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Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors

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ClinicalTrials.gov Identifier: NCT02996331
Recruitment Status : Enrolling by invitation
First Posted : December 19, 2016
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to determine whether repositioning frequency can be extended for nursing home (NH) residents who are low, moderate, and high risk for pressure ulcer (PrU) development. The investigators will also determine how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development. This study will advance knowledge about repositioning frequency and clinically assessed PrU risk-level in relation to medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Other: 2 hour repositioning Other: 3 hour repositioning Other: 4 hour repositioning Not Applicable

Detailed Description:
The purpose of this 9 nursing homes (NH) cluster randomized study is to determine whether repositioning frequency can be extended for NH residents who are low, moderate, and high risk for pressure ulcer (PrU) development and on visco-elastic (VE) high-density foam support-surfaces without compromising PrU incidence. The investigators will also determine how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development. PrUs result primarily from pressure over bony prominences that occlude blood flow to tissues. Current PrU prevention protocols recommend repositioning moderate, high, and severe risk residents a minimum of every 2 hours. The investigators propose to include low risk residents because studies suggest they too develop PrUs. New pressure redistribution mattresses may make 2 hour repositioning unnecessary, but optimal time between repositioning remains unclear. Aims are 1) determine differences in incidence of new PrUs in NH residents (low, moderate, high risk level) using VE surfaces and repositioned at 2, 3, and 4 hour frequencies; and 2) determine how medical severity components (measured by a modified Comprehensive Severity Index), changes in clinically assessed risk-level (low, moderate, high as measured by Braden Scale), repositioning schedule, and their interactions are associated with PrU development; and an Exploratory Aim: Evaluate PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4 hour by: 1) comparing the intervention resource costs (VE surfaces, Leaf service/sensor use, fixed and variable labor costs for training and repositioning) and incremental cost-effectiveness ratio of cost per % reduction in PrUs, and 2) exploring staff and resident satisfaction with intervention approach. The investigators will randomly assign each NH to one of 3 study arms (2, 3, 4 hour) while providing standard nursing care. Leaf Patient Monitoring System will be used with sensor worn continuously to monitor repositioning. Periodic safety and care checks will be performed to ensure skin integrity. Residents admitted to study NHs for at least 3 days during the 6 week intervention, without an existing PrU, not using a specialty support surface, and of low, moderate, or high risk for PrU development will be included in analysis based on intention to treat. The outcome, no difference in PrU incidence, will determine whether repositioning frequency can be extended for low, moderate, high risk residents. Medical severity components and clinically assessed risk level will be examined for assessment to assessment change in relation to PrU development, thus identifying severity components associated with new PrUs. Data will be monitored by investigators daily. Data analysis and management will be performed by HSIR. NH staff and resident satisfaction with the intervention approach will be explored using focus groups. This study will advance knowledge about repositioning frequency and clinically assessed PrU risk-level in relation to medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Active Comparator: 2 hour arm
All participants in this arm are assigned a 2-hour repositioning interval.
Other: 2 hour repositioning
Current PrU prevention protocols recommend repositioning moderate, high, and severe risk residents a minimum of every 2 hours. We propose to include low risk residents because studies suggest they too develop PrUs. New pressure redistribution mattresses may make 2 hour repositioning unnecessary, but optimal time between repositioning remains unclear. Aim is to determine differences in incidence of new PrUs in NH residents (low, moderate, high risk level) using VE surfaces and repositioned at 2, 3, and 4 hour frequencies.

Experimental: 3 hour arm
All participants in this arm are assigned a 3-hour repositioning interval.
Other: 3 hour repositioning
It is expected that repositioning frequency can be extended for NH residents who are low, moderate, and high risk for pressure ulcer (PrU) development and on visco-elastic (VE) high-density foam support-surfaces without compromising PrU incidence. This intervention will include a 3 hour repositioning interval.

Experimental: 4 hour arm
All participants in this arm are assigned a 4-hour repositioning interval.
Other: 4 hour repositioning
It is expected that repositioning frequency can be extended for NH residents who are low, moderate, and high risk for pressure ulcer (PrU) development and on visco-elastic (VE) high-density foam support-surfaces without compromising PrU incidence. This intervention will include a 4 hour repositioning interval.




Primary Outcome Measures :
  1. Determine differences in PrU Incidence among NH in study arms. [ Time Frame: 4 weeks ]
    Determine differences in the incidence of new PrUs in NH residents at low, moderate, and high risk using VE surfaces and repositioned at 2, 3, or 4 hour frequencies, in nine randomly assigned NHs over a 4-week period. We hypothesize that there will be no significant difference in PrU incidence between the 3 treatment arms in the study using three risk level groups: high risk (Braden Scale Score, 10-12), moderate risk (Braden Scale Score, 13-14), and low risk (Braden Scores >14). The hypothesis of no group-difference will be tested by examining whether the 95% confidence intervals of the rates of PrU and the 2-hour repositioning overlap. If they do, the hypothesis for no group-difference will be confirmed. Cumulative Incidence rate = [(# of residents with 1 or more new PrUs during intervention period) ÷ (# of residents participating in intervention for 3 or more days)] x 100; calculated for the full 4-week intervention period.


Secondary Outcome Measures :
  1. Determine how medical severity components, changes in clinically assessed risk level, repositioning schedule, and their interactions are associated with development of PrUs. [ Time Frame: 4 weeks ]
    Calculated severity score resulting from distillation of over 2,000 potential elements using the modified Comprehensive Severity Index (CSI) risk adjustment system. The more abnormal the signs/symptoms, the higher the severity score: Level 1 (normal to mild) - Level 4 (catastrophic, life-threatening, or likely to result in organ failure). PrU development will be examined and the PrU incidence rate will be modeled as a binary outcome. Additionally, generalized estimating equations (GEEs) will be used with model fit assessed using the quasi-likelihood information criterion (QIC). Robust standard errors, clustered at the facility level, will be employed to account for covariance among residents within facilities over time. To test the robustness of models, non-linear mixed models using PROC GLIMMIX will be employed as another option for modeling the data.

  2. Evaluate cost-effectiveness of PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4 hour intervals. [ Time Frame: 4 weeks ]
    Comparing the intervention resource costs and incremental cost-effectiveness ratio of cost per % reduction in PrUs. Intervention cost will include labor cost, such as training time multiplied by wage & fringe rates of training participants and number of repositionings for each NH and study arm and time to conduct repositioning collected by Leaf system; multiplied by nurse wage & fringe rate. Non-labor cost inputs will include market prices paid fully depreciated over their respective useful life will be used to calculate daily equipment cost rates. Intervention cost by NH and study arm and incremental cost-effectiveness ratios (ICERs) will be calculated and compared for cost per % reduction in PrUs. Sensitivity analysis will be conducted with the range of observed repositioning times, nurse salaries, and market prices for non-labor inputs to assess the robustness of the ICERs and their sensitivity to labor and non-labor input prices.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • NH residents for a minimum of 3 days who use a VE-surface mattress, are without PrUs and are clinically assessed as low, moderate, or high risk for new PrU development will participate in their respective NH-wide repositioning frequency protocol.
  • Participants will include residents at the time of study initiation and any newly admitted residents during the 6-week study period.

Exclusion Criteria:

  • Newly admitted residents (less than 3 days)
  • resident has been diagnosed with pre-existing pressure ulcer
  • PrU Risk is severe (Braden score <= 9)
  • the resident is cared for on a specialty bed (such as a bariatric bed)
  • "do not turn" orders are present
  • Allergy to adhesive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996331


Locations
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United States, Connecticut
Quinnipiac Valley Center
Wallingford, Connecticut, United States, 06492
Sponsors and Collaborators
Duke University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Tracey Yap, PhD, RN Duke University School of Nursing

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02996331     History of Changes
Other Study ID Numbers: PRO00069413
1R01NR016001-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases