Pressure Ulcer Prevention: Turning for Ulcer Reduction

Study Overview
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Brief Summary
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The purpose of the study is to determine the optimal frequency of repositioning nursing facility residents with limited mobility who are cared for on a high density foam mattress in order to prevent bed sores. It is hypothesized that participants at moderate risk (Braden Scale Scores 13-14) who are turned every 3 or 4 hours and participants at high risk (Braden Scores 10-12) turned every 3 or 4 hours will not have a higher incidence of ulcers than those residents turned every 2 hours.

Detailed Description
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The purpose of this multi-site, randomized, controlled trial is to determine the optimal frequency of repositioning nursing facility residents with mobility limitations who are at moderate and high risk for pressure ulcer development who are cared for on high density foam mattresses for the purpose of preventing pressure ulcers. Pressure ulcers result primarily from pressure over a bony prominence that occludes blood flow to tissues. Traditionally, soft surfaces over mattress and repositioning individuals every 2 hours to relieve pressure have been the gold standard of care to prevent ulcers. Recent improvements in support surfaces may reduce the need for 2-hour repositioning. The specific aims of this study are to determine if: 1) there is a significant difference in the incidence of pressure ulcers among: a) moderate risk (Braden Scale Score, 13-14) residents randomly assigned to be repositioned every 2-, compared with every 3- or 4- hours; or b) high risk (Braden Scale Score, 10-12) residents who are turned every 2- compared with every 3- or 4-hours; 2) mobility (spontaneous or assisted) measured by actigraphy is a significant covariate with repositioning frequency in the incidence of pressure ulcers and 3) resident characteristics and resident influencing factors are significant covariates of repositioning schedules on pressure ulcer incidence. A 2 X 2/2 X 3 experimental design is used in which participants at two levels of risk (moderate or high) for pressure ulcer development are randomly assigned to one of 3 repositioning schedules every 2-hours (the current standard of care), contrasted with 3- or 4- hours carried out for 3 weeks. Actigraphs worn for 7 days (Tuesday to Tuesday) will determine if mobility is a significant covariate. Residents (1080) who are over 65 years, able to give consent or have a surrogate who can give consent and are at moderate or high risk for pressure ulcers will be invited to participate. Nursing facilities are selected because of their ability to follow a research protocol and submit data according to protocol requirements, and who have a reputation for good care are being selected for participation. Participants will be randomly assigned to a repositioning schedule that will be carried out by a Certified Nursing Assistants (CNA) who will document time of each repositioning. A CNA supervisor monitors repositioning and documentation frequently. Data are FAXED to and monitored by the investigators daily. With the exception of the repositioning intervention, participants will receive the same preventive care as all residents. The primary outcome of this study, pressure ulcers (yes/no) will be documented by a nurse assessor who will be masked to the repositioning timing. Data analysis and management will be performed by ISIS. The goal of this study is to shape Nursing Facility policy by defining how level of risk, mobility, and frequency of repositioning of residents can reduce the incidence of pressure ulcers and improve resident outcomes. Less frequent repositioning would allow residents longer periods of sleep, would reduce staff time for repositioning, and allow more efficient allocation of time.

Official Title
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Preventing Pressure Ulcers: A Multi-site RCT in Nursing Facilities

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Procedure: Turning or repositioning schedule
* Procedure: Turning or repositioning schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will: Be free of pressure ulcers upon admission to the study. Have a Braden Scale Score between 10 - 12 (high risk) or 13 -14 (moderate risk) within one week of admission (new residents) or greater than 90 days (established residents) of study participation Have a high-density foam replacement mattress in use or can be transferred to such a mattress. Are 65 years or older. Younger residents are present in fewer numbers and may have different health issues and co-morbidities than older residents. Can legally grant consent to participate or have available surrogates to grant consent. If able, participant should assent when a surrogate grants consent. Expected to have a length of stay of 21 days or greater. Exclusion Criteria: Pressure ulcer is present upon initial examination. The Braden Scale score is 15 or greater indicating mild risk or no risk, or 9 or below indicating very high risk. The resident cannot be turned on 3 anatomical surfaces (side, back, side) or has a contraindication to repositioning.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2. High Risk<br>High risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12) | Procedure: Turning or repositioning schedule<br>* Turning schedule randomly assigned at 2, 3 or 4 hours<br>|
| Other: 1. Moderate Risk<br>Moderate risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 13 and 14) | Procedure: Turning or repositioning schedule<br>* Turning schedule randomly assigned at 2, 3, or 4 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure ulcers, present (stage)or absent |  | End of 3rd week or conclusion of participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcers, Nursing facilities, Elderly, At risk for pressure ulcers