Pressure Ulcer Prevention: Turning for Ulcer Reduction (TURN)

This study has been completed.
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
Toronto Health Economic Technology Assessment collaborative (THETA)
Information provided by (Responsible Party):
Nancy Bergstrom, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00665535
First received: April 22, 2008
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Pressure Ulcers
Procedure: Turning or repositioning schedule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Pressure Ulcers: A Multi-site RCT in Nursing Facilities

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Pressure ulcers, present (stage)or absent [ Time Frame: End of 3rd week or conclusion of participation ] [ Designated as safety issue: Yes ]

Enrollment: 967
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665535

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

Additional Information:
No publications provided by The University of Texas Health Science Center, Houston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Bergstrom, Trumble Professor of Aging Research & Director, Center on Aging, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00665535     History of Changes
Other Study ID Numbers: 1R011NR009680-01A1
Study First Received: April 22, 2008
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Pressure ulcers
Nursing facilities
Elderly
At risk for pressure ulcers

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014