<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/NCT03809507</url>
  </required_header>
  <id_info>
    <org_study_id>18-2495</org_study_id>
    <nct_id>NCT03809507</nct_id>
  </id_info>
  <brief_title>A Strategy to Reduce Opioid Drug Prescribing by Clinicians</brief_title>
  <official_title>A Strategy to Reduce Opioid Drug Prescribing by Clinicians: Survey of Clinicians Analgesic Drug Prescribing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Carolina Department of Health and Human Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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>
      Under the auspices of the Oral Health Section of the NC Department of Health and Human&#xD;
      Services clinician-investigators from the UNC Oral and Maxillofacial Surgery Department are&#xD;
      conducting a survey to assess current analgesic prescribing practices in NC with a goal of&#xD;
      eventually reaching consensus among clinicians for a wide range of procedures and conditions&#xD;
      where pain control is important for successful patient outcomes. We hope that about 850&#xD;
      dentists and 600 physicians will agree to take part in this research study. Participation in&#xD;
      this Qualtrics survey e-mailed in mid-February 2019 will take about 15 minutes or less.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      METHODS&#xD;
&#xD;
      Participants:&#xD;
&#xD;
      Dentists, emergency room physicians and primary care physicians who are in active practice&#xD;
      will be surveyed using the lists of active practitioners with Drug Enforcement&#xD;
      Administration(DEA) licenses provided by the NC Department of Public Health.&#xD;
&#xD;
      Inclusion criteria for dentists: Active dentist with DEA license including: endodontists,&#xD;
      general practice dentists, oral and maxillofacial surgeons, and periodontists.&#xD;
&#xD;
      Given the small numbers per specialty, all endodontists (n=128), periodontists(n=114), and&#xD;
      oral and maxillofacial surgeons (n=178) will be surveyed. A stratified random sample (n =&#xD;
      400) of general dentists (n=3905) will be selected from the list using region of the state as&#xD;
      the stratification factor.&#xD;
&#xD;
      Inclusion criteria for emergency room clinical staff: MD/DO/PA with a primary area of&#xD;
      practice as emergency medicine or urgent care and area(s) of practice as emergency medicine,&#xD;
      urgent care, family medicine, or adolescent &amp; young adult medicine All DO (n = 191) will be&#xD;
      surveyed. A stratified random sample (n= 400) of MD's (N = 1407) and PA's will be selected&#xD;
      from the list using region of the state as the stratification factor.&#xD;
&#xD;
      Qualtrics Survey:&#xD;
&#xD;
      The survey will be divided into two general areas: 1) personal and practice demographics&#xD;
      (sex, age, time in practice (years), practice size) and 2) clinical scenarios typical of&#xD;
      patients seen by the respective practitioners who might be expected to experience acute pain.&#xD;
      For each of the scenarios, practitioners will be asked the type(s) of medication that would&#xD;
      be prescribed, the strength in mg, and the number of doses for each medication.&#xD;
&#xD;
      The survey will be pre-tested by a sample of potential survey subjects who will be asked to&#xD;
      provide open-ended comments regarding ease of completion, confusing items, and word changes.&#xD;
      The survey methods of Salant and Dillman will be used as a guide.(8)&#xD;
&#xD;
      A Qualtics linkage file will be created accessible only to the project investigators. The&#xD;
      linkage file will only be used to identify non-respondents for follow-up. Surveys will be&#xD;
      coded to maintain respondents' confidentiality. Linkage file will be in a pass word protected&#xD;
      file separate from survey responses.&#xD;
&#xD;
      Distribution:&#xD;
&#xD;
      A mixed mode of distribution of the surveys will be used. Qualtrics software (Qualtrics,&#xD;
      Provo, UT) will be used to create electronic versions of the survey to be sent to providers&#xD;
      via email with an accompanying letter describing the purpose of the project and how&#xD;
      confidentiality will be maintained. Teleform (Cardiff Software, Vista, CA) will be used as a&#xD;
      paper alternative for providers who do not wish to respond to the electronic version. For&#xD;
      these individuals a cover letter will be included describing the study along with a postage&#xD;
      paid return envelope. Up to three attempts will be made at two-week intervals, depending on&#xD;
      response versus non-response, to optimize subject participation.(8) The mode for the third&#xD;
      round will be determined by the response rate from each of the first two rounds.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      All survey responses will be de-identified to maintain provider confidentiality. The&#xD;
      electronic and Teleform responses will be merged and analyzed using SAS (version 9.4, Cary,&#xD;
      NC). Respondents will be excluded from data analysis if they do not complete the data for the&#xD;
      prescribing practices.The primary outcome variable will be the clinicians prescribing opioid&#xD;
      drugs for each survey scenario or not. Secondary analyses will explore possible explanatory&#xD;
      variables for the primary outcome. Bivariate analysis will be done by status (degree and&#xD;
      practice mode) to explore the effect of the explanatory variables (age; gender; time in&#xD;
      practice; practice location; and practice size) on the preferred medication option for each&#xD;
      clinical scenario. Comparisons among degree/specialty holders is not possible given that the&#xD;
      scenarios presented are unique to the different groups. The use of Chi-square or Fisher's&#xD;
      Exact test for the bivariate analysis will be determined based on the cell frequencies. Level&#xD;
      of significance was set at 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2019</start_date>
  <completion_date type="Actual">August 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>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Clinicians Prescribing Opioid Drugs for each Survey Scenario</measure>
    <time_frame>one year</time_frame>
    <description>Qualtrics Survey of NC Clinicians with DEA registration. Yes/No responses for opioid drug prescribing for 2 to 3 scenarios differing by target group of clinicians will be asked of 6 different clinician types, emergency room physicians, general dentists and dental specialists..</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">895</enrollment>
  <condition>Analgesics Opioid</condition>
  <arm_group>
    <arm_group_label>NC Clinicians</arm_group_label>
    <description>Qualtrics Survey of NC Clinicians with DEA registration</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qualtrics survey questions</intervention_name>
    <description>Qualtrics Survey:&#xD;
For each of the scenarios, practitioners will be asked whether opioids are prescribed or not, and the type(s) of other analgesic medications that would be prescribed, the strength in mg, and the number of doses for each medication</description>
    <arm_group_label>NC Clinicians</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        General dentists, Endodontists, Periodontists, Oral and Maxillofacial Surgeons. Emergency&#xD;
        Room Physicians&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NC licensed dentists or physicians with active DEA registration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NC licensed dentists or physicians with no active DEA registration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond P White, Jr, DDS. PhD</last_name>
    <role>Study Director</role>
    <affiliation>Oral and Maxillofacial Surgery, UNC School of Dentistry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Glenn Reside, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oral and Maxillofacial Surgery, UNC School of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina School of Dentistry</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>opioids</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified data that supports results will be shared provided the investigator who proposes use of the data has Institutional Review Board(IRB), Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with UNC</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>beginning 9 to 36 months following publication</ipd_time_frame>
    <ipd_access_criteria>Institutional Review Board(IRB), Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with UNC</ipd_access_criteria>
    <ipd_url>https://research.unc.edu/clinical-trials/clinical-trials-gov/data-sharing-guidance/).</ipd_url>
  </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/NCT03809507
org study id: 18-2495
nct id: NCT03809507
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Under the auspices of the Oral Health Section of the NC Department of Health and Human
      Services clinician-investigators from the UNC Oral and Maxillofacial Surgery Department are
      conducting a survey to assess current analgesic prescribing practices in NC with a goal of
      eventually reaching consensus among clinicians for a wide range of procedures and conditions
      where pain control is important for successful patient outcomes. We hope that about 850
      dentists and 600 physicians will agree to take part in this research study. Participation in
      this Qualtrics survey e-mailed in mid-February 2019 will take about 15 minutes or less.
METHODS

      Participants:

      Dentists, emergency room physicians and primary care physicians who are in active practice
      will be surveyed using the lists of active practitioners with Drug Enforcement
      Administration(DEA) licenses provided by the NC Department of Public Health.

      Inclusion criteria for dentists: Active dentist with DEA license including: endodontists,
      general practice dentists, oral and maxillofacial surgeons, and periodontists.

      Given the small numbers per specialty, all endodontists (n=128), periodontists(n=114), and
      oral and maxillofacial surgeons (n=178) will be surveyed. A stratified random sample (n =
      400) of general dentists (n=3905) will be selected from the list using region of the state as
      the stratification factor.

      Inclusion criteria for emergency room clinical staff: MD/DO/PA with a primary area of
      practice as emergency medicine or urgent care and area(s) of practice as emergency medicine,
      urgent care, family medicine, or adolescent & young adult medicine All DO (n = 191) will be
      surveyed. A stratified random sample (n= 400) of MD's (N = 1407) and PA's will be selected
      from the list using region of the state as the stratification factor.

      Qualtrics Survey:

      The survey will be divided into two general areas: 1) personal and practice demographics
      (sex, age, time in practice (years), practice size) and 2) clinical scenarios typical of
      patients seen by the respective practitioners who might be expected to experience acute pain.
      For each of the scenarios, practitioners will be asked the type(s) of medication that would
      be prescribed, the strength in mg, and the number of doses for each medication.

      The survey will be pre-tested by a sample of potential survey subjects who will be asked to
      provide open-ended comments regarding ease of completion, confusing items, and word changes.
      The survey methods of Salant and Dillman will be used as a guide.(8)

      A Qualtics linkage file will be created accessible only to the project investigators. The
      linkage file will only be used to identify non-respondents for follow-up. Surveys will be
      coded to maintain respondents' confidentiality. Linkage file will be in a pass word protected
      file separate from survey responses.

      Distribution:

      A mixed mode of distribution of the surveys will be used. Qualtrics software (Qualtrics,
      Provo, UT) will be used to create electronic versions of the survey to be sent to providers
      via email with an accompanying letter describing the purpose of the project and how
      confidentiality will be maintained. Teleform (Cardiff Software, Vista, CA) will be used as a
      paper alternative for providers who do not wish to respond to the electronic version. For
      these individuals a cover letter will be included describing the study along with a postage
      paid return envelope. Up to three attempts will be made at two-week intervals, depending on
      response versus non-response, to optimize subject participation.(8) The mode for the third
      round will be determined by the response rate from each of the first two rounds.

      Statistical Analysis:

      All survey responses will be de-identified to maintain provider confidentiality. The
      electronic and Teleform responses will be merged and analyzed using SAS (version 9.4, Cary,
      NC). Respondents will be excluded from data analysis if they do not complete the data for the
      prescribing practices.The primary outcome variable will be the clinicians prescribing opioid
      drugs for each survey scenario or not. Secondary analyses will explore possible explanatory
      variables for the primary outcome. Bivariate analysis will be done by status (degree and
      practice mode) to explore the effect of the explanatory variables (age; gender; time in
      practice; practice location; and practice size) on the preferred medication option for each
      clinical scenario. Comparisons among degree/specialty holders is not possible given that the
      scenarios presented are unique to the different groups. The use of Chi-square or Fisher's
      Exact test for the bivariate analysis will be determined based on the cell frequencies. Level
      of significance was set at 0.05.
observational model: Other
time perspective: Prospective
measure: Number of Clinicians Prescribing Opioid Drugs for each Survey Scenario
time frame: one year
description: Qualtrics Survey of NC Clinicians with DEA registration. Yes/No responses for opioid drug prescribing for 2 to 3 scenarios differing by target group of clinicians will be asked of 6 different clinician types, emergency room physicians, general dentists and dental specialists..
arm group label: NC Clinicians
description: Qualtrics Survey of NC Clinicians with DEA registration
intervention type: Other
intervention name: Qualtrics survey questions
description: Qualtrics Survey:
For each of the scenarios, practitioners will be asked whether opioids are prescribed or not, and the type(s) of other analgesic medications that would be prescribed, the strength in mg, and the number of doses for each medication
arm group label: NC Clinicians
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raymond P White, Jr, DDS. PhD
role: Study Director
affiliation: Oral and Maxillofacial Surgery, UNC School of Dentistry
last name: Glenn Reside, DMD
role: Principal Investigator
affiliation: Oral and Maxillofacial Surgery, UNC School of Dentistry
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Deidentified data that supports results will be shared provided the investigator who proposes use of the data has Institutional Review Board(IRB), Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with UNC
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: beginning 9 to 36 months following publication
ipd access criteria: Institutional Review Board(IRB), Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with UNC
ipd url: https://research.unc.edu/clinical-trials/clinical-trials-gov/data-sharing-guidance/).