Pressure Ulcer Prevention: Turning for Ulcer Reduction (TURN)
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Turning or repositioning schedule
Turning or repositioning schedule
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcers focused on measuring Pressure ulcers, Nursing facilities, Elderly, At risk for pressure ulcers
Eligibility 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.
Sites / Locations
- Glencroft Care Center
- Linda Valley Nursing Facility
- Garden Crest Convalescent Hospital
- St. Catherine Laboure Manor
- Miami Jewish Home & Hospital
- Palatka Health Care Center
- Kindred Bremen Health Care Center
- Tower Hill Center for Health and Rehabilitation
- Gurwin Jewish Nursing and Rehabilitation Center
- Monroe Community Hospital
- BlumenthalJewish Nursing and Rehabilitation
- Hennis Care Center
- Dorothy Love Retirement Community
- Fairmount at aBreckenridge Village
- Park Vista Retirement Community
- Signature HealthCare of Columbia
- Kindred Loudon Healthcare Center
- Kindred Fairpark Health Care Center
- Asbury Place Maryville
- Tyndall Nursing Home
- Malton Village Long Term Care Center
- Specialty Care of Mississauga Road
- Yee Hong Scarborough
- Shepherd Lodge
- Leisure World Lawrence
- Villa Leonardo Gambin Specialty Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
2. High Risk
1. Moderate Risk
Arm Description
High risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12)
Moderate risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 13 and 14)
Outcomes
Primary Outcome Measures
Pressure ulcers, present (stage)or absent
Secondary Outcome Measures
Full Information
NCT ID
NCT00665535
First Posted
April 22, 2008
Last Updated
March 20, 2012
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
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)
1. Study Identification
Unique Protocol Identification Number
NCT00665535
Brief Title
Pressure Ulcer Prevention: Turning for Ulcer Reduction
Acronym
TURN
Official Title
Preventing Pressure Ulcers: A Multi-site RCT in Nursing Facilities
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
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)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
Pressure ulcers, Nursing facilities, Elderly, At risk for pressure ulcers
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
967 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2. High Risk
Arm Type
Other
Arm Description
High risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12)
Arm Title
1. Moderate Risk
Arm Type
Other
Arm Description
Moderate risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 13 and 14)
Intervention Type
Procedure
Intervention Name(s)
Turning or repositioning schedule
Intervention Description
Turning schedule randomly assigned at 2, 3, or 4 hours
Intervention Type
Procedure
Intervention Name(s)
Turning or repositioning schedule
Intervention Description
Turning schedule randomly assigned at 2, 3 or 4 hours
Primary Outcome Measure Information:
Title
Pressure ulcers, present (stage)or absent
Time Frame
End of 3rd week or conclusion of participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Bergstrom, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Horn, PhD
Organizational Affiliation
ISIS, Salt Lake City, UT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glencroft Care Center
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85302
Country
United States
Facility Name
Linda Valley Nursing Facility
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Garden Crest Convalescent Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90026
Country
United States
Facility Name
St. Catherine Laboure Manor
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Miami Jewish Home & Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Palatka Health Care Center
City
Palatka
State/Province
Florida
ZIP/Postal Code
32177
Country
United States
Facility Name
Kindred Bremen Health Care Center
City
Bremen
State/Province
Indiana
ZIP/Postal Code
46506
Country
United States
Facility Name
Tower Hill Center for Health and Rehabilitation
City
Canton
State/Province
Massachusetts
ZIP/Postal Code
02021
Country
United States
Facility Name
Gurwin Jewish Nursing and Rehabilitation Center
City
Commack
State/Province
New York
ZIP/Postal Code
11725-4403
Country
United States
Facility Name
Monroe Community Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
BlumenthalJewish Nursing and Rehabilitation
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27455
Country
United States
Facility Name
Hennis Care Center
City
Dover
State/Province
Ohio
ZIP/Postal Code
44622
Country
United States
Facility Name
Dorothy Love Retirement Community
City
Sidney
State/Province
Ohio
ZIP/Postal Code
45365
Country
United States
Facility Name
Fairmount at aBreckenridge Village
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44504
Country
United States
Facility Name
Park Vista Retirement Community
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Signature HealthCare of Columbia
City
Columbia
State/Province
Tennessee
ZIP/Postal Code
38401
Country
United States
Facility Name
Kindred Loudon Healthcare Center
City
Loudon
State/Province
Tennessee
ZIP/Postal Code
37774
Country
United States
Facility Name
Kindred Fairpark Health Care Center
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37802
Country
United States
Facility Name
Asbury Place Maryville
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37804
Country
United States
Facility Name
Tyndall Nursing Home
City
East Missassauga
State/Province
Ontario
ZIP/Postal Code
L4W 1K3
Country
Canada
Facility Name
Malton Village Long Term Care Center
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4T4M1
Country
Canada
Facility Name
Specialty Care of Mississauga Road
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 7C3
Country
Canada
Facility Name
Yee Hong Scarborough
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1S 5T7
Country
Canada
Facility Name
Shepherd Lodge
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1T 3K9
Country
Canada
Facility Name
Leisure World Lawrence
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9N 3V4
Country
Canada
Facility Name
Villa Leonardo Gambin Specialty Care
City
Woodbridge
State/Province
Ontario
ZIP/Postal Code
L4L 9T3
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26066791
Citation
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.
Results Reference
derived
PubMed Identifier
23426413
Citation
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.
Results Reference
derived
Links:
URL
http://www.bradenscale.com
Description
Home of the Braden Scale and source of official copies of the tool and the location for obtaining permission to use the tool.
URL
http://www.wocn.org/
Description
Home page of the Wound Ostomy and Continence Nurses Organization, the experts in wound healing.
URL
http://www.henniscarecentre.com/volunteers.htm
Description
Hennis Care Center of Dover, Ohio is a data collection site
URL
http://www.gurwin.org/
Description
Gurwin Jewish Nursing and Rehabilitation Center, Commack, NY, is a data collection site
URL
http://www.monroehosp.org/
Description
Monro Community Hospital, Rochester, NY, is a data collection sites
URL
http://www.specialty-care.com/index.php/mississauga-road
Description
Specialty Care Mississauga Road, Mississauga, Ontario, Canada is a data collection site
URL
http://www.specialty-care.com/index.php/villa-leonardo-gambin
Description
Villa Leonardo Gambin, Woodbridge, Ontario, Canada is a data collection site
URL
http://www.peelregion.ca/ltc/malton/
Description
Malton Village Long Term Care Center, Ontario, Canada is a data collection site
URL
http://www.oprs.org/breckenridge_village/
Description
Fairmount at Breckenridge Village is a data collection site
URL
http://www.jaxhealth.com/AboutUs/default.asp?ENOrgID=B8AD2776B8C74351ABCD7349B0C8D30D
Description
St. Catherine Laboure Manor is a data collection site
URL
http://www.bremenhealthcare.com/BuildPageC.asp?IFacID=156&PageID=H
Description
Kindred Bremen Health Care Center
URL
http://www.miamijewishhealthsystems.org
Description
Miami Jewish Home & Hospital will be a data collection site
URL
http://www.fairparkhc.com/BuildPageC.asp?IFacID=77&PageID=H
Description
Kindred Fairpark Health Care Center is a data collection site
URL
http://www.loudonhealthcare.com/BuildPageC.asp?IFacID=80&PageID=H
Description
Kindred Loudon Healthcare Center is a data collection site
URL
http://www.bremenhealthcare.com
Description
Related Info
URL
http://www.miamijewishhealthsystems.org/
Description
Related Info
Learn more about this trial
Pressure Ulcer Prevention: Turning for Ulcer Reduction
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