Pressure Ulcer Prevention: Turning for Ulcer Reduction

NCT ID: NCT00665535

Last Updated: 2012-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 967 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-06-30

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.

Conditions

Pressure Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

2. High Risk

High risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12)

Group Type: OTHER

Turning or repositioning schedule

Intervention Type: PROCEDURE

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)

Group Type: OTHER

Turning or repositioning schedule

Intervention Type: PROCEDURE

Turning schedule randomly assigned at 2, 3, or 4 hours

Interventions

Turning or repositioning schedule

Turning schedule randomly assigned at 2, 3, or 4 hours

Intervention Type: PROCEDURE

Turning or repositioning schedule

Turning schedule randomly assigned at 2, 3 or 4 hours

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

Toronto Health Economic Technology Assessment collaborative (THETA)

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Nancy Bergstrom

Trumble Professor of Aging Research & Director, Center on Aging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Bergstrom, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Susan Horn, PhD

Role: PRINCIPAL_INVESTIGATOR

ISIS, Salt Lake City, UT

Locations

Glencroft Care Center

Glendale, Arizona, United States

Linda Valley Nursing Facility

Loma Linda, California, United States

Garden Crest Convalescent Hospital

Los Angeles, California, United States

St. Catherine Laboure Manor

Jacksonville, Florida, United States

Miami Jewish Home & Hospital

Miami, Florida, United States

Palatka Health Care Center

Palatka, Florida, United States

Kindred Bremen Health Care Center

Bremen, Indiana, United States

Tower Hill Center for Health and Rehabilitation

Canton, Massachusetts, United States

Gurwin Jewish Nursing and Rehabilitation Center

Commack, New York, United States

Monroe Community Hospital

Rochester, New York, United States

BlumenthalJewish Nursing and Rehabilitation

Greensboro, North Carolina, United States

Hennis Care Center

Dover, Ohio, United States

Dorothy Love Retirement Community

Sidney, Ohio, United States

Fairmount at aBreckenridge Village

Willoughby, Ohio, United States

Park Vista Retirement Community

Youngstown, Ohio, United States

Signature HealthCare of Columbia

Columbia, Tennessee, United States

Kindred Loudon Healthcare Center

Loudon, Tennessee, United States

Kindred Fairpark Health Care Center

Maryville, Tennessee, United States

Asbury Place Maryville

Maryville, Tennessee, United States

Tyndall Nursing Home

East Missassauga, Ontario, Canada

Malton Village Long Term Care Center

Mississauga, Ontario, Canada

Specialty Care of Mississauga Road

Mississauga, Ontario, Canada

Yee Hong Scarborough

Scarborough Village, Ontario, Canada

Shepherd Lodge

Scarborough Village, Ontario, Canada

Leisure World Lawrence

Toronto, Ontario, Canada

Villa Leonardo Gambin Specialty Care

Woodbridge, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 26066791 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23426413 (View on PubMed)

Related Links

http://www.bradenscale.com

Home of the Braden Scale and source of official copies of the tool and the location for obtaining permission to use the tool.

http://www.npuap.org/

Home of the National Pressure Ulcer Advisory Panel with information regarding staging and policies regarding pressure ulcers

http://www.wocn.org/

Home page of the Wound Ostomy and Continence Nurses Organization, the experts in wound healing.

http://www.henniscarecentre.com/volunteers.htm

Hennis Care Center of Dover, Ohio is a data collection site

http://www.gurwin.org/

Gurwin Jewish Nursing and Rehabilitation Center, Commack, NY, is a data collection site

http://www.monroehosp.org/

Monro Community Hospital, Rochester, NY, is a data collection sites

http://www.specialty-care.com/index.php/mississauga-road

Specialty Care Mississauga Road, Mississauga, Ontario, Canada is a data collection site

http://www.specialty-care.com/index.php/villa-leonardo-gambin

Villa Leonardo Gambin, Woodbridge, Ontario, Canada is a data collection site

http://www.oprs.org/breckenridge_village/

Fairmount at Breckenridge Village is a data collection site

http://www.jaxhealth.com/AboutUs/default.asp?ENOrgID=B8AD2776B8C74351ABCD7349B0C8D30D

St. Catherine Laboure Manor is a data collection site

http://www.bremenhealthcare.com/BuildPageC.asp?IFacID=156&PageID=H

Kindred Bremen Health Care Center

http://www.miamijewishhealthsystems.org

Miami Jewish Home \& Hospital will be a data collection site

http://www.fairparkhc.com/BuildPageC.asp?IFacID=77&PageID=H

Kindred Fairpark Health Care Center is a data collection site

http://www.loudonhealthcare.com/BuildPageC.asp?IFacID=80&PageID=H

Kindred Loudon Healthcare Center is a data collection site

http://www.bremenhealthcare.com

Related Info

http://www.miamijewishhealthsystems.org/

Related Info

http://www.signaturehealthcarellc.com/Facility/FacilityInfo.aspx

Related Info

Other Identifiers

1R011NR009680-01A1

Identifier Type: -

Identifier Source: org_study_id