Pressure Ulcer Prevention: Turning for Ulcer Reduction

Pressure Ulcers Clinical Trial

— TURN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665535
• Other study ID #: 1R011NR009680-01A1
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2008
• Last updated: March 20, 2012
• Start date: March 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2012
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 967
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Procedure:
• Turning or repositioning schedule
Turning schedule randomly assigned at 2, 3, or 4 hours
• Turning or repositioning schedule
Turning schedule randomly assigned at 2, 3 or 4 hours

Locations

Country	Name	City	State
Canada	Tyndall Nursing Home	East Missassauga	Ontario
Canada	Malton Village Long Term Care Center	Mississauga	Ontario
Canada	Specialty Care of Mississauga Road	Mississauga	Ontario
Canada	Shepherd Lodge	Scarborough	Ontario
Canada	Yee Hong Scarborough	Scarborough	Ontario
Canada	Leisure World Lawrence	Toronto	Ontario
Canada	Villa Leonardo Gambin Specialty Care	Woodbridge	Ontario
United States	Kindred Bremen Health Care Center	Bremen	Indiana
United States	Tower Hill Center for Health and Rehabilitation	Canton	Massachusetts
United States	Signature HealthCare of Columbia	Columbia	Tennessee
United States	Gurwin Jewish Nursing and Rehabilitation Center	Commack	New York
United States	Hennis Care Center	Dover	Ohio
United States	Glencroft Care Center	Glendale	Arizona
United States	BlumenthalJewish Nursing and Rehabilitation	Greensboro	North Carolina
United States	St. Catherine Laboure Manor	Jacksonville	Florida
United States	Linda Valley Nursing Facility	Loma Linda	California
United States	Garden Crest Convalescent Hospital	Los Angeles	California
United States	Kindred Loudon Healthcare Center	Loudon	Tennessee
United States	Asbury Place Maryville	Maryville	Tennessee
United States	Kindred Fairpark Health Care Center	Maryville	Tennessee
United States	Miami Jewish Home & Hospital	Miami	Florida
United States	Palatka Health Care Center	Palatka	Florida
United States	Monroe Community Hospital	Rochester	New York
United States	Dorothy Love Retirement Community	Sidney	Ohio
United States	Fairmount at aBreckenridge Village	Willoughby	Ohio
United States	Park Vista Retirement Community	Youngstown	Ohio

Sponsors (6)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure ulcers, present (stage)or absent		End of 3rd week or conclusion of participation	Yes

External Links

•   Link
•   Link
•   Dorothy Love Retirement Community is a data collection site
•   Fairmount at Breckenridge Village is a data collection site
•   Gurwin Jewish Nursing and Rehabilitation Center, Commack, NY, is a data collection site
•   Hennis Care Center of Dover, Ohio is a data collection site
•   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.
•   Malton Village Long Term Care Center, Ontario, Canada is a data collection site
•   Miami Jewish Home & Hospital will be 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