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

April 22, 2008
March 20, 2012
March 2008
June 2011   (final data collection date for primary outcome measure)
Pressure ulcers, present (stage)or absent [ Time Frame: End of 3rd week or conclusion of participation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00665535 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pressure Ulcer Prevention: Turning for Ulcer Reduction
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Pressure Ulcers
  • 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
  • 2. High Risk
    High risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12)
    Intervention: Procedure: Turning or repositioning schedule
  • 1. Moderate Risk
    Moderate risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 13 and 14)
    Intervention: Procedure: Turning or repositioning schedule
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
967
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00665535
1R011NR009680-01A1
Yes
Nancy Bergstrom, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
  • National Institutes of Health (NIH)
  • National Institute of Nursing Research (NINR)
  • National Institute on Aging (NIA)
  • Ontario Ministry of Health and Long Term Care
  • Toronto Health Economic Technology Assessment collaborative (THETA)
Principal Investigator: Nancy Bergstrom, PhD The University of Texas Health Science Center, Houston
Principal Investigator: Susan Horn, PhD ISIS, Salt Lake City, UT
The University of Texas Health Science Center, Houston
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP