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Pressure UlcersPhase 3TURNNCT00665535

Pressure Ulcer Prevention: Turning for Ulcer Reduction

A Phase 3 study testing Turning or repositioning schedule in people with Pressure Ulcers, run by The University of Texas Health Science Center, Houston at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Pressure Ulcers
What is being tested?
Turning or repositioning schedule
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
967 participants
Where
26 sitesin 2 countries
Study dates
Mar 2008to Jun 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States19 sites
  • Kindred Bremen Health Care Center

    Bremen, Indiana, 46506

  • Tower Hill Center for Health and Rehabilitation

    Canton, Massachusetts, 02021

  • Signature HealthCare of Columbia

    Columbia, Tennessee, 38401

  • Gurwin Jewish Nursing and Rehabilitation Center

    Commack, New York, 11725-4403

  • Hennis Care Center

    Dover, Ohio, 44622

  • Glencroft Care Center

    Glendale, Arizona, 85302

  • BlumenthalJewish Nursing and Rehabilitation

    Greensboro, North Carolina, 27455

  • St. Catherine Laboure Manor

    Jacksonville, Florida, 32204

  • Linda Valley Nursing Facility

    Loma Linda, California, 92354

  • Garden Crest Convalescent Hospital

    Los Angeles, California, 90026

  • Kindred Loudon Healthcare Center

    Loudon, Tennessee, 37774

  • Kindred Fairpark Health Care Center

    Maryville, Tennessee, 37802

  • Asbury Place Maryville

    Maryville, Tennessee, 37804

  • Miami Jewish Home & Hospital

    Miami, Florida, 33137

  • Palatka Health Care Center

    Palatka, Florida, 32177

  • Monroe Community Hospital

    Rochester, New York, 14620

  • Dorothy Love Retirement Community

    Sidney, Ohio, 45365

  • Fairmount at aBreckenridge Village

    Willoughby, Ohio, 44504

  • Park Vista Retirement Community

    Youngstown, Ohio, 44094

Other trials in United States

Canada7 sites
  • Tyndall Nursing Home

    East Missassauga, Ontario, L4W 1K3

  • Malton Village Long Term Care Center

    Mississauga, Ontario, L4T4M1

  • Specialty Care of Mississauga Road

    Mississauga, Ontario, L5M 7C3

  • Yee Hong Scarborough

    Scarborough Village, Ontario, M1S 5T7

  • Shepherd Lodge

    Scarborough Village, Ontario, M1T 3K9

  • Leisure World Lawrence

    Toronto, Ontario, M9N 3V4

  • Villa Leonardo Gambin Specialty Care

    Woodbridge, Ontario, L4L 9T3

Other trials in Canada

About this study

Official title: Preventing Pressure Ulcers: A Multi-site RCT in Nursing Facilities

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.

Read the 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
Being tested
Turning or repositioning schedule
Keywords
Pressure ulcers, Nursing facilities, Elderly, At risk for pressure ulcers
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Turning or repositioning scheduleProcedure or surgery

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

  • Turning or repositioning scheduleProcedure or surgery

    Turning schedule randomly assigned at 2, 3 or 4 hours

Study groups in NCT00665535
Study groupRoleWhat they receive
2. High RiskOtherHigh risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12)
Receives: Procedure: Turning or repositioning schedule
1. Moderate RiskOtherModerate risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 13 and 14)
Receives: Procedure: Turning or repositioning schedule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure ulcers, present (stage)or absent

    Measured: End of 3rd week or conclusion of participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
967 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00665535
Sponsor's protocol ID
1R011NR009680-01A1
Acronym
TURN
Status last verified
Mar 2012
First submitted
22 Apr 2008
Last updated
21 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26066791
  • 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.

    PubMed 23426413

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Turning or repositioning schedule in people with Pressure Ulcers, run by The University of Texas Health Science Center, Houston at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure ulcers, present (stage)or absent (time frame: End of 3rd week or conclusion of participation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00665535, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.

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