Clinical trial NCT00665535: Pressure Ulcer Prevention: Turning for Ulcer Reduction
Official title: Preventing Pressure Ulcers: A Multi-site RCT in Nursing Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pressure Ulcers
Keywords: Pressure ulcers
Nursing facilities
Elderly
At risk for pressure ulcers
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
name: National Institute on Aging (NIA)
name: Ontario Ministry of Health and Long Term Care
name: Toronto Health Economic Technology Assessment collaborative (THETA)
First posted: 2008-04-24
Enrollment: 967
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Pressure ulcers, present (stage)or absent
timeFrame: End of 3rd week or conclusion of participation
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glencroft Care Center
state: Arizona
city: Loma Linda
country: United States
facility: Linda Valley Nursing Facility
state: California
city: Los Angeles
country: United States
facility: Garden Crest Convalescent Hospital
state: California
city: Jacksonville
country: United States
facility: St. Catherine Laboure Manor
state: Florida
city: Miami
country: United States
facility: Miami Jewish Home & Hospital
state: Florida
city: Palatka
country: United States
facility: Palatka Health Care Center
state: Florida
city: Bremen
country: United States
facility: Kindred Bremen Health Care Center
state: Indiana
city: Canton
country: United States
facility: Tower Hill Center for Health and Rehabilitation
state: Massachusetts
city: Commack
country: United States
facility: Gurwin Jewish Nursing and Rehabilitation Center
state: New York
city: Rochester
country: United States
facility: Monroe Community Hospital
state: New York
city: Greensboro
country: United States
facility: BlumenthalJewish Nursing and Rehabilitation
state: North Carolina
city: Dover
country: United States
facility: Hennis Care Center
state: Ohio
city: Sidney
country: United States
facility: Dorothy Love Retirement Community
state: Ohio
city: Willoughby
country: United States
facility: Fairmount at aBreckenridge Village
state: Ohio
city: Youngstown
country: United States
facility: Park Vista Retirement Community
state: Ohio
city: Columbia
country: United States
facility: Signature HealthCare of Columbia
state: Tennessee
city: Loudon
country: United States
facility: Kindred Loudon Healthcare Center
state: Tennessee
city: Maryville
country: United States
facility: Kindred Fairpark Health Care Center
state: Tennessee
city: Maryville
country: United States
facility: Asbury Place Maryville
state: Tennessee
city: East Missassauga
country: Canada
facility: Tyndall Nursing Home
state: Ontario
city: Mississauga
country: Canada
facility: Malton Village Long Term Care Center
state: Ontario
city: Mississauga
country: Canada
facility: Specialty Care of Mississauga Road
state: Ontario
city: Scarborough
country: Canada
facility: Yee Hong Scarborough
state: Ontario
city: Scarborough
country: Canada
facility: Shepherd Lodge
state: Ontario
city: Toronto
country: Canada
facility: Leisure World Lawrence
state: Ontario
city: Woodbridge
country: Canada
facility: Villa Leonardo Gambin Specialty Care
state: Ontario
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nancy Bergstrom, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ISIS, Salt Lake City, UT
name: Susan Horn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.