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.
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
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
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 group | Role | What they receive |
|---|---|---|
| 2. High Risk | Other | High 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 Risk | Other | Moderate 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.
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.
- First posted24 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR), National Institute on Aging (NIA), Ontario Ministry of Health and Long Term Care, Toronto Health Economic Technology Assessment collaborative (THETA)
- Responsible party
- Principal investigator, Nancy Bergstrom, The University of Texas Health Science Center, Houston
- Investigators
- Nancy Bergstrom, PhD, Principal investigator, The University of Texas Health Science Center, HoustonSusan Horn, PhD, Principal investigator, ISIS, Salt Lake City, UT
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 26066791Omolayo 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Pressure Ulcers: A Multi-site RCT in Nursing Facilities
- ClinicalTrials.gov ID
- NCT00665535
- Acronym / sponsor ID
- TURN / 1R011NR009680-01A1
- Conditions
- Pressure Ulcers
- Keywords
- Pressure ulcers, Nursing facilities, Elderly, At risk for pressure ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 967 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR), National Institute on Aging (NIA), Ontario Ministry of Health and Long Term Care, Toronto Health Economic Technology Assessment collaborative (THETA)
- Study start
- Mar 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2. High Risk | Other | Procedure: Turning or repositioning scheduleHigh risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 10-12) |
| 1. Moderate Risk | Other | Procedure: Turning or repositioning scheduleModerate risk for pressure ulcers according to the Braden Scale for Predicting Pressure Sore Risk (Score 13 and 14) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turning or repositioning scheduleTurning schedule randomly assigned at 2, 3, or 4 hours | Procedure or surgery | 1. Moderate Risk |
| Turning or repositioning scheduleTurning schedule randomly assigned at 2, 3 or 4 hours | Procedure or surgery | 2. High Risk |
Primary outcome
Pressure ulcers, present (stage)or absent
Time frame: End of 3rd week or conclusion of participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Derived from this study: PubMed 26066791Yap 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.
- Derived from this study: PubMed 23426413Omolayo 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.
- Home of the Braden Scale and source of official copies of the tool and the location for obtaining permission to use the tool.Link provided by the sponsor.
- Home of the National Pressure Ulcer Advisory Panel with information regarding staging and policies regarding pressure ulcersLink provided by the sponsor.
- Home page of the Wound Ostomy and Continence Nurses Organization, the experts in wound healing.Link provided by the sponsor.
- Hennis Care Center of Dover, Ohio is a data collection siteLink provided by the sponsor.
- Gurwin Jewish Nursing and Rehabilitation Center, Commack, NY, is a data collection siteLink provided by the sponsor.
- Monro Community Hospital, Rochester, NY, is a data collection sitesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Bergstrom, PhD principal investigator
The University of Texas Health Science Center, Houston
Susan Horn, PhD principal investigator
ISIS, Salt Lake City, UT
26 sites in 2 countries: see every site and its status.
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.