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Turning for Ulcer Reduction (TURN)
This study is currently recruiting participants.
Verified by The University of Texas Health Science Center, Houston, October 2008
Sponsored by: The University of Texas Health Science Center, Houston
Information provided by: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00665535
  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 2, 3 or 4 hours and participants at high risk (Braden Scores 10-12) turned every 2 or 3 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 III

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Preventing Pressure Ulcers: A Multi-Site RCT in Nursing Facilities

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 ]

Estimated Enrollment: 900
Study Start Date: March 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 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 or 3 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-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 (900) 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:

  1. Be free of pressure ulcers upon admission to the study.
  2. 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
  3. Have a high-density foam replacement mattress in use or can be transferred to such a mattress.
  4. Are 65 years or older. Younger residents are present in fewer numbers and may have different health issues and co-morbidities than older residents.
  5. Can legally grant consent to participate or have available surrogates to grant consent. If able, participant should assent when a surrogate grants consent.
  6. Expected to have a length of stay of 21 days or greater.

Exclusion Criteria:

  1. Pressure ulcer is present upon initial examination.
  2. The Braden Scale score is 15 or greater indicating mild risk or no risk, or 9 or below indicating very high risk.
  3. The resident cannot be turned on 3 anatomical surfaces (side, back, side) or has a contraindication to repositioning.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665535

Contacts
Contact: Mary Pat Rapp, PhD 281-794-7345 Mary.P.Rapp@uth.tmc.edu
Contact: Nancy Bergstrom, PhD 713-500-9920 Nancy.Bergstrom@uth.tmc.edu

Locations
United States, Florida
Palatka Health Care Center Recruiting
Palatka, Florida, United States, 32177
Contact: Patricia Freeman     386-325-0173     freemphcc@bellsouth.net    
Contact: Marcia Lyles     386-325-0173        
Principal Investigator: Marcia Lyles            
United States, New York
Gurwin Jewish Nursing and Rehabilitation Center Recruiting
Commack, New York, United States, 11725-4403
Contact: Joanne Parisi     631-715-2577     jparisi@gurwin.org    
Contact: Jean Marie Kineiko     386-715-2410     jkineiko@gurwin.org    
Principal Investigator: Joanne Parisi            
Monroe Community Hospital Recruiting
Rochester, New York, United States, 14620
Contact: Ruth Dorrough     585-760-6323     rdorrough@monroehosp.org    
Contact: Jane Banzhaf     585-760-6500     JBanzhaf@monroehosp.org    
Principal Investigator: Ruth Dorrough            
United States, Ohio
Hennis Care Center Recruiting
Dover, Ohio, United States, 44622
Contact: Anita Peffer, BS     330-364-8849     apeffer@henniscarecentre.com    
Contact: Rhonda Arter     330-364-8849     rarter@henniscarecenter.com    
Principal Investigator: Anita Peffer, BSN            
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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

Study web site  This link exits the ClinicalTrials.gov site
Home of the Braden Scale and source of official copies of the tool and the location for obtaining permission to use the tool.  This link exits the ClinicalTrials.gov site
Home of the National Pressure Ulcer Advisory Panel with information regarding staging and policies regarding pressure ulcers  This link exits the ClinicalTrials.gov site
Home page of the Wound Ostomy and Continence Nurses Organization, the experts in wound healing.  This link exits the ClinicalTrials.gov site
Hennis Care Center of Dover, Ohio is one of our data collection sites.  This link exits the ClinicalTrials.gov site

Responsible Party: University of Texas-Houston ( Nancy I. Bergstrom, Trumble Professor of Aging Research )
Study ID Numbers: 1R011NR009680-01A1
Study First Received: April 22, 2008
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00665535  
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

Study placed in the following topic categories:
Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009