<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/NCT03303664</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00022455</org_study_id>
    <nct_id>NCT03303664</nct_id>
  </id_info>
  <brief_title>Inpatient Multimodal Path to RecOVEry</brief_title>
  <acronym>IMPROVE</acronym>
  <official_title>Inpatient Multimodal Path to RecOVEry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</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 goal of the proposed study is to develop and implement a comprehensive strategy to&#xD;
      address pain management in the inpatient setting while appropriately managing pain and&#xD;
      optimizing patient safety in the inpatient setting. This strategy involves developing a new&#xD;
      health Information Technology tool in the Omnicell and electronic medical record,&#xD;
      implementing a &quot;menu&quot; of pain management and relaxation strategies, and developing&#xD;
      educational materials for staff and patients to change the culture of pain management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the proposed study is to develop and implement a comprehensive strategy to&#xD;
      address pain management in the inpatient setting while appropriately managing pain and&#xD;
      optimizing patient safety in the inpatient setting. This strategy involves developing a new&#xD;
      health Information Technology tool in the Omnicell and electronic medical record,&#xD;
      implementing a &quot;menu&quot; of pain management and relaxation strategies, and developing&#xD;
      educational materials for staff and patients to change the culture of pain management.&#xD;
&#xD;
      This intervention will be implemented throughout CHS hospitals, using a stepped wedge design&#xD;
      to guide rollout. The initial pilot will be conducted in the trauma inpatient units at&#xD;
      Carolinas Medical Center. All patients admitted to the two primary trauma units (11A and 11&#xD;
      Tower) during the pilot study period will be included in the evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    System-wide implementation of intervention prevented randomized trial design&#xD;
  </why_stopped>
  <start_date type="Actual">July 11, 2017</start_date>
  <completion_date type="Actual">February 26, 2018</completion_date>
  <primary_completion_date type="Actual">February 26, 2018</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>Use of Opioid Overdose Reversal Treatment</measure>
    <time_frame>Patient's entire length of stay in the hospital, up to 3 months</time_frame>
    <description>Incidence of administration of opioid reversal agent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Patient's entire length of stay in the hospital, up to 3 months</time_frame>
    <description>Average daily pain scores (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oversedation without naloxone</measure>
    <time_frame>Patient's entire length of stay in the hospital, up to 3 months</time_frame>
    <description>Incidence of patient oversedation (Pasero &gt; 2 or associated diagnosis code)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multimodal Therapy</measure>
    <time_frame>Patient's entire length of stay in the hospital, up to 3 months</time_frame>
    <description>Percentage of patients receiving multimodal pain management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Daily MME</measure>
    <time_frame>Patient's entire length of stay in the hospital, up to 3 months</time_frame>
    <description>Morphine Milligram Equivalent Dosing for Opioid Medications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pain</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>IMPROVE Protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is composed of 4 parts: 1) a multidisciplinary team that recommends, develops, approves, monitors the components of the intervention and training? 2) monitoring of medication sedation risk using established scale 3) restriction of medication dispensing via enhanced technology 4) health professional training on multimodality pain management including complementary and alternative therapies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment of patients in the usual manner based on their diagnosis and resources available at that site.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IMPROVE Protocol</intervention_name>
    <description>Comprehensive pain management protocol</description>
    <arm_group_label>IMPROVE Protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients treated in facility as inpatient during the study period will be included&#xD;
             in the analysis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not admitted to facility during the study period will be excluded from the&#xD;
             analysis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph R Hsu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carolinas Healthcare System - Stanly</name>
      <address>
        <city>Albemarle</city>
        <state>North Carolina</state>
        <zip>28001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - Mercy</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - Pineville</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - University</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - NorthEast</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - Kings Mountain</name>
      <address>
        <city>Kings Mountain</city>
        <state>North Carolina</state>
        <zip>28086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - Lincoln</name>
      <address>
        <city>Lincolnton</city>
        <state>North Carolina</state>
        <zip>28092</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - Union</name>
      <address>
        <city>Monroe</city>
        <state>North Carolina</state>
        <zip>28112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - Blue Ridge</name>
      <address>
        <city>Morganton</city>
        <state>North Carolina</state>
        <zip>28655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - Cleveland</name>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <zip>28150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System - Anson</name>
      <address>
        <city>Wadesboro</city>
        <state>North Carolina</state>
        <zip>28170</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>opioid</keyword>
  <keyword>inpatient</keyword>
  <keyword>pain</keyword>
  <keyword>multimodal</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be made available to other researchers.</ipd_description>
  </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/NCT03303664
org study id: Pro00022455
nct id: NCT03303664
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of the proposed study is to develop and implement a comprehensive strategy to
      address pain management in the inpatient setting while appropriately managing pain and
      optimizing patient safety in the inpatient setting. This strategy involves developing a new
      health Information Technology tool in the Omnicell and electronic medical record,
      implementing a "menu" of pain management and relaxation strategies, and developing
      educational materials for staff and patients to change the culture of pain management.
The goal of the proposed study is to develop and implement a comprehensive strategy to
      address pain management in the inpatient setting while appropriately managing pain and
      optimizing patient safety in the inpatient setting. This strategy involves developing a new
      health Information Technology tool in the Omnicell and electronic medical record,
      implementing a "menu" of pain management and relaxation strategies, and developing
      educational materials for staff and patients to change the culture of pain management.

      This intervention will be implemented throughout CHS hospitals, using a stepped wedge design
      to guide rollout. The initial pilot will be conducted in the trauma inpatient units at
      Carolinas Medical Center. All patients admitted to the two primary trauma units (11A and 11
      Tower) during the pilot study period will be included in the evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Use of Opioid Overdose Reversal Treatment
time frame: Patient's entire length of stay in the hospital, up to 3 months
description: Incidence of administration of opioid reversal agent
measure: Pain
time frame: Patient's entire length of stay in the hospital, up to 3 months
description: Average daily pain scores (VAS)
measure: Oversedation without naloxone
time frame: Patient's entire length of stay in the hospital, up to 3 months
description: Incidence of patient oversedation (Pasero > 2 or associated diagnosis code)
measure: Multimodal Therapy
time frame: Patient's entire length of stay in the hospital, up to 3 months
description: Percentage of patients receiving multimodal pain management
measure: Average Daily MME
time frame: Patient's entire length of stay in the hospital, up to 3 months
description: Morphine Milligram Equivalent Dosing for Opioid Medications
arm group label: IMPROVE Protocol
arm group type: Experimental
description: The intervention is composed of 4 parts: 1) a multidisciplinary team that recommends, develops, approves, monitors the components of the intervention and training? 2) monitoring of medication sedation risk using established scale 3) restriction of medication dispensing via enhanced technology 4) health professional training on multimodality pain management including complementary and alternative therapies.
arm group label: Usual Care
arm group type: No Intervention
description: Treatment of patients in the usual manner based on their diagnosis and resources available at that site.
intervention type: Other
intervention name: IMPROVE Protocol
description: Comprehensive pain management protocol
arm group label: IMPROVE Protocol
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Joseph R Hsu, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: No IPD will be made available to other researchers.