Pressure Ulcer Prevention: Turning for Ulcer Reduction (TURN)

March 20, 2012 updated by: Nancy Bergstrom, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

967

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • East Missassauga, Ontario, Canada, L4W 1K3
        • Tyndall Nursing Home
      • Mississauga, Ontario, Canada, L4T4M1
        • Malton Village Long Term Care Center
      • Mississauga, Ontario, Canada, L5M 7C3
        • Specialty Care of Mississauga Road
      • Scarborough, Ontario, Canada, M1S 5T7
        • Yee Hong Scarborough
      • Scarborough, Ontario, Canada, M1T 3K9
        • Shepherd Lodge
      • Toronto, Ontario, Canada, M9N 3V4
        • Leisure World Lawrence
      • Woodbridge, Ontario, Canada, L4L 9T3
        • Villa Leonardo Gambin Specialty Care
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85302
        • Glencroft Care Center
    • California
      • Loma Linda, California, United States, 92354
        • Linda Valley Nursing Facility
      • Los Angeles, California, United States, 90026
        • Garden Crest Convalescent Hospital
    • Florida
      • Jacksonville, Florida, United States, 32204
        • St. Catherine Laboure Manor
      • Miami, Florida, United States, 33137
        • Miami Jewish Home & Hospital
      • Palatka, Florida, United States, 32177
        • Palatka Health Care Center
    • Indiana
      • Bremen, Indiana, United States, 46506
        • Kindred Bremen Health Care Center
    • Massachusetts
      • Canton, Massachusetts, United States, 02021
        • Tower Hill Center for Health and Rehabilitation
    • New York
      • Commack, New York, United States, 11725-4403
        • Gurwin Jewish Nursing and Rehabilitation Center
      • Rochester, New York, United States, 14620
        • Monroe Community Hospital
    • North Carolina
      • Greensboro, North Carolina, United States, 27455
        • BlumenthalJewish Nursing and Rehabilitation
    • Ohio
      • Dover, Ohio, United States, 44622
        • Hennis Care Center
      • Sidney, Ohio, United States, 45365
        • Dorothy Love Retirement Community
      • Willoughby, Ohio, United States, 44504
        • Fairmount at aBreckenridge Village
      • Youngstown, Ohio, United States, 44094
        • Park Vista Retirement Community
    • Tennessee
      • Columbia, Tennessee, United States, 38401
        • Signature HealthCare of Columbia
      • Loudon, Tennessee, United States, 37774
        • Kindred Loudon Healthcare Center
      • Maryville, Tennessee, United States, 37802
        • Kindred Fairpark Health Care Center
      • Maryville, Tennessee, United States, 37804
        • Asbury Place Maryville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Ontario Ministry of Health and Long Term Care
Toronto Health Economic Technology Assessment collaborative (THETA)

Investigators

  • Principal Investigator: Nancy Bergstrom, PhD, The University of Texas Health Science Center, Houston
  • Principal Investigator: Susan Horn, PhD, ISIS, Salt Lake City, UT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R011NR009680-01A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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