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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
| National Institute on Aging (NIA) | NIH |
| Ontario Ministry of Health and Long Term Care |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2. High Risk | Other | High risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12) |
|
| 1. Moderate Risk | Other | Moderate risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 13 and 14) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turning or repositioning schedule | Procedure | Turning schedule randomly assigned at 2, 3, or 4 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pressure ulcers, present (stage)or absent | End of 3rd week or conclusion of participation |
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Inclusion Criteria: Participants will:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Bergstrom, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Susan Horn, PhD | ISIS, Salt Lake City, UT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glencroft Care Center | Glendale | Arizona | 85302 | United States | ||
| Linda Valley Nursing Facility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26066791 | Derived | 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. | |
| 23426413 | Derived | 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. |
| Label | URL |
|---|---|
| Home of the Braden Scale and source of official copies of the tool and the location for obtaining permission to use the tool. | View source |
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| OTHER_GOV |
| Toronto Health Economic Technology Assessment collaborative (THETA) | UNKNOWN |
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| Turning or repositioning schedule | Procedure | Turning schedule randomly assigned at 2, 3 or 4 hours |
|
| Loma Linda |
| California |
| 92354 |
| United States |
| Garden Crest Convalescent Hospital | Los Angeles | California | 90026 | United States |
| St. Catherine Laboure Manor | Jacksonville | Florida | 32204 | United States |
| Miami Jewish Home & Hospital | Miami | Florida | 33137 | United States |
| Palatka Health Care Center | Palatka | Florida | 32177 | United States |
| Kindred Bremen Health Care Center | Bremen | Indiana | 46506 | United States |
| Tower Hill Center for Health and Rehabilitation | Canton | Massachusetts | 02021 | United States |
| Gurwin Jewish Nursing and Rehabilitation Center | Commack | New York | 11725-4403 | United States |
| Monroe Community Hospital | Rochester | New York | 14620 | United States |
| BlumenthalJewish Nursing and Rehabilitation | Greensboro | North Carolina | 27455 | United States |
| Hennis Care Center | Dover | Ohio | 44622 | United States |
| Dorothy Love Retirement Community | Sidney | Ohio | 45365 | United States |
| Fairmount at aBreckenridge Village | Willoughby | Ohio | 44504 | United States |
| Park Vista Retirement Community | Youngstown | Ohio | 44094 | United States |
| Signature HealthCare of Columbia | Columbia | Tennessee | 38401 | United States |
| Kindred Loudon Healthcare Center | Loudon | Tennessee | 37774 | United States |
| Kindred Fairpark Health Care Center | Maryville | Tennessee | 37802 | United States |
| Asbury Place Maryville | Maryville | Tennessee | 37804 | United States |
| Tyndall Nursing Home | East Missassauga | Ontario | L4W 1K3 | Canada |
| Malton Village Long Term Care Center | Mississauga | Ontario | L4T4M1 | Canada |
| Specialty Care of Mississauga Road | Mississauga | Ontario | L5M 7C3 | Canada |
| Yee Hong Scarborough | Scarborough Village | Ontario | M1S 5T7 | Canada |
| Shepherd Lodge | Scarborough Village | Ontario | M1T 3K9 | Canada |
| Leisure World Lawrence | Toronto | Ontario | M9N 3V4 | Canada |
| Villa Leonardo Gambin Specialty Care | Woodbridge | Ontario | L4L 9T3 | Canada |
| Home of the National Pressure Ulcer Advisory Panel with information regarding staging and policies regarding pressure ulcers | View source |
| Home page of the Wound Ostomy and Continence Nurses Organization, the experts in wound healing. | View source |
| Hennis Care Center of Dover, Ohio is a data collection site | View source |
| Gurwin Jewish Nursing and Rehabilitation Center, Commack, NY, is a data collection site | View source |
| Monro Community Hospital, Rochester, NY, is a data collection sites | View source |
| Specialty Care Mississauga Road, Mississauga, Ontario, Canada is a data collection site | View source |
| Villa Leonardo Gambin, Woodbridge, Ontario, Canada is a data collection site | View source |
| Fairmount at Breckenridge Village is a data collection site | View source |
| St. Catherine Laboure Manor is a data collection site | View source |
| Kindred Bremen Health Care Center | View source |
| Miami Jewish Home \& Hospital will be a data collection site | View source |
| Kindred Fairpark Health Care Center is a data collection site | View source |
| Kindred Loudon Healthcare Center is a data collection site | View source |
| Related Info | View source |
| Related Info | View source |
| Related Info | View source |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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