Pressure Ulcer Prevention: Turning for Ulcer Reduction

NCT00665535 | Completed Phase 3 DMC

• 1 other identifier: 1R011NR009680-01A1
• Study Type: interventional
• Target: 967
• Locations: 2 countries
• Sites: 26

Brief 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.

Conditions

Pressure Ulcers

Keywords

Pressure ulcers; Nursing facilities; Elderly; At risk for pressure ulcers

Outcome Measures

Primary Outcomes (1)

• Pressure ulcers, present (stage)or absent

  End of 3rd week or conclusion of participation

Study Arms (2)

2. High Risk

OTHER

High risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12)

Procedure: Turning or repositioning schedule

1. Moderate Risk

OTHER

Moderate risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 13 and 14)

Procedure: Turning or repositioning schedule

Interventions

Turning or repositioning schedule PROCEDURE

Turning schedule randomly assigned at 2, 3, or 4 hours

1. Moderate Risk

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator
• National Institute on Aging (NIA): collaborator
• Ontario Ministry of Health and Long Term Care: collaborator
• Toronto Health Economic Technology Assessment collaborative (THETA): collaborator

Study Sites (26)

Glencroft Care Center

Glendale, Arizona, 85302, United States

Location

Linda Valley Nursing Facility

Loma Linda, California, 92354, United States

Location

Garden Crest Convalescent Hospital

Los Angeles, California, 90026, United States

Location

St. Catherine Laboure Manor

Jacksonville, Florida, 32204, United States

Location

Miami Jewish Home & Hospital

Miami, Florida, 33137, United States

Location

Palatka Health Care Center

Palatka, Florida, 32177, United States

Location

Kindred Bremen Health Care Center

Bremen, Indiana, 46506, United States

Location

Tower Hill Center for Health and Rehabilitation

Canton, Massachusetts, 02021, United States

Location

Gurwin Jewish Nursing and Rehabilitation Center

Commack, New York, 11725-4403, United States

Location

Monroe Community Hospital

Rochester, New York, 14620, United States

Location

BlumenthalJewish Nursing and Rehabilitation

Greensboro, North Carolina, 27455, United States

Location

Hennis Care Center

Dover, Ohio, 44622, United States

Location

Dorothy Love Retirement Community

Sidney, Ohio, 45365, United States

Location

Fairmount at aBreckenridge Village

Willoughby, Ohio, 44504, United States

Location

Park Vista Retirement Community

Youngstown, Ohio, 44094, United States

Location

Signature HealthCare of Columbia

Columbia, Tennessee, 38401, United States

Location

Kindred Loudon Healthcare Center

Loudon, Tennessee, 37774, United States

Location

Kindred Fairpark Health Care Center

Maryville, Tennessee, 37802, United States

Location

Asbury Place Maryville

Maryville, Tennessee, 37804, United States

Location

Tyndall Nursing Home

East Missassauga, Ontario, L4W 1K3, Canada

Location

Malton Village Long Term Care Center

Mississauga, Ontario, L4T4M1, Canada

Location

Specialty Care of Mississauga Road

Mississauga, Ontario, L5M 7C3, Canada

Location

Yee Hong Scarborough

Scarborough Village, Ontario, M1S 5T7, Canada

Location

Shepherd Lodge

Scarborough Village, Ontario, M1T 3K9, Canada

Location

Leisure World Lawrence

Toronto, Ontario, M9N 3V4, Canada

Location

Villa Leonardo Gambin Specialty Care

Woodbridge, Ontario, L4L 9T3, Canada

Location

Related Publications (2)

• Yap TL, Kennerly SM, Bergstrom N, Hudak SL, Horn SD. An Evidence-Based Cue-Selection Guide and Logic Model to Improve Pressure Ulcer Prevention in Long-term Care. J Nurs Care Qual. 2016 Jan-Mar;31(1):75-83. doi: 10.1097/NCQ.0000000000000128.

  PMID: 26066791 DERIVED

• Omolayo T, Brown K, Rapp MP, Li J, Barrett R, Horn S, Bergstrom N. Construct validity of the moisture subscale of the Braden Scale for Predicting Pressure Sore Risk. Adv Skin Wound Care. 2013 Mar;26(3):122-7. doi: 10.1097/01.ASW.0000427921.74379.c5.

  PMID: 23426413 DERIVED

Related Links

• Home of the Braden Scale and source of official copies of the tool and the location for obtaining permission to use the tool.
• Home of the National Pressure Ulcer Advisory Panel with information regarding staging and policies regarding pressure ulcers
• Home page of the Wound Ostomy and Continence Nurses Organization, the experts in wound healing.
• Hennis Care Center of Dover, Ohio is a data collection site
• Gurwin Jewish Nursing and Rehabilitation Center, Commack, NY, is a data collection site
• Monro Community Hospital, Rochester, NY, is a data collection sites
• Specialty Care Mississauga Road, Mississauga, Ontario, Canada is a data collection site
• Villa Leonardo Gambin, Woodbridge, Ontario, Canada is a data collection site
• Fairmount at Breckenridge Village is a data collection site
• St. Catherine Laboure Manor is a data collection site
• Kindred Bremen Health Care Center
• Miami Jewish Home \& Hospital will be a data collection site
• Kindred Fairpark Health Care Center is a data collection site
• Kindred Loudon Healthcare Center is a data collection site
• Related Info
• Related Info
• Related Info

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nancy Bergstrom, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Susan Horn, PhD

  ISIS, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trumble Professor of Aging Research & Director, Center on Aging

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

US (19); CA (7)