<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/NCT04498559</url>
  </required_header>
  <id_info>
    <org_study_id>2019-2246</org_study_id>
    <nct_id>NCT04498559</nct_id>
  </id_info>
  <brief_title>Pain Management and Safe Opioid Use</brief_title>
  <official_title>Evaluating Patient Knowledge of Pain Management and Safe Opioid Use Before Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</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 purpose of this study is to examine what patients currently know about opioids, including&#xD;
      their role in pain management, side effects, risks of abuse, and proper storage and disposal.&#xD;
      It is critical for patients to be properly informed about opioid usage in treating&#xD;
      postoperative pain, but current gaps in patient knowledge are not well understood.&#xD;
&#xD;
      This study will help identify knowledge deficiencies and guide future patient education.&#xD;
      Additionally, this study will examine possible patient factors that may be associated with&#xD;
      these gaps. Evaluation of patient knowledge will be assessed through interviews conducted&#xD;
      before patients' day of surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2020</start_date>
  <completion_date type="Actual">December 12, 2020</completion_date>
  <primary_completion_date type="Actual">December 12, 2020</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>Patient's knowledge about opioids based on a qualitative assessment</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Patient's answers to opioid-related questions will be summarized using grounded theory, and a comparative analytic strategy to categories. A PI-provided scoring manual will also be used to quantify the accuracy and level of patients' knowledge about opioids. Reference: Berkwits M, Inui TS. Making use of qualitative research techniques. J Gen Intern Med. 1998;13(3):195-199. doi:10.1046/j.1525-1497.1998.00054.x</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Is the age the of patient associated with patients' knowledge of opioids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sex</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Is the sex of the patient associated with patients' knowledge of opioids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Race</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Is the race of the patient associated with patients' knowledge of opioids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ethnicity</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Is the ethnicity of the patient associated with patients' knowledge of opioids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Previous surgeries</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Are previous surgeries of the patient associated with patients' knowledge of opioids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Previous opioid usage</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Is the previous opioid usage of patient associated with patients' knowledge of opioids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Education level</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Is the education level of the patient associated with patients' knowledge of opioids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occupation</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Is the occupation of the patient associated with patients' knowledge of opioids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol and tobacco use</measure>
    <time_frame>Prior to surgery</time_frame>
    <description>Is the alcohol and tobacco use of the patient associated with patients' knowledge of opioids</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">128</enrollment>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Patients undergoing total hip replacement</arm_group_label>
    <description>Patients at HSS Main Campus undergoing primary total hip replacement surgery, age range between 18 and 80 years old, and English speaking</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing primary total hip replacement surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range between 18 and 80 years old&#xD;
&#xD;
          -  Undergoing primary total hip replacement surgery&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical background (profession that involves the prescribing, dispensing, handling, or&#xD;
             administering of opioids)&#xD;
&#xD;
          -  History of chronic opioid use (continuous opioid use for 3 or more months)&#xD;
&#xD;
          -  Opioid use within the past 3 months&#xD;
&#xD;
          -  Non-English speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bradley H Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 36 months after publication</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide methodologically sound proposal&#xD;
To achieve aims in the approved protocol&#xD;
Proposals should be directed to leeb@hss.edu. Proposals may be submitted up to 36 months after article publication. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT04498559
org study id: 2019-2246
nct id: NCT04498559
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine what patients currently know about opioids, including
      their role in pain management, side effects, risks of abuse, and proper storage and disposal.
      It is critical for patients to be properly informed about opioid usage in treating
      postoperative pain, but current gaps in patient knowledge are not well understood.

      This study will help identify knowledge deficiencies and guide future patient education.
      Additionally, this study will examine possible patient factors that may be associated with
      these gaps. Evaluation of patient knowledge will be assessed through interviews conducted
      before patients' day of surgery.
observational model: Other
time perspective: Prospective
measure: Patient's knowledge about opioids based on a qualitative assessment
time frame: Prior to surgery
description: Patient's answers to opioid-related questions will be summarized using grounded theory, and a comparative analytic strategy to categories. A PI-provided scoring manual will also be used to quantify the accuracy and level of patients' knowledge about opioids. Reference: Berkwits M, Inui TS. Making use of qualitative research techniques. J Gen Intern Med. 1998;13(3):195-199. doi:10.1046/j.1525-1497.1998.00054.x
measure: Age
time frame: Prior to surgery
description: Is the age the of patient associated with patients' knowledge of opioids
measure: Sex
time frame: Prior to surgery
description: Is the sex of the patient associated with patients' knowledge of opioids
measure: Race
time frame: Prior to surgery
description: Is the race of the patient associated with patients' knowledge of opioids
measure: Ethnicity
time frame: Prior to surgery
description: Is the ethnicity of the patient associated with patients' knowledge of opioids
measure: Previous surgeries
time frame: Prior to surgery
description: Are previous surgeries of the patient associated with patients' knowledge of opioids
measure: Previous opioid usage
time frame: Prior to surgery
description: Is the previous opioid usage of patient associated with patients' knowledge of opioids
measure: Education level
time frame: Prior to surgery
description: Is the education level of the patient associated with patients' knowledge of opioids
measure: Occupation
time frame: Prior to surgery
description: Is the occupation of the patient associated with patients' knowledge of opioids
measure: Alcohol and tobacco use
time frame: Prior to surgery
description: Is the alcohol and tobacco use of the patient associated with patients' knowledge of opioids
arm group label: Patients undergoing total hip replacement
description: Patients at HSS Main Campus undergoing primary total hip replacement surgery, age range between 18 and 80 years old, and English speaking
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bradley H Lee, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification
ipd info type: Study Protocol
ipd time frame: Beginning 3 months and ending 36 months after publication
ipd access criteria: Researchers who provide methodologically sound proposal
To achieve aims in the approved protocol
Proposals should be directed to leeb@hss.edu. Proposals may be submitted up to 36 months after article publication. To gain access, data requestors will need to sign a data access agreement.