<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/NCT04446975</url>
  </required_header>
  <id_info>
    <org_study_id>19-3095</org_study_id>
    <nct_id>NCT04446975</nct_id>
  </id_info>
  <brief_title>Best Practice Alert for Opioid Prescribing</brief_title>
  <official_title>Best Practice Alert for Post-Surgical Opioid Prescribing At Discharge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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 investigators will embed a developed decision support tool into the electronic health&#xD;
      record (EHR) to individualize pain therapy in surgical patients after hospital discharge and&#xD;
      test its performance in a pragmatic clinical trial.&#xD;
&#xD;
      Preliminary data indicate that current opioid prescription practice after surgery follows a&#xD;
      &quot;one size fits all&quot; pattern. In-hospital opioid use prior to discharge serves as a reliable&#xD;
      indicator to estimate needs for analgesic medications at home. The investigators will test&#xD;
      the hypothesis that the existing tool will enable providers to write need-based prescriptions&#xD;
      based on prior-to-discharge opioid use, empower patients to maximize alternatives to opioids&#xD;
      (ALTO) therapies at home, while minimizing the need for rescue prescriptions. The&#xD;
      investigators will test this tool prospectively in a cohort of ~1,000 providers (primary&#xD;
      subjects) and ~39,000 surgical patients (secondary subjects) in four University of Colorado&#xD;
      Health (UCHealth) hospitals (clusters to be exposed versus (vs.) non-exposed to the&#xD;
      intervention).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Converting knowledge on actual need for opioid pain medications after surgery into tangible&#xD;
      benefits can prevent over-prescription of opioids that become available for non-medical use.&#xD;
      The objective of this aim is to prescribe pain medications after surgery in a&#xD;
      patient-centered fashion. The investigators have used the average amount of opioid&#xD;
      medications (in milligram morphine equivalents - MME) taken prior to discharge to inform the&#xD;
      clinical decision support tool. This tool will reduce the amount of opioid medications&#xD;
      prescribed while maintaining patient post-operative pain control. The calculated &quot;prior to&#xD;
      discharge daily MME dose&quot; will be applied to generate a recommendation for the prescription&#xD;
      of a cumulative opioid dose that will be displayed when the electronic order entry for the&#xD;
      post-discharge pain medication is made in the EHR using a best-practice alert (BPA). In&#xD;
      addition, the provider will be prompted to also prescribe non-opioid analgesic medications.&#xD;
      This BPA was developed by the Principal Investigator under guidance of the UCHealth System&#xD;
      Multidisciplinary Opioid/Pain Management Committee as well as published guidelines.&#xD;
&#xD;
      Based on the relationship between opioids taken prior to discharge and post-discharge opioid&#xD;
      intake described above as well as published guidelines for post-discharge prescriptions after&#xD;
      surgery will use a tiered approach towards determining the total amount of opioids to be&#xD;
      prescribed. Accordingly, the investigators have integrated an algorithm into the BPA such&#xD;
      that opioid intake from the EHR only triggers the BPA if the total amount of prescribed&#xD;
      opioids exceeds the predicted thresholds.&#xD;
&#xD;
      The opioid prescribing BPA will be assessed over a 44-week period in all eligible patients.&#xD;
      At the time of writing the prescription an automatic notification will appear on the care&#xD;
      provider's screen that identifies a suggested post-discharge opioid dose within the&#xD;
      electronic prescription pad. If approved by the provider, opioid-only prescriptions will be&#xD;
      written as suggested. Final dosing decisions and drug choices will remain at the discretion&#xD;
      of the treating provider and will be tracked. The investigators will use an all &quot;ON&quot; vs. all&#xD;
      &quot;OFF&quot; configuration to answer the questions if the average amount of total opioids per&#xD;
      post-discharge prescription is lower with the BPA active. The investigation will commence&#xD;
      with two &quot;OFF&quot; periods to assess if reduction in prescribing patterns occurs over time&#xD;
      regardless of the intervention. Two &quot;ON&quot; periods at the end of the study will determine if&#xD;
      any observed changes in prescribing patterns stabilize or continued changes take place.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Sequential Assignment</intervention_model>
    <intervention_model_description>This trial will be designed using a stepped wedge design with randomization occurring based on timing and location of enrollment according to PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary) to maximize applicability. The BPA will be turned &quot;OFF&quot; vs. &quot;ON&quot; in the participating hospitals according to each 8-week study interval. OFF and ON periods will be separated by 4-week washout intervals. An 8-week period prior to study start will provide baseline trends in prescription patterns. The investigation will commence with two &quot;OFF&quot; periods to assess if reduction in prescribing patterns occurs over time regardless of the intervention. Two &quot;ON&quot; periods at the end of the study will determine if any observed changes in prescribing patterns stabilize or continued changes take place.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioids prescribed at discharge</measure>
    <time_frame>1 day, on discharge date from hospital</time_frame>
    <description>Prescribed mean milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-opioid pain medications prescribed on day of discharge</measure>
    <time_frame>1 day, on discharge date from hospital</time_frame>
    <description>Prescribed discharge non-opioid analgesic medications as recorded in the electronic health record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid prescriptions after discharge</measure>
    <time_frame>&quot;Day of discharge +1&quot; until 28 days after discharge</time_frame>
    <description>Number of opioid scripts and total milligram morphine equivalents (MME) as recorded in the electronic health record</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40000</enrollment>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>BPA Off</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No BPA message is displayed to providers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BPA On</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BPA message is displayed to providers based on patient opioid intake as reported in the EHR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BPA</intervention_name>
    <description>At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.</description>
    <arm_group_label>BPA On</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Primary subjects:&#xD;
&#xD;
        • Credentialed providers (attending, fellow, and resident physicians, advanced practice&#xD;
        providers including nurse practitioners and physician assistants) at each UCH (UC Health)&#xD;
        site writing a discharge opioid prescription are eligible to receive the intervention.&#xD;
&#xD;
        Secondary subjects:&#xD;
&#xD;
        • Adult surgical inpatients age 18 and older within the UCHealth system at 4 different&#xD;
        hospitals including UCH Metro, UCH Memorial Central, Medical Center of the Rockies, and&#xD;
        Poudre Valley Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Primary subjects:&#xD;
&#xD;
        • None&#xD;
&#xD;
        Secondary subjects:&#xD;
&#xD;
        • Less than 18 years of age.&#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>Karsten Bartels, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.</citation>
    <PMID>26824844</PMID>
  </reference>
  <reference>
    <citation>Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.</citation>
    <PMID>25956159</PMID>
  </reference>
  <reference>
    <citation>Bartels K, Fernandez-Bustamante A, McWilliams SK, Hopfer CJ, Mikulich-Gilbertson SK. Long-term opioid use after inpatient surgery - A retrospective cohort study. Drug Alcohol Depend. 2018 Jun 1;187:61-65. doi: 10.1016/j.drugalcdep.2018.02.013. Epub 2018 Mar 27.</citation>
    <PMID>29627407</PMID>
  </reference>
  <reference>
    <citation>Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.</citation>
    <PMID>29238810</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 6, 2023</submitted>
    <returned>March 6, 2023</returned>
    <submitted>March 8, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04446975
org study id: 19-3095
nct id: NCT04446975
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will embed a developed decision support tool into the electronic health
      record (EHR) to individualize pain therapy in surgical patients after hospital discharge and
      test its performance in a pragmatic clinical trial.

      Preliminary data indicate that current opioid prescription practice after surgery follows a
      "one size fits all" pattern. In-hospital opioid use prior to discharge serves as a reliable
      indicator to estimate needs for analgesic medications at home. The investigators will test
      the hypothesis that the existing tool will enable providers to write need-based prescriptions
      based on prior-to-discharge opioid use, empower patients to maximize alternatives to opioids
      (ALTO) therapies at home, while minimizing the need for rescue prescriptions. The
      investigators will test this tool prospectively in a cohort of ~1,000 providers (primary
      subjects) and ~39,000 surgical patients (secondary subjects) in four University of Colorado
      Health (UCHealth) hospitals (clusters to be exposed versus (vs.) non-exposed to the
      intervention).
Converting knowledge on actual need for opioid pain medications after surgery into tangible
      benefits can prevent over-prescription of opioids that become available for non-medical use.
      The objective of this aim is to prescribe pain medications after surgery in a
      patient-centered fashion. The investigators have used the average amount of opioid
      medications (in milligram morphine equivalents - MME) taken prior to discharge to inform the
      clinical decision support tool. This tool will reduce the amount of opioid medications
      prescribed while maintaining patient post-operative pain control. The calculated "prior to
      discharge daily MME dose" will be applied to generate a recommendation for the prescription
      of a cumulative opioid dose that will be displayed when the electronic order entry for the
      post-discharge pain medication is made in the EHR using a best-practice alert (BPA). In
      addition, the provider will be prompted to also prescribe non-opioid analgesic medications.
      This BPA was developed by the Principal Investigator under guidance of the UCHealth System
      Multidisciplinary Opioid/Pain Management Committee as well as published guidelines.

      Based on the relationship between opioids taken prior to discharge and post-discharge opioid
      intake described above as well as published guidelines for post-discharge prescriptions after
      surgery will use a tiered approach towards determining the total amount of opioids to be
      prescribed. Accordingly, the investigators have integrated an algorithm into the BPA such
      that opioid intake from the EHR only triggers the BPA if the total amount of prescribed
      opioids exceeds the predicted thresholds.

      The opioid prescribing BPA will be assessed over a 44-week period in all eligible patients.
      At the time of writing the prescription an automatic notification will appear on the care
      provider's screen that identifies a suggested post-discharge opioid dose within the
      electronic prescription pad. If approved by the provider, opioid-only prescriptions will be
      written as suggested. Final dosing decisions and drug choices will remain at the discretion
      of the treating provider and will be tracked. The investigators will use an all "ON" vs. all
      "OFF" configuration to answer the questions if the average amount of total opioids per
      post-discharge prescription is lower with the BPA active. The investigation will commence
      with two "OFF" periods to assess if reduction in prescribing patterns occurs over time
      regardless of the intervention. Two "ON" periods at the end of the study will determine if
      any observed changes in prescribing patterns stabilize or continued changes take place.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: This trial will be designed using a stepped wedge design with randomization occurring based on timing and location of enrollment according to PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary) to maximize applicability. The BPA will be turned "OFF" vs. "ON" in the participating hospitals according to each 8-week study interval. OFF and ON periods will be separated by 4-week washout intervals. An 8-week period prior to study start will provide baseline trends in prescription patterns. The investigation will commence with two "OFF" periods to assess if reduction in prescribing patterns occurs over time regardless of the intervention. Two "ON" periods at the end of the study will determine if any observed changes in prescribing patterns stabilize or continued changes take place.
primary purpose: Other
masking: Single (Participant)
measure: Opioids prescribed at discharge
time frame: 1 day, on discharge date from hospital
description: Prescribed mean milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record
measure: Non-opioid pain medications prescribed on day of discharge
time frame: 1 day, on discharge date from hospital
description: Prescribed discharge non-opioid analgesic medications as recorded in the electronic health record
measure: Opioid prescriptions after discharge
time frame: "Day of discharge +1" until 28 days after discharge
description: Number of opioid scripts and total milligram morphine equivalents (MME) as recorded in the electronic health record
arm group label: BPA Off
arm group type: No Intervention
description: No BPA message is displayed to providers.
arm group label: BPA On
arm group type: Experimental
description: BPA message is displayed to providers based on patient opioid intake as reported in the EHR.
intervention type: Other
intervention name: BPA
description: At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.
arm group label: BPA On
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karsten Bartels, MD, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
citation: Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
PMID: 26824844
citation: Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
PMID: 25956159
citation: Bartels K, Fernandez-Bustamante A, McWilliams SK, Hopfer CJ, Mikulich-Gilbertson SK. Long-term opioid use after inpatient surgery - A retrospective cohort study. Drug Alcohol Depend. 2018 Jun 1;187:61-65. doi: 10.1016/j.drugalcdep.2018.02.013. Epub 2018 Mar 27.
PMID: 29627407
citation: Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.
PMID: 29238810
responsible party type: Sponsor
sharing ipd: No
submitted: January 6, 2023
returned: March 6, 2023
submitted: March 8, 2023