Pressure Ulcer Prevention: Turning for Ulcer Reduction

Last updated: March 20, 2012
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Completed

Phase

3

Condition

Pressure Ulcers

Ulcers

Pressure Ulcer

Treatment

N/A

Clinical Study ID

NCT00665535
1R011NR009680-01A1
  • Ages > 65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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) withinone 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 amattress.

  • Are 65 years or older. Younger residents are present in fewer numbers and may havedifferent health issues and co-morbidities than older residents.

  • Can legally grant consent to participate or have available surrogates to grantconsent. If able, participant should assent when a surrogate grants consent.

  • Expected to have a length of stay of 21 days or greater.

Exclusion

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 belowindicating very high risk.

  • The resident cannot be turned on 3 anatomical surfaces (side, back, side) or has acontraindication to repositioning.

Study Design

Total Participants: 967
Study Start date:
March 01, 2008
Estimated Completion Date:
June 30, 2011

Study Description

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.

Connect with a study center

  • Tyndall Nursing Home

    East Missassauga, Ontario L4W 1K3
    Canada

    Site Not Available

  • Malton Village Long Term Care Center

    Mississauga, Ontario L4T4M1
    Canada

    Site Not Available

  • Specialty Care of Mississauga Road

    Mississauga, Ontario L5M 7C3
    Canada

    Site Not Available

  • Shepherd Lodge

    Scarborough, Ontario M1T 3K9
    Canada

    Site Not Available

  • Yee Hong Scarborough

    Scarborough, Ontario M1S 5T7
    Canada

    Site Not Available

  • Leisure World Lawrence

    Toronto, Ontario M9N 3V4
    Canada

    Site Not Available

  • Villa Leonardo Gambin Specialty Care

    Woodbridge, Ontario L4L 9T3
    Canada

    Site Not Available

  • Glencroft Care Center

    Glendale, Arizona 85302
    United States

    Site Not Available

  • Linda Valley Nursing Facility

    Loma Linda, California 92354
    United States

    Site Not Available

  • Garden Crest Convalescent Hospital

    Los Angeles, California 90026
    United States

    Site Not Available

  • St. Catherine Laboure Manor

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Miami Jewish Home & Hospital

    Miami, Florida 33137
    United States

    Site Not Available

  • Palatka Health Care Center

    Palatka, Florida 32177
    United States

    Site Not Available

  • Kindred Bremen Health Care Center

    Bremen, Indiana 46506
    United States

    Site Not Available

  • Tower Hill Center for Health and Rehabilitation

    Canton, Massachusetts 02021
    United States

    Site Not Available

  • Gurwin Jewish Nursing and Rehabilitation Center

    Commack, New York 11725-4403
    United States

    Site Not Available

  • Monroe Community Hospital

    Rochester, New York 14620
    United States

    Site Not Available

  • BlumenthalJewish Nursing and Rehabilitation

    Greensboro, North Carolina 27455
    United States

    Site Not Available

  • Hennis Care Center

    Dover, Ohio 44622
    United States

    Site Not Available

  • Dorothy Love Retirement Community

    Sidney, Ohio 45365
    United States

    Site Not Available

  • Fairmount at aBreckenridge Village

    Willoughby, Ohio 44504
    United States

    Site Not Available

  • Park Vista Retirement Community

    Youngstown, Ohio 44094
    United States

    Site Not Available

  • Signature HealthCare of Columbia

    Columbia, Tennessee 38401
    United States

    Site Not Available

  • Kindred Loudon Healthcare Center

    Loudon, Tennessee 37774
    United States

    Site Not Available

  • Asbury Place Maryville

    Maryville, Tennessee 37804
    United States

    Site Not Available

  • Kindred Fairpark Health Care Center

    Maryville, Tennessee 37802
    United States

    Site Not Available

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