<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/NCT02244099</url>
  </required_header>
  <id_info>
    <org_study_id>2014H0102</org_study_id>
    <nct_id>NCT02244099</nct_id>
  </id_info>
  <brief_title>Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic</brief_title>
  <official_title>Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to characterize and improve controlled substance, carisoprodol&#xD;
      and tramadol use in an internal medicine residents' clinic. Specific objectives of this study&#xD;
      include:&#xD;
&#xD;
        -  To measure the adherence to a controlled substance treatment agreement (CSTA) before and&#xD;
           after implementation of a population management intervention&#xD;
&#xD;
        -  To determine the number of patients on a CSTA with a discrepancy identified on a urine&#xD;
           drug screen or an Ohio Automated Rx Reporting System (OARRS) report&#xD;
&#xD;
        -  To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day&#xD;
           before and after implementation of a review intervention&#xD;
&#xD;
        -  To characterize the healthcare utilization of patients taking controlled substances,&#xD;
           carisoprodol, or tramadol by tracking the mean number of ED visits, hospital admissions,&#xD;
           telephone calls, and clinic office visits during a 6 month period&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reporting workbench will be used to generate a report from the EMR of all patients of&#xD;
      consenting physicians prescribed a controlled substance, carisoprodol, or tramadol at least 3&#xD;
      times in the past 6 months. This report will also include demographics, number of ED visits&#xD;
      in the last 6 months, hospital admissions in the last 6 months, the number of telephone calls&#xD;
      documented in the last 6 months, the number of clinic visits in the last 6 months, the number&#xD;
      of missed clinic visits in the last 6 months, controlled substance prescribed, directions for&#xD;
      use, number of tabs of medication prescribed, number of refills given, order date and date of&#xD;
      completion of urine drug screen if in last 6 months, if chronic pain is listed as a medical&#xD;
      problem, and if controlled substance treatment agreement has been signed and scanned into&#xD;
      EMR. For each patient of the consenting physicians, the EMR will be reviewed to track next&#xD;
      clinic visit date, urine toxicology screen results, and if there is documentation of an Ohio&#xD;
      Automated Rx Reporting System (OARRS) review. The MED for each patient will be obtained from&#xD;
      the OARRS report and included on the data collection form. For any patients taking opioid&#xD;
      substances at MED ≥ 80 mg/day a review of the appropriateness of this medication and dose&#xD;
      based on EMR documentation will be conducted by clinic physicians and/or pharmacists. This&#xD;
      will all be done in order to make recommendations to the resident physician based on our best&#xD;
      practice recommended controlled substance agreement.&#xD;
&#xD;
      For all patients of the consenting physicians who have an upcoming office visit scheduled,&#xD;
      any recommendations for improved adherence to the CSTA or change in controlled substance,&#xD;
      carisoprodol, or tramadol prescribing based on EMR review findings will be given to the&#xD;
      patient's physician prior to the office visit. Because this intervention is a quality&#xD;
      improvement intervention and studies physician decision making but no direct interaction with&#xD;
      the patient, the patient will not know this study is occurring. An EMR review after the&#xD;
      patient's visit will be completed to track the acceptance of these recommendations leading to&#xD;
      changes in the parameters listed in the data analysis section. Additionally, a second report&#xD;
      will be generated from the reporting workbence 6 months after implementation of this workflow&#xD;
      which includes all patients of the consenting physicians prescribed controlled substances,&#xD;
      tramadol, and carisoprodol (including those on the initial report and those who are now new&#xD;
      patients controlled substances since the time the report was generated) to characterize the&#xD;
      improvement in these parameters for patients in clinic as a whole to track the improvement in&#xD;
      adherence to a controlled substance treatment agreement. See study procedures in Figure 1.&#xD;
      Data Collection will start on 8/1/14 and continue until 12/31/15.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients Adhering to Controlled Substance Agreement</measure>
    <time_frame>18 months</time_frame>
    <description>To measure the adherence to a controlled substance treatment agreement (CSTA) before and after implementation of a population management intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Discrepancy on urine drug screen</measure>
    <time_frame>18 months</time_frame>
    <description>To determine the number of patients on a CSTA with a discrepancy identified on a urine drug screen or an Ohio Automated Rx Reporting System (OARRS) report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine Equivalent Review</measure>
    <time_frame>18 months</time_frame>
    <description>To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day before and after implementation of a review intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>18 months</time_frame>
    <description>To characterize the healthcare utilization of patients taking controlled substances, carisoprodol, or tramadol by tracking the mean number of ED visits, hospital admissions, telephone calls, and clinic office visits during a 6 month period</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Anxiety</condition>
  <condition>Chronic Pain</condition>
  <condition>Opioid Use, Unspecified</condition>
  <arm_group>
    <arm_group_label>Controlled Substance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consenting physicians who care for patients who have been prescribed a controlled substance, carisoprodol, or tramadol at least 3 times in the last 6 months in Martha Morehouse General Internal Medicine Resident Continuity Clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Controlled Substance</intervention_name>
    <description>Patients will be identified using the reporting workbench in the EMR if they have been prescribed a controlled substance, carisoprodol, or tramadol at least 3 times in the last 6 months by one of the consenting resident physicians from Martha Morehouse General Internal Medicine Resident Continuity Clinic. Once identified, a comprehensive chart review for other important parameters based on best practice recommendations as described in the research protocol will be conducted in order to characterize the patient population for which the recommendations are being made to the physicians. Improvement in controlled substance, carisoprodol, and tramadol prescribing and adherence to the CSTA by the resident physicians will be tracked using a pre/post intervention comparison.</description>
    <arm_group_label>Controlled Substance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Residents and attending physicians who work in the resident continuity practice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years of age&#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>Kelli D Barnes, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Jared Moore</investigator_full_name>
    <investigator_title>Assistant Professor - Clinical</investigator_title>
  </responsible_party>
  <keyword>Controlled substance prescribing</keyword>
  <keyword>Controlled substance treatment agreements</keyword>
  <keyword>Opioid use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT02244099
org study id: 2014H0102
nct id: NCT02244099
lead sponsor: 
has dmc: No
The purpose of this study is to characterize and improve controlled substance, carisoprodol
      and tramadol use in an internal medicine residents' clinic. Specific objectives of this study
      include:

        -  To measure the adherence to a controlled substance treatment agreement (CSTA) before and
           after implementation of a population management intervention

        -  To determine the number of patients on a CSTA with a discrepancy identified on a urine
           drug screen or an Ohio Automated Rx Reporting System (OARRS) report

        -  To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day
           before and after implementation of a review intervention

        -  To characterize the healthcare utilization of patients taking controlled substances,
           carisoprodol, or tramadol by tracking the mean number of ED visits, hospital admissions,
           telephone calls, and clinic office visits during a 6 month period
Reporting workbench will be used to generate a report from the EMR of all patients of
      consenting physicians prescribed a controlled substance, carisoprodol, or tramadol at least 3
      times in the past 6 months. This report will also include demographics, number of ED visits
      in the last 6 months, hospital admissions in the last 6 months, the number of telephone calls
      documented in the last 6 months, the number of clinic visits in the last 6 months, the number
      of missed clinic visits in the last 6 months, controlled substance prescribed, directions for
      use, number of tabs of medication prescribed, number of refills given, order date and date of
      completion of urine drug screen if in last 6 months, if chronic pain is listed as a medical
      problem, and if controlled substance treatment agreement has been signed and scanned into
      EMR. For each patient of the consenting physicians, the EMR will be reviewed to track next
      clinic visit date, urine toxicology screen results, and if there is documentation of an Ohio
      Automated Rx Reporting System (OARRS) review. The MED for each patient will be obtained from
      the OARRS report and included on the data collection form. For any patients taking opioid
      substances at MED ≥ 80 mg/day a review of the appropriateness of this medication and dose
      based on EMR documentation will be conducted by clinic physicians and/or pharmacists. This
      will all be done in order to make recommendations to the resident physician based on our best
      practice recommended controlled substance agreement.

      For all patients of the consenting physicians who have an upcoming office visit scheduled,
      any recommendations for improved adherence to the CSTA or change in controlled substance,
      carisoprodol, or tramadol prescribing based on EMR review findings will be given to the
      patient's physician prior to the office visit. Because this intervention is a quality
      improvement intervention and studies physician decision making but no direct interaction with
      the patient, the patient will not know this study is occurring. An EMR review after the
      patient's visit will be completed to track the acceptance of these recommendations leading to
      changes in the parameters listed in the data analysis section. Additionally, a second report
      will be generated from the reporting workbence 6 months after implementation of this workflow
      which includes all patients of the consenting physicians prescribed controlled substances,
      tramadol, and carisoprodol (including those on the initial report and those who are now new
      patients controlled substances since the time the report was generated) to characterize the
      improvement in these parameters for patients in clinic as a whole to track the improvement in
      adherence to a controlled substance treatment agreement. See study procedures in Figure 1.
      Data Collection will start on 8/1/14 and continue until 12/31/15.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Percentage of Patients Adhering to Controlled Substance Agreement
time frame: 18 months
description: To measure the adherence to a controlled substance treatment agreement (CSTA) before and after implementation of a population management intervention
measure: Discrepancy on urine drug screen
time frame: 18 months
description: To determine the number of patients on a CSTA with a discrepancy identified on a urine drug screen or an Ohio Automated Rx Reporting System (OARRS) report
measure: Morphine Equivalent Review
time frame: 18 months
description: To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day before and after implementation of a review intervention
measure: Healthcare Utilization
time frame: 18 months
description: To characterize the healthcare utilization of patients taking controlled substances, carisoprodol, or tramadol by tracking the mean number of ED visits, hospital admissions, telephone calls, and clinic office visits during a 6 month period
arm group label: Controlled Substance
arm group type: Experimental
description: Consenting physicians who care for patients who have been prescribed a controlled substance, carisoprodol, or tramadol at least 3 times in the last 6 months in Martha Morehouse General Internal Medicine Resident Continuity Clinic.
intervention type: Other
intervention name: Controlled Substance
description: Patients will be identified using the reporting workbench in the EMR if they have been prescribed a controlled substance, carisoprodol, or tramadol at least 3 times in the last 6 months by one of the consenting resident physicians from Martha Morehouse General Internal Medicine Resident Continuity Clinic. Once identified, a comprehensive chart review for other important parameters based on best practice recommendations as described in the research protocol will be conducted in order to characterize the patient population for which the recommendations are being made to the physicians. Improvement in controlled substance, carisoprodol, and tramadol prescribing and adherence to the CSTA by the resident physicians will be tracked using a pre/post intervention comparison.
arm group label: Controlled Substance
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kelli D Barnes, PharmD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Jared Moore
investigator title: Assistant Professor - Clinical
mesh term: Chronic Pain