Pressure Ulcer Prevention: Turning for Ulcer Reduction (TURN)
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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 |
- 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 |
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| 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 | |
| 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 May 21, 2013