<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/NCT03034278</url>
  </required_header>
  <id_info>
    <org_study_id>14-1938</org_study_id>
    <secondary_id>1K23DA040923-01A1</secondary_id>
    <nct_id>NCT03034278</nct_id>
  </id_info>
  <brief_title>Self-reported Usage Patterns of Opioid Analgesic Medications After Surgery</brief_title>
  <official_title>Improving Opioid Prescription Safety After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <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 primary objective of this study is to better understand post-discharge utilization of&#xD;
      prescribed opioid analgesic medications following surgery. A secondary objective of this&#xD;
      study is to gain a better understanding of prevailing modes of storage for opioid&#xD;
      medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      Prescription of medications for analgesia after surgery frequently occurs on an empiric&#xD;
      rather than individualized basis. The investigator will hypothesize that prescribed opioid&#xD;
      medications for analgesia after discharge from the hospital / surgery center are frequently&#xD;
      not taken.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      i) The descriptive first aim of this study is to define self-reported usage patterns of&#xD;
      opioid analgesic medications at home following surgery.&#xD;
&#xD;
      ii) The descriptive second aim of this study is to define prevailing modes of storage and/or&#xD;
      disposal for opioid medications prescribed to patients after hospital discharge following&#xD;
      surgery.&#xD;
&#xD;
      iii) The analytical second aim of this study is to characterize patients who do not take&#xD;
      significant amounts of their prescribed opioid medications.&#xD;
&#xD;
      Background &amp; Exploratory Objective (s):&#xD;
&#xD;
      Accidents (unintentional injuries) were the 5th leading cause of death among the general&#xD;
      population in the United States in 2010. Among persons 1-44 years of age accidents&#xD;
      represented the leading cause of death. And, within this group, pharmaceuticals were the #1&#xD;
      course of death. Of the 22,134 medication associated deaths in 2010, 75.2% included opioid&#xD;
      analgesics. The trajectory of this development is alarming: Deaths from prescription opioid&#xD;
      overdoses have more than tripled in recent years. Of special concern is that children are&#xD;
      especially vulnerable to unintentional medication overdosing, accounting for 71,224 annual&#xD;
      emergency room visits for this reason from 2004-2005 alone. In addition to the individual&#xD;
      burden from morbidity and mortality, the costs of prescription opioid abuse to society are&#xD;
      immense: The average health care costs for patients abusing opioids are 8 times higher than&#xD;
      for non-abusers. In the United States alone, $55.7 billion were spent on sequelae in the&#xD;
      workplace and in healthcare costs. Accordingly, prescription drug overdosing has been coined&#xD;
      &quot;An American Epidemic&quot; and increasing resources to tackle this rapidly growing public health&#xD;
      problem have been made available on a national (National Institutes of Health, U.S. Food and&#xD;
      Drug Administration) and the state level as part of the Colorado Consortium for Prescription&#xD;
      Drug Abuse created through Governor Hickenlooper's efforts with the National Governors&#xD;
      Association.&#xD;
&#xD;
      Additionally, the prescription of opioids following surgery usually occurs using a &quot;one size&#xD;
      fits all approach&quot;, leading potentially to many unused opioids that are then likely to be&#xD;
      utilized in a fashion unintended by prescribing clinician.&#xD;
&#xD;
      The goal of the proposed study is to assess self-reported intake relative to prescribed&#xD;
      amounts of analgesic medications after surgery. Better knowledge of this relationship will&#xD;
      permit the design of tools to individualize analgesic pharmacotherapy after hospital&#xD;
      discharge. The goal is to reduce the amount of opioid prescriptions that are not needed and&#xD;
      to improve non-opioid analgesia.&#xD;
&#xD;
      These data will inform future studies to design more patient-centered opioid prescribing&#xD;
      tools, which are based on anticipated need. This will likely decrease the amounts of&#xD;
      prescribed opioids that are available for non-medical use. Future studies will be aimed to&#xD;
      standardize their use to provide improved analgesia upon discharge following surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ratio of patient-reported intake of oral opioids to prescribed amount of oral opioid medications</measure>
    <time_frame>4 weeks after hospital discharge date.</time_frame>
    <description>A self-report survey will assess opioid medication use in surgical patients during the 4 weeks following hospital discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Storage of opioid medication in surgical patients after hospital discharge</measure>
    <time_frame>4 weeks after hospital discharge date.</time_frame>
    <description>A self-report survey will assess storage of opioid medication in surgical patients up to 4 weeks after discharge from the hospital.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Description of surgical patients from their electronic medical record</measure>
    <time_frame>Date of admission to hospital up to thirty days after hospital discharge date.</time_frame>
    <description>For each surgical patient who completes the study survey we will access their electronic medical record and characterize them by age, gender, race, type of insurance, body mass index, comorbid medical conditions, type of surgical procedure and severity, pre-operative and in-hospital opioid use, and use of acetaminophen and NSAIDs. We will then relate these patient characteristics to the participants responses on the study surveys.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">785</enrollment>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Post surgery patients</arm_group_label>
    <description>Patients prescribed with opioid analgesic medications following surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Not applicable - no intervention</intervention_name>
    <description>Not applicable - no intervention, observational survey study.</description>
    <arm_group_label>Post surgery patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study Design/Methods:&#xD;
&#xD;
        Survey population: Patients ages 18-89 undergoing surgery at the University of Colorado&#xD;
        Hospital are eligible. We will focus on patients after Cesarean section surgery,&#xD;
        gastrointestinal, and thoracic surgery.&#xD;
&#xD;
        Following exclusion of all patients under the age of 18 years, patients who do not&#xD;
        understand Spanish or English, and patients returning to institutional settings (e.g.&#xD;
        prison, jail, mental health facility), pregnant women, and decisionally challenged&#xD;
        patients, the investigators will include all remaining patients in the sample.&#xD;
&#xD;
        The investigators will focus on adult patients after 1) Cesarean section, 2) thoracic&#xD;
        surgery procedures, and 3) gastrointestinal surgery procedures.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult patients undergoing:&#xD;
&#xD;
          -  Cesarean section,&#xD;
&#xD;
          -  Gastrointestinal surgery, or&#xD;
&#xD;
          -  Thoracic surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18 years of age,&#xD;
&#xD;
          -  Patients known or suspected to be pregnant at the time of discharge,&#xD;
&#xD;
          -  Patients that are prisoners,&#xD;
&#xD;
          -  Patients that are decisionally challenged,&#xD;
&#xD;
          -  Patients that are blind, and&#xD;
&#xD;
          -  Patients that are illiterate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karsten Bartels, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</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>Bartels K, Binswanger IA, Hopfer CJ. Sources of Prescription Opioids for Nonmedical Use. J Addict Med. 2016 Mar-Apr;10(2):134. doi: 10.1097/ADM.0000000000000192. No abstract available.</citation>
    <PMID>26985647</PMID>
  </reference>
  <results_reference>
    <citation>Carrico JA, Mahoney K, Raymond KM, McWilliams SK, Mayes LM, Mikulich-Gilbertson SK, Bartels K. Predicting Opioid Use Following Discharge After Cesarean Delivery. Ann Fam Med. 2020 Mar;18(2):118-126. doi: 10.1370/afm.2493.</citation>
    <PMID>32152015</PMID>
  </results_reference>
  <results_reference>
    <citation>Abrams BA, Murray KA, Mahoney K, Raymond KM, McWilliams SK, Nichols S, Mahmoudi E, Mayes LM, Fernandez-Bustamante A, Mitchell JD, Meguid RA, Zanotti G, Bartels K. Postdischarge Pain Management After Thoracic Surgery: A Patient-Centered Approach. Ann Thorac Surg. 2020 Nov;110(5):1714-1721. doi: 10.1016/j.athoracsur.2020.04.048. Epub 2020 Jun 1.</citation>
    <PMID>32497643</PMID>
  </results_reference>
  <results_reference>
    <citation>Bartels K, Mahoney K, Raymond KM, McWilliams SK, Fernandez-Bustamante A, Schulick R, Hopfer CJ, Mikulich-Gilbertson SK. Opioid and non-opioid utilization at home following gastrointestinal procedures: a prospective cohort study. Surg Endosc. 2020 Jan;34(1):304-311. doi: 10.1007/s00464-019-06767-1. Epub 2019 Apr 3.</citation>
    <PMID>30945059</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>September 15, 2021</last_update_submitted>
  <last_update_submitted_qc>September 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>opioid use</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03034278/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03034278
org study id: 14-1938
secondary id: 1K23DA040923-01A1
nct id: NCT03034278
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to better understand post-discharge utilization of
      prescribed opioid analgesic medications following surgery. A secondary objective of this
      study is to gain a better understanding of prevailing modes of storage for opioid
      medications.
Hypothesis:

      Prescription of medications for analgesia after surgery frequently occurs on an empiric
      rather than individualized basis. The investigator will hypothesize that prescribed opioid
      medications for analgesia after discharge from the hospital / surgery center are frequently
      not taken.

      Aims:

      i) The descriptive first aim of this study is to define self-reported usage patterns of
      opioid analgesic medications at home following surgery.

      ii) The descriptive second aim of this study is to define prevailing modes of storage and/or
      disposal for opioid medications prescribed to patients after hospital discharge following
      surgery.

      iii) The analytical second aim of this study is to characterize patients who do not take
      significant amounts of their prescribed opioid medications.

      Background & Exploratory Objective (s):

      Accidents (unintentional injuries) were the 5th leading cause of death among the general
      population in the United States in 2010. Among persons 1-44 years of age accidents
      represented the leading cause of death. And, within this group, pharmaceuticals were the #1
      course of death. Of the 22,134 medication associated deaths in 2010, 75.2% included opioid
      analgesics. The trajectory of this development is alarming: Deaths from prescription opioid
      overdoses have more than tripled in recent years. Of special concern is that children are
      especially vulnerable to unintentional medication overdosing, accounting for 71,224 annual
      emergency room visits for this reason from 2004-2005 alone. In addition to the individual
      burden from morbidity and mortality, the costs of prescription opioid abuse to society are
      immense: The average health care costs for patients abusing opioids are 8 times higher than
      for non-abusers. In the United States alone, $55.7 billion were spent on sequelae in the
      workplace and in healthcare costs. Accordingly, prescription drug overdosing has been coined
      "An American Epidemic" and increasing resources to tackle this rapidly growing public health
      problem have been made available on a national (National Institutes of Health, U.S. Food and
      Drug Administration) and the state level as part of the Colorado Consortium for Prescription
      Drug Abuse created through Governor Hickenlooper's efforts with the National Governors
      Association.

      Additionally, the prescription of opioids following surgery usually occurs using a "one size
      fits all approach", leading potentially to many unused opioids that are then likely to be
      utilized in a fashion unintended by prescribing clinician.

      The goal of the proposed study is to assess self-reported intake relative to prescribed
      amounts of analgesic medications after surgery. Better knowledge of this relationship will
      permit the design of tools to individualize analgesic pharmacotherapy after hospital
      discharge. The goal is to reduce the amount of opioid prescriptions that are not needed and
      to improve non-opioid analgesia.

      These data will inform future studies to design more patient-centered opioid prescribing
      tools, which are based on anticipated need. This will likely decrease the amounts of
      prescribed opioids that are available for non-medical use. Future studies will be aimed to
      standardize their use to provide improved analgesia upon discharge following surgery.
observational model: Cohort
time perspective: Prospective
measure: Ratio of patient-reported intake of oral opioids to prescribed amount of oral opioid medications
time frame: 4 weeks after hospital discharge date.
description: A self-report survey will assess opioid medication use in surgical patients during the 4 weeks following hospital discharge.
measure: Storage of opioid medication in surgical patients after hospital discharge
time frame: 4 weeks after hospital discharge date.
description: A self-report survey will assess storage of opioid medication in surgical patients up to 4 weeks after discharge from the hospital.
measure: Description of surgical patients from their electronic medical record
time frame: Date of admission to hospital up to thirty days after hospital discharge date.
description: For each surgical patient who completes the study survey we will access their electronic medical record and characterize them by age, gender, race, type of insurance, body mass index, comorbid medical conditions, type of surgical procedure and severity, pre-operative and in-hospital opioid use, and use of acetaminophen and NSAIDs. We will then relate these patient characteristics to the participants responses on the study surveys.
arm group label: Post surgery patients
description: Patients prescribed with opioid analgesic medications following surgery.
intervention type: Other
intervention name: Not applicable - no intervention
description: Not applicable - no intervention, observational survey study.
arm group label: Post surgery patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karsten Bartels, MD
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: Bartels K, Binswanger IA, Hopfer CJ. Sources of Prescription Opioids for Nonmedical Use. J Addict Med. 2016 Mar-Apr;10(2):134. doi: 10.1097/ADM.0000000000000192. No abstract available.
PMID: 26985647
citation: Carrico JA, Mahoney K, Raymond KM, McWilliams SK, Mayes LM, Mikulich-Gilbertson SK, Bartels K. Predicting Opioid Use Following Discharge After Cesarean Delivery. Ann Fam Med. 2020 Mar;18(2):118-126. doi: 10.1370/afm.2493.
PMID: 32152015
citation: Abrams BA, Murray KA, Mahoney K, Raymond KM, McWilliams SK, Nichols S, Mahmoudi E, Mayes LM, Fernandez-Bustamante A, Mitchell JD, Meguid RA, Zanotti G, Bartels K. Postdischarge Pain Management After Thoracic Surgery: A Patient-Centered Approach. Ann Thorac Surg. 2020 Nov;110(5):1714-1721. doi: 10.1016/j.athoracsur.2020.04.048. Epub 2020 Jun 1.
PMID: 32497643
citation: Bartels K, Mahoney K, Raymond KM, McWilliams SK, Fernandez-Bustamante A, Schulick R, Hopfer CJ, Mikulich-Gilbertson SK. Opioid and non-opioid utilization at home following gastrointestinal procedures: a prospective cohort study. Surg Endosc. 2020 Jan;34(1):304-311. doi: 10.1007/s00464-019-06767-1. Epub 2019 Apr 3.
PMID: 30945059
responsible party type: Sponsor
sharing ipd: No
provided document: 