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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00665535 |
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 2, 3 or 4 hours and participants at high risk (Braden Scores 10-12) turned every 2 or 3 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 III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Preventing Pressure Ulcers: A Multi-Site RCT in Nursing Facilities |
Estimated Enrollment: | 900 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | March 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 or 3 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
|
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-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 (900) 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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Participants will:
Exclusion Criteria:
Contact: Mary Pat Rapp, PhD | 281-794-7345 | Mary.P.Rapp@uth.tmc.edu |
Contact: Nancy Bergstrom, PhD | 713-500-9920 | Nancy.Bergstrom@uth.tmc.edu |
United States, Florida | |
Palatka Health Care Center | Recruiting |
Palatka, Florida, United States, 32177 | |
Contact: Patricia Freeman 386-325-0173 freemphcc@bellsouth.net | |
Contact: Marcia Lyles 386-325-0173 | |
Principal Investigator: Marcia Lyles | |
United States, New York | |
Gurwin Jewish Nursing and Rehabilitation Center | Recruiting |
Commack, New York, United States, 11725-4403 | |
Contact: Joanne Parisi 631-715-2577 jparisi@gurwin.org | |
Contact: Jean Marie Kineiko 386-715-2410 jkineiko@gurwin.org | |
Principal Investigator: Joanne Parisi | |
Monroe Community Hospital | Recruiting |
Rochester, New York, United States, 14620 | |
Contact: Ruth Dorrough 585-760-6323 rdorrough@monroehosp.org | |
Contact: Jane Banzhaf 585-760-6500 JBanzhaf@monroehosp.org | |
Principal Investigator: Ruth Dorrough | |
United States, Ohio | |
Hennis Care Center | Recruiting |
Dover, Ohio, United States, 44622 | |
Contact: Anita Peffer, BS 330-364-8849 apeffer@henniscarecentre.com | |
Contact: Rhonda Arter 330-364-8849 rarter@henniscarecenter.com | |
Principal Investigator: Anita Peffer, BSN |
Principal Investigator: | Nancy Bergstrom, PhD | The University of Texas Health Science Center, Houston |
Principal Investigator: | Susan Horn, PhD | ISIS, Salt Lake City, UT |
Responsible Party: | University of Texas-Houston ( Nancy I. Bergstrom, Trumble Professor of Aging Research ) |
Study ID Numbers: | 1R011NR009680-01A1 |
Study First Received: | April 22, 2008 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00665535 |
Health Authority: | United States: Institutional Review Board |
Pressure ulcers Nursing facilities Elderly At risk for pressure ulcers |
Skin Diseases Ulcer Skin Ulcer Pressure Ulcer |
Pathologic Processes |