<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02996331</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00069413</org_study_id>
    <secondary_id>1R01NR016001-01A1</secondary_id>
    <nct_id>NCT02996331</nct_id>
  </id_info>
  <brief_title>Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors</brief_title>
  <official_title>Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether repositioning frequency can be extended for&#xD;
      nursing home (NH) residents who are low, moderate, and high risk for pressure ulcer (PrU)&#xD;
      development. The investigators will also determine how changes in medical severity interact&#xD;
      with changes in risk level and repositioning schedule to predict PrU development. This study&#xD;
      will advance knowledge about repositioning frequency and clinically assessed PrU risk-level&#xD;
      in relation to medical severity. Outcomes of this research will contribute to future&#xD;
      guidelines for more precise preventive nursing practices and refinement of PrU prevention&#xD;
      guidelines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this 9 nursing homes (NH) cluster randomized study is to determine whether&#xD;
      repositioning frequency can be extended for NH residents who are low, moderate, and high risk&#xD;
      for pressure ulcer (PrU) development and on visco-elastic (VE) high-density foam&#xD;
      support-surfaces without compromising PrU incidence. The investigators will also determine&#xD;
      how changes in medical severity interact with changes in risk level and repositioning&#xD;
      schedule to predict PrU development. PrUs result primarily from pressure over bony&#xD;
      prominences that occlude blood flow to tissues. Current PrU prevention protocols recommend&#xD;
      repositioning moderate, high, and severe risk residents a minimum of every 2 hours. The&#xD;
      investigators propose to include low risk residents because studies suggest they too develop&#xD;
      PrUs. New pressure redistribution mattresses may make 2 hour repositioning unnecessary, but&#xD;
      optimal time between repositioning remains unclear. Aims are 1) determine differences in&#xD;
      incidence of new PrUs in NH residents (low, moderate, high risk level) using VE surfaces and&#xD;
      repositioned at 2, 3, and 4 hour frequencies; and 2) determine how medical severity&#xD;
      components (measured by a modified Comprehensive Severity Index), changes in clinically&#xD;
      assessed risk-level (low, moderate, high as measured by Braden Scale), repositioning&#xD;
      schedule, and their interactions are associated with PrU development; and an Exploratory Aim:&#xD;
      Evaluate PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4&#xD;
      hour by: 1) comparing the intervention resource costs (VE surfaces, Leaf service/sensor use,&#xD;
      fixed and variable labor costs for training and repositioning) and incremental&#xD;
      cost-effectiveness ratio of cost per % reduction in PrUs, and 2) exploring staff and resident&#xD;
      satisfaction with intervention approach. The investigators will randomly assign each NH to&#xD;
      one of 3 study arms (2, 3, 4 hour) while providing standard nursing care. Leaf Patient&#xD;
      Monitoring System will be used with sensor worn continuously to monitor repositioning.&#xD;
      Periodic safety and care checks will be performed to ensure skin integrity. Residents&#xD;
      admitted to study NHs for at least 3 days during the 6 week intervention, without an existing&#xD;
      PrU, not using a specialty support surface, and of low, moderate, or high risk for PrU&#xD;
      development will be included in analysis based on intention to treat. The outcome, no&#xD;
      difference in PrU incidence, will determine whether repositioning frequency can be extended&#xD;
      for low, moderate, high risk residents. Medical severity components and clinically assessed&#xD;
      risk level will be examined for assessment to assessment change in relation to PrU&#xD;
      development, thus identifying severity components associated with new PrUs. Data will be&#xD;
      monitored by investigators daily. Data analysis and management will be performed by HSIR. NH&#xD;
      staff and resident satisfaction with the intervention approach will be explored using focus&#xD;
      groups. This study will advance knowledge about repositioning frequency and clinically&#xD;
      assessed PrU risk-level in relation to medical severity. Outcomes of this research will&#xD;
      contribute to future guidelines for more precise preventive nursing practices and refinement&#xD;
      of PrU prevention guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 16, 2017</start_date>
  <completion_date type="Actual">October 11, 2019</completion_date>
  <primary_completion_date type="Actual">October 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine differences in PrU Incidence among NH in study arms.</measure>
    <time_frame>4 weeks</time_frame>
    <description>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 &gt;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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine how medical severity components, changes in clinically assessed risk level, repositioning schedule, and their interactions are associated with development of PrUs.</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate cost-effectiveness of PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4 hour intervals.</measure>
    <time_frame>4 weeks</time_frame>
    <description>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 &amp; 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 &amp; 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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2113</enrollment>
  <condition>Pressure Ulcer</condition>
  <arm_group>
    <arm_group_label>2 hour arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants in this arm are assigned a 2-hour repositioning interval.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 hour arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in this arm are assigned a 3-hour repositioning interval.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4 hour arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in this arm are assigned a 4-hour repositioning interval.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2 hour repositioning</intervention_name>
    <description>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.</description>
    <arm_group_label>2 hour arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3 hour repositioning</intervention_name>
    <description>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.</description>
    <arm_group_label>3 hour arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>4 hour repositioning</intervention_name>
    <description>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.</description>
    <arm_group_label>4 hour arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NH residents for a minimum of 3 days who use a VE-surface mattress, are without PrUs&#xD;
             and are clinically assessed as low, moderate, or high risk for new PrU development&#xD;
             will participate in their respective NH-wide repositioning frequency protocol.&#xD;
&#xD;
          -  Participants will include residents at the time of study initiation and any newly&#xD;
             admitted residents during the 6-week study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newly admitted residents (less than 3 days)&#xD;
&#xD;
          -  resident has been diagnosed with pre-existing pressure ulcer&#xD;
&#xD;
          -  PrU Risk is severe (Braden score &lt;= 9)&#xD;
&#xD;
          -  the resident is cared for on a specialty bed (such as a bariatric bed)&#xD;
&#xD;
          -  &quot;do not turn&quot; orders are present&#xD;
&#xD;
          -  Allergy to adhesive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tracey Yap, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quinnipiac Valley Center</name>
      <address>
        <city>Wallingford</city>
        <state>Connecticut</state>
        <zip>06492</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulcer</keyword>
  <keyword>Pressure Ulcer</keyword>
  <keyword>Pathologic Processes</keyword>
  <keyword>Skin Ulcer</keyword>
  <keyword>Skin Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996331
org study id: PRO00069413
secondary id: 1R01NR016001-01A1
nct id: NCT02996331
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Determine differences in PrU Incidence among NH in study arms.
time frame: 4 weeks
description: 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.
measure: 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
description: 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.
measure: Evaluate cost-effectiveness of PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4 hour intervals.
time frame: 4 weeks
description: 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.
arm group label: 2 hour arm
arm group type: Active Comparator
description: All participants in this arm are assigned a 2-hour repositioning interval.
arm group label: 3 hour arm
arm group type: Experimental
description: All participants in this arm are assigned a 3-hour repositioning interval.
arm group label: 4 hour arm
arm group type: Experimental
description: All participants in this arm are assigned a 4-hour repositioning interval.
intervention type: Other
intervention name: 2 hour repositioning
description: 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.
arm group label: 2 hour arm
intervention type: Other
intervention name: 3 hour repositioning
description: 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.
arm group label: 3 hour arm
intervention type: Other
intervention name: 4 hour repositioning
description: 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.
arm group label: 4 hour arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tracey Yap, PhD, RN
role: Principal Investigator
affiliation: Duke University School of Nursing
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Ulcer
sharing ipd: No