidence and prevalence rates, in some instances well over 20%. PrU direct treatment costs are greater than prevention costs, making prevention-focused protocols critical. Current PrU prevention protocols recommend repositioning residents at moderate, high, and severe risk every 2 h. The advent of visco-elastic (VE) high-density foam support-surfaces over the past decade may now make it possible to extend the repositioning interval to every 3 or 4 h without increasing PrU development. The TEAM-UP (Turn Everyone And Move for Ulcer Prevention) study aims to determine: 1) whether repositioning interval can be extended for NH residents without compromising PrU incidence and 2) how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development.In this proposed cluster randomized study, 9 NHs will be randomly assigned to one of three repositioning intervals (2, 3, or 4 h) for a 4-week period. Each enrolled site will use a single NH-wide repositioning interval as the standard of care for residents at low, moderate, and high risk of PrU development (N?=?951) meeting the following criteria: minimum 3-day stay, without PrUs, no adhesive allergy, and using VE support surfaces (mattresses). An FDA-cleared patient monitoring system that records position/movement of these residents via individual wireless sensors will be used to visually cue staff when residents need repositioning and document compliance with repositioning protocols.This study will advance knowledge about repositioning frequency and clinically assessed PrU risk level in relation to PrU incidence and medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.Clinical Trial Registration: NCT02996331 .

SUBMITTER: Yap TL

PROVIDER: S-EPMC5820803 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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TEAM-UP for quality: a cluster randomized controlled trial protocol focused on preventing pressure ulcers through repositioning frequency and precipitating factors.

Yap Tracey L TL Kennerly Susan M SM Horn Susan D SD Bergstrom Nancy N Datta Santanu S Colon-Emeric Cathleen C

BMC geriatrics 20180220 1

<h4>Background</h4>Pressure ulcers/injuries (PrUs), a critical concern for nursing homes (NH), are responsible for chronic wounds, amputations, septic infections, and premature deaths. PrUs occur most commonly in older adults and NH residence is a risk factor for their development, with at least one of every nine U.S. NH residents experiencing a PrU and many NHs having high incidence and prevalence rates, in some instances well over 20%. PrU direct treatment costs are greater than prevention cos ...[more]

PMID: 29463211

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Project description:BackgroundDespite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients' tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals.MethodsA nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients' level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study.ConclusionThis study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk.Trial registrationPENFUP phase-2 was Registered in Clinicaltrials.gov ( NCT04604665 ) in October 2020.

Project description:BackgroundPressure ulcers affect approximately 10% of people in hospitals and older people are at highest risk. A correlation between inadequate nutritional intake and the development of pressure ulcers has been suggested by several studies, but the results have been inconsistent.ObjectivesTo evaluate the effects of enteral and parenteral nutrition on the prevention and treatment of pressure ulcers.Search methodsIn March 2014, for this first update, we searched The Cochrane Wounds Group Specialised Trials Register, the Cochrane Central register of Controlled Trials (The Cochrane Library), the Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library), the Health Technology Assessment Database (HTA) (The Cochrane Library), the Cochrane Methodology Register (The Cochrane Library), NHS Economic Evaluation Database (The Cochrane Library), Ovid Medline, Ovid Embase and EBSCO CINAHL. No date, language or publication status limits were applied.Selection criteriaRandomised controlled trials (RCTs) evaluating the effects of enteral or parenteral nutrition on the prevention and treatment of pressure ulcers, which measured the incidence of new ulcers, ulcer healing or changes in pressure ulcer severity. There were no restrictions on types of patient, setting, date, publication status or language.Data collection and analysisTwo review authors independently screened for inclusion, and disagreement was resolved by discussion. Two review authors independently extracted data and assessed quality using the Cochrane Collaboration tool for assessing risk of bias.Main resultsWe included 23 RCTs, many were small (between 9 and 4023 participants, median 88) and at high risk of bias.Eleven trials compared a combination of nutritional supplements, consisting of a minimum of energy and protein in different dosages, for the prevention of pressure ulcers. A meta-analysis of eight trials (6062 participants) that compared the effects of mixed nutritional supplements with standard hospital diet found no clear evidence of an effect of supplementation on pressure ulcer development (pooled RR 0.86; 95% CI 0.73 to 1.00; P value 0.05; I(2) = 13%, random effects). This outcome is at unclear or high risk of bias.Fourteen trials evaluated the effects of nutritional supplements on the healing of existing pressure ulcers: seven trials examined mixed nutritional supplements, three the effects of proteins, two trials examined zinc, and two studies examined ascorbic acid. The included trials were heterogeneous with regard to participants, interventions, comparisons and outcomes and meta-analysis was not appropriate. There was no clear evidence of an improvement in pressure ulcer healing from the nutritional supplements evaluated in any of these individual studies.Authors' conclusionsThere is currently no clear evidence of a benefit associated with nutritional interventions for either the prevention or treatment of pressure ulcers. Further trials of high methodological quality are necessary.

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TEAM-UP for quality: a cluster randomized controlled trial protocol focused on preventing pressure ulcers through repositioning frequency and precipitating factors.

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TEAM-UP for quality: a cluster randomized controlled trial protocol focused on preventing pressure ulcers through repositioning frequency and precipitating factors.

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