<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/NCT03030469</url>
  </required_header>
  <id_info>
    <org_study_id>2016-7373</org_study_id>
    <nct_id>NCT03030469</nct_id>
  </id_info>
  <brief_title>Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices</brief_title>
  <official_title>A Cluster-randomized Trial of Modifying Electronic Health Record Defaults to Reduce the Prescribed Quantity of Opioid Analgesics in Dentistry Practices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is to investigate the impact of changing opioid analgesic&#xD;
      prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult&#xD;
      dentistry settings. We will change prescribing defaults for select short-acting opioid&#xD;
      analgesics including immediate release oxycodone and hydrocodone as well as codeine and&#xD;
      tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial&#xD;
      of three Montefiore Medical Center dentistry sites, we will evaluate the impact of this&#xD;
      intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and&#xD;
      12 months post-intervention).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">July 13, 2018</completion_date>
  <primary_completion_date type="Actual">July 13, 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Initial prescription number of pills to dispense</measure>
    <time_frame>Through study completion (18 months)</time_frame>
    <description>From the electronic health record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Initial prescription morphine milligram equivalents to dispense</measure>
    <time_frame>Through study completion (18 months)</time_frame>
    <description>From the electronic health record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid analgesic reorder (y/n)</measure>
    <time_frame>Within 30 days after the initial prescription</time_frame>
    <description>From the electronic health record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total opioid analgesic pills to dispense, including re-orders</measure>
    <time_frame>Within 30 days after the initial prescription</time_frame>
    <description>From the electronic health record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total morphine milligram equivalents to dispense, including re-orders</measure>
    <time_frame>Within 30 days after the initial prescription</time_frame>
    <description>From the electronic health record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outpatient visits</measure>
    <time_frame>Within 30 days after the index prescription</time_frame>
    <description>From the electronic health record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department visits</measure>
    <time_frame>Within 30 days after the initial prescription</time_frame>
    <description>From the electronic health record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>Within 30 days after the initial prescription</time_frame>
    <description>From the electronic health record</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>10-pill default</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention condition consists of a change to the electronic health record so that new opioid analgesic prescriptions automatically default to 10 pills (i.e., the &quot;quantity dispensed&quot; field is pre-populated). This value is modifiable by providers who can tailor the prescription based on clinical factors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5-pill default</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>New opioid analgesic prescriptions will automatically default to 5 pills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control condition will be the usual electronic health record interface. The default number of pills varies by medication, most medications currently have either a blank default or a default of 30 pills.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Change in electronic health record default for new opioid analgesic prescriptions</intervention_name>
    <arm_group_label>10-pill default</arm_group_label>
    <arm_group_label>5-pill default</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Clinical Site Inclusion Criteria:&#xD;
&#xD;
          -  Dentistry clinic within Montefiore Medical Center&#xD;
&#xD;
        Patient Inclusion Criteria:&#xD;
&#xD;
          -  Received a new opioid analgesic prescription, defined as no opioid analgesic&#xD;
             prescription in the preceding 6 months&#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>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcus Bachhuber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>August 13, 2018</last_update_submitted>
  <last_update_submitted_qc>August 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Marcus Bachhuber</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
    <mesh_term>Analgesics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03030469
org study id: 2016-7373
nct id: NCT03030469
lead sponsor: 
collaborator: 
has dmc: No
The goal of this research is to investigate the impact of changing opioid analgesic
      prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult
      dentistry settings. We will change prescribing defaults for select short-acting opioid
      analgesics including immediate release oxycodone and hydrocodone as well as codeine and
      tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial
      of three Montefiore Medical Center dentistry sites, we will evaluate the impact of this
      intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and
      12 months post-intervention).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Initial prescription number of pills to dispense
time frame: Through study completion (18 months)
description: From the electronic health record
measure: Initial prescription morphine milligram equivalents to dispense
time frame: Through study completion (18 months)
description: From the electronic health record
measure: Opioid analgesic reorder (y/n)
time frame: Within 30 days after the initial prescription
description: From the electronic health record
measure: Total opioid analgesic pills to dispense, including re-orders
time frame: Within 30 days after the initial prescription
description: From the electronic health record
measure: Total morphine milligram equivalents to dispense, including re-orders
time frame: Within 30 days after the initial prescription
description: From the electronic health record
measure: Outpatient visits
time frame: Within 30 days after the index prescription
description: From the electronic health record
measure: Emergency department visits
time frame: Within 30 days after the initial prescription
description: From the electronic health record
measure: Hospitalizations
time frame: Within 30 days after the initial prescription
description: From the electronic health record
arm group label: 10-pill default
arm group type: Experimental
description: The intervention condition consists of a change to the electronic health record so that new opioid analgesic prescriptions automatically default to 10 pills (i.e., the "quantity dispensed" field is pre-populated). This value is modifiable by providers who can tailor the prescription based on clinical factors.
arm group label: 5-pill default
arm group type: Experimental
description: New opioid analgesic prescriptions will automatically default to 5 pills.
arm group label: Standard of care
arm group type: No Intervention
description: The control condition will be the usual electronic health record interface. The default number of pills varies by medication, most medications currently have either a blank default or a default of 30 pills.
intervention type: Other
intervention name: Change in electronic health record default for new opioid analgesic prescriptions
arm group label: 10-pill default
arm group label: 5-pill default
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcus Bachhuber, MD
role: Principal Investigator
affiliation: Montefiore Medical Center
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Marcus Bachhuber
investigator title: Assistant Professor
mesh term: Acute Pain
mesh term: Analgesics, Opioid
mesh term: Analgesics
sharing ipd: Undecided