<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/NCT03771482</url>
  </required_header>
  <id_info>
    <org_study_id>190371</org_study_id>
    <nct_id>NCT03771482</nct_id>
  </id_info>
  <brief_title>Education of Providers on Prescribing Best Practices</brief_title>
  <official_title>Education of Providers on Prescribing Best Practices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      This study aims to evaluate the impact of spaced education, delivered via a smartphone&#xD;
      application, on provider prescribing patterns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As part of a medical center educational initiative at Vanderbilt University Medical Center&#xD;
      (VUMC), two educational modules will be sent to prescribing providers through either email or&#xD;
      short message service (SMS) text messaging. The first educational module consists of a set of&#xD;
      multiple choice questions concerning best practices for prescribing intravenous fluids in the&#xD;
      inpatient and perioperative setting. This module is based upon recent literature and&#xD;
      specifically derived from the results of the Isotonic Solutions and Major Adverse Renal&#xD;
      Events Trial (SMART) and Saline Against Lactated Ringer's or Plasma-Lyte in the Emergency&#xD;
      Department (SALT-ED) trial, both published in the New England Journal of Medicine in 2018 and&#xD;
      led by Vanderbilt investigators. Similarly, a second educational module concerning&#xD;
      evidence-based pain management and opioid prescribing practices will be distributed via email&#xD;
      or SMS text messaging.&#xD;
&#xD;
      Participants will receive one question per day. If the participant does not answer the&#xD;
      question correctly, they will receive the opportunity to attempt the question again after&#xD;
      reviewing evidence-based education. All questions have been curated and reviewed by a panel&#xD;
      of experts and piloted within VUMC for feasibility and acceptability. Key concepts are&#xD;
      repeated in each module and questions are strategically ordered throughout each module to&#xD;
      accomplish spaced education.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2019</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Median morphine milligram equivalents (MME) per opioid prescription</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting prescribing data for opioids from the electronic health records</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of orders for balanced intravenous (IV) fluid solutions (i.e. not normal saline)</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting prescribing data for intravenous fluids from the electronic health records</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chloride levels in patients receiving intravenous fluid orders from a provider enrolled in the study</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting chloride level data from the electronic health records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium levels in patients receiving intravenous fluid orders from a provider enrolled in the study</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting potassium level data from the electronic health records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Kidney Events by 30 days (MAKE 30) in patients receiving intravenous fluid orders from a provider enrolled in the study</measure>
    <time_frame>30 days</time_frame>
    <description>By extracting data from the electronic health records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay for patients receiving an intravenous fluid order or an opioid prescription from a provider enrolled in the study.</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting length of stay data from the electronic health records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the intensive care unit (ICU) for patients receiving an intravenous fluid order or an opioid prescription from a provider enrolled in the study</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting ICU length of stay from the electronic health records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median number of pills per prescription for patients receiving an opioid prescription from a provider enrolled in the study</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting medication data from the electronic health records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of opioid prescriptions (inpatient) that also had a scheduled (not pro re nata (PRN)) non-opioid (APAP, nonsteroidal anti-inflammatory drugs (NSAIDs), gamma-Aminobutyric acid (GABA), muscle relaxant, etc.)</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting medication data from the electronic health records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of opioid prescriptions (discharge) that also had a scheduled (not PRN) non-opioid (APAP, NSAIDs, GABA, muscle relaxant, etc.)</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting medication data from the electronic health records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Rapid Response Team calls (RRT s) indexed to the number of patients cared for per prescriber (evaluated by level of engagement of the learner with QuizTime)</measure>
    <time_frame>8 months</time_frame>
    <description>By extracting RRT calls from the electronic health records</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">369</enrollment>
  <condition>Education</condition>
  <arm_group>
    <arm_group_label>Opioid module first then fluid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The providers in this arm will first receive daily information and questions related to opioid use for eight weeks and then daily information and questions related to intravenous fluid prescribing for five weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluid module first then opioid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The providers in this arm will first receive daily information and questions related to intravenous fluid prescribing for five weeks and then daily information and questions related to opioid use for eight weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quiztime modules</intervention_name>
    <description>Text Messaging or Email system</description>
    <arm_group_label>Fluid module first then opioid</arm_group_label>
    <arm_group_label>Opioid module first then fluid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All inpatient prescribing providers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew McEvoy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Matthew McEvoy</investigator_full_name>
    <investigator_title>Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data dictionaries and individual participant data that underlie the results reported after de-identification will be available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>3 months after publication for 5 years</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.</ipd_access_criteria>
  </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/NCT03771482
org study id: 190371
nct id: NCT03771482
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the impact of spaced education, delivered via a smartphone
      application, on provider prescribing patterns.
As part of a medical center educational initiative at Vanderbilt University Medical Center
      (VUMC), two educational modules will be sent to prescribing providers through either email or
      short message service (SMS) text messaging. The first educational module consists of a set of
      multiple choice questions concerning best practices for prescribing intravenous fluids in the
      inpatient and perioperative setting. This module is based upon recent literature and
      specifically derived from the results of the Isotonic Solutions and Major Adverse Renal
      Events Trial (SMART) and Saline Against Lactated Ringer's or Plasma-Lyte in the Emergency
      Department (SALT-ED) trial, both published in the New England Journal of Medicine in 2018 and
      led by Vanderbilt investigators. Similarly, a second educational module concerning
      evidence-based pain management and opioid prescribing practices will be distributed via email
      or SMS text messaging.

      Participants will receive one question per day. If the participant does not answer the
      question correctly, they will receive the opportunity to attempt the question again after
      reviewing evidence-based education. All questions have been curated and reviewed by a panel
      of experts and piloted within VUMC for feasibility and acceptability. Key concepts are
      repeated in each module and questions are strategically ordered throughout each module to
      accomplish spaced education.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Median morphine milligram equivalents (MME) per opioid prescription
time frame: 8 months
description: By extracting prescribing data for opioids from the electronic health records
measure: Percentage of orders for balanced intravenous (IV) fluid solutions (i.e. not normal saline)
time frame: 8 months
description: By extracting prescribing data for intravenous fluids from the electronic health records
measure: Chloride levels in patients receiving intravenous fluid orders from a provider enrolled in the study
time frame: 8 months
description: By extracting chloride level data from the electronic health records
measure: Potassium levels in patients receiving intravenous fluid orders from a provider enrolled in the study
time frame: 8 months
description: By extracting potassium level data from the electronic health records
measure: Major Adverse Kidney Events by 30 days (MAKE 30) in patients receiving intravenous fluid orders from a provider enrolled in the study
time frame: 30 days
description: By extracting data from the electronic health records
measure: Length of stay for patients receiving an intravenous fluid order or an opioid prescription from a provider enrolled in the study.
time frame: 8 months
description: By extracting length of stay data from the electronic health records
measure: Length of stay in the intensive care unit (ICU) for patients receiving an intravenous fluid order or an opioid prescription from a provider enrolled in the study
time frame: 8 months
description: By extracting ICU length of stay from the electronic health records
measure: Median number of pills per prescription for patients receiving an opioid prescription from a provider enrolled in the study
time frame: 8 months
description: By extracting medication data from the electronic health records
measure: Percent of opioid prescriptions (inpatient) that also had a scheduled (not pro re nata (PRN)) non-opioid (APAP, nonsteroidal anti-inflammatory drugs (NSAIDs), gamma-Aminobutyric acid (GABA), muscle relaxant, etc.)
time frame: 8 months
description: By extracting medication data from the electronic health records
measure: Percent of opioid prescriptions (discharge) that also had a scheduled (not PRN) non-opioid (APAP, NSAIDs, GABA, muscle relaxant, etc.)
time frame: 8 months
description: By extracting medication data from the electronic health records
measure: Number of Rapid Response Team calls (RRT s) indexed to the number of patients cared for per prescriber (evaluated by level of engagement of the learner with QuizTime)
time frame: 8 months
description: By extracting RRT calls from the electronic health records
arm group label: Opioid module first then fluid
arm group type: Active Comparator
description: The providers in this arm will first receive daily information and questions related to opioid use for eight weeks and then daily information and questions related to intravenous fluid prescribing for five weeks.
arm group label: Fluid module first then opioid
arm group type: Active Comparator
description: The providers in this arm will first receive daily information and questions related to intravenous fluid prescribing for five weeks and then daily information and questions related to opioid use for eight weeks.
intervention type: Behavioral
intervention name: Quiztime modules
description: Text Messaging or Email system
arm group label: Fluid module first then opioid
arm group label: Opioid module first then fluid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew McEvoy, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Matthew McEvoy
investigator title: Professor of Anesthesiology
sharing ipd: Yes
ipd description: Data dictionaries and individual participant data that underlie the results reported after de-identification will be available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: 3 months after publication for 5 years
ipd access criteria: Researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.