<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/NCT02997644</url>
  </required_header>
  <id_info>
    <org_study_id>C.2016.142d</org_study_id>
    <nct_id>NCT02997644</nct_id>
  </id_info>
  <brief_title>Impact of Different Educational Approaches on Post-operative Opiate Utilization After Elective Lower Extremity Surgery</brief_title>
  <acronym>OpiateLEO</acronym>
  <official_title>The Effect of an Educational Pain Approach Before Elective Lower-extremity Surgery on 6-month Post-operative Use of Opioid Medication: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brooke Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brooke Army Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the use of post-operative opioid use after two&#xD;
      different educational interventions. The investigators will compare changes in pain,&#xD;
      disability and sleep between groups 6 months after elective lower extremity surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis: The primary hypothesis is that the educational intervention provided prior to the&#xD;
      surgery and prior to the prescription, will result in a greater understanding and awareness&#xD;
      of the deleterious effects of long-term use of opioid based medications, and in turn reduce&#xD;
      utilization post-operatively in the long-term (6 months).&#xD;
&#xD;
      Specific Aim 1: Evaluate prescription opioid medication use for the 6-month period after&#xD;
      surgery in subjects that received the education compared to those that received usual care&#xD;
      education.&#xD;
&#xD;
      Specific Aim 2: Compare the changes in self-reported outcome measures (pain, disability, and&#xD;
      sleep) between groups over the 6-month period after surgery.&#xD;
&#xD;
      Specific Aim 3: Describe the sociodemographic factors and healthcare utilization in enrolled&#xD;
      subjects for the 12 months leading up to a surgical procedure. Identify factors that could&#xD;
      account for differences in opioid medication utilization, and any potential interaction&#xD;
      effect between intervention, opioid use, and clinical outcomes following surgery.&#xD;
&#xD;
      Study Procedures/Research Interventions:&#xD;
&#xD;
      Subjects will be randomized to either receive usual care only or usual care plus the&#xD;
      education video. Usual care is defined as typical information the surgeon would otherwise&#xD;
      provide the patient before surgery. All patients will receive the usual care education from&#xD;
      their surgeon.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Subjects will then be randomized into one of two arms (Group I = Educational Video, Group II=&#xD;
      Usual Care Only). The method of group assignment will be sequentially numbered opaque sealed&#xD;
      envelopes (SNOSE). To minimize the risk of predicting the treatment assignment of the next&#xD;
      eligible patient, randomization will be performed in permuted blocks of two or four with&#xD;
      random variation of the blocking number.&#xD;
&#xD;
      All Subjects:&#xD;
&#xD;
      All subjects will receive the usual care education that is typically given by their surgeon.&#xD;
      That will be left up to the discretion of each surgeon. The screening and enrollment should&#xD;
      take no more than 5-10 minutes, and then the filling out of self-report questionnaires should&#xD;
      take approximately 5-7 minutes. Subjects in the group that is randomized to the education&#xD;
      will take an additional 11 minutes to view the educational content.&#xD;
&#xD;
      All patients will proceed with the surgical procedure as planned. Each week during the&#xD;
      1-month period after the surgery, patients will be contacted (phone call, email, and text&#xD;
      message - depending on what they consented to).&#xD;
&#xD;
      At the 1-month and 6-month time points they will be asked to fill out the additional clinical&#xD;
      outcomes measures detailed below. These can be done in person with a visit to the clinic or&#xD;
      over the telephone.&#xD;
&#xD;
      Sample Size Estimation. Collection of healthcare utilization will occur in 100% of the&#xD;
      subjects as no follow-up is required, and therefore no opportunities to collect data from a&#xD;
      follow-up visit will be lost. A sample of 120 subjects should allow us to determine&#xD;
      significant differences between groups, based on a moderate effect size of 0.6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opiate Prescriptions</measure>
    <time_frame>6 months</time_frame>
    <description>Total opiate prescriptions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>baseline, 1 month, 6 months</time_frame>
    <description>A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess LBP intensity. Numeric pain scales are known to have excellent test-retest reliability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS-29</measure>
    <time_frame>baseline, 1 month, 6 months</time_frame>
    <description>The Patient Reported Outcomes Measurement Information Systems (PROMIS) 29-item short form (version 2) to assess disability. The PROMIS 29-item short form efficiently assesses several outcomes important to patients with a neuromusculoskeletal injury, including pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input. The PROMIS-29 scores have been found valid for patients with orthopedic injuries, with minimum clinically important change thresholds of 2-4 points for most scales. It has also been used to successfully measure psychosocial resiliency in patients with disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Knee Injuries and Disorders</condition>
  <condition>Hip Injuries and Disorders</condition>
  <condition>Opiate Addiction</condition>
  <arm_group>
    <arm_group_label>Video Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Video education delivered on a tablet computer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Regular information about opioid usage they typically receive from their surgeon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video Education</intervention_name>
    <description>The content of the education focuses on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage.&#xD;
The consent, enrollment, and video education will take about 20-30 minutes for patients in this group, and occur at the end of their preoperative visit. The patient will watch the video on a portable Tablet computer.</description>
    <arm_group_label>Video Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care Group</intervention_name>
    <description>Patients that are randomized to usual care will only receive the regular instructions about opioid usage they typically receive from their surgeon.</description>
    <arm_group_label>Usual Care Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any Tricare-eligible patient scheduled for a pre-operative surgery appointment for an&#xD;
             elective orthopaedic surgery of the hip, knee, or foot/ankle at SAMMC.&#xD;
&#xD;
          2. The surgery is taking place for a condition that has been ongoing for 6 months or&#xD;
             longer (chronic)&#xD;
&#xD;
          3. Between the age of 18 - 65 years&#xD;
&#xD;
          4. Read and speak English well enough to understand the education, provide informed&#xD;
             consent and follow study instructions (the surgeon, investigators, or research&#xD;
             assistants will make this determination. Any patient that needs an interpreter will&#xD;
             not be allowed to enroll).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known aversion or allergy that would prevent the patient from taking any opioid-based&#xD;
             pain medication (any contraindications to using opioids)&#xD;
&#xD;
          2. History of prior surgery to the same location.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Rhon, DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brooke Army Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brooke Army Medical Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>French MT, McGeary KA, Chitwood DD, McCoy CB. Chronic illicit drug use, health services utilization and the cost of medical care. Soc Sci Med. 2000 Jun;50(12):1703-13. doi: 10.1016/s0277-9536(99)00411-6.</citation>
    <PMID>10798326</PMID>
  </reference>
  <reference>
    <citation>Songer TJ, LaPorte RE. Disabilities due to injury in the military. Am J Prev Med. 2000 Apr;18(3 Suppl):33-40. doi: 10.1016/s0749-3797(00)00107-0.</citation>
    <PMID>10736539</PMID>
  </reference>
  <reference>
    <citation>Vanderlip ER, Sullivan MD, Edlund MJ, Martin BC, Fortney J, Austen M, Williams JS, Hudson T. National study of discontinuation of long-term opioid therapy among veterans. Pain. 2014 Dec;155(12):2673-2679. doi: 10.1016/j.pain.2014.09.034. Epub 2014 Sep 30.</citation>
    <PMID>25277462</PMID>
  </reference>
  <reference>
    <citation>Toblin RL, Quartana PJ, Riviere LA, Walper KC, Hoge CW. Chronic pain and opioid use in US soldiers after combat deployment. JAMA Intern Med. 2014 Aug;174(8):1400-1. doi: 10.1001/jamainternmed.2014.2726. No abstract available.</citation>
    <PMID>24978399</PMID>
  </reference>
  <reference>
    <citation>Rozet I, Nishio I, Robbertze R, Rotter D, Chansky H, Hernandez AV. Prolonged opioid use after knee arthroscopy in military veterans. Anesth Analg. 2014 Aug;119(2):454-459. doi: 10.1213/ANE.0000000000000292.</citation>
    <PMID>24977636</PMID>
  </reference>
  <reference>
    <citation>Dobscha SK, Morasco BJ, Duckart JP, Macey T, Deyo RA. Correlates of prescription opioid initiation and long-term opioid use in veterans with persistent pain. Clin J Pain. 2013 Feb;29(2):102-8. doi: 10.1097/AJP.0b013e3182490bdb.</citation>
    <PMID>23269280</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>January 16, 2020</last_update_submitted>
  <last_update_submitted_qc>January 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brooke Army Medical Center</investigator_affiliation>
    <investigator_full_name>Dan Rhon</investigator_full_name>
    <investigator_title>Senior Scientist, Center for the Intrepid</investigator_title>
  </responsible_party>
  <keyword>patient education</keyword>
  <keyword>orthopaedic surgery</keyword>
  <keyword>post-surgical pain</keyword>
  <keyword>chronic opioid use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Knee Injuries</mesh_term>
    <mesh_term>Hip Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data sharing must go through a Data Sharing Agreement via the Defense Health Agency</ipd_description>
    <ipd_time_frame>Usually 1 year, but agreement is contract-specific with the Defense Health Agency</ipd_time_frame>
    <ipd_access_criteria>Submit a Data Sharing Agreement Application through the DHA</ipd_access_criteria>
    <ipd_url>https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application</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/NCT02997644
org study id: C.2016.142d
nct id: NCT02997644
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the use of post-operative opioid use after two
      different educational interventions. The investigators will compare changes in pain,
      disability and sleep between groups 6 months after elective lower extremity surgery.
Hypothesis: The primary hypothesis is that the educational intervention provided prior to the
      surgery and prior to the prescription, will result in a greater understanding and awareness
      of the deleterious effects of long-term use of opioid based medications, and in turn reduce
      utilization post-operatively in the long-term (6 months).

      Specific Aim 1: Evaluate prescription opioid medication use for the 6-month period after
      surgery in subjects that received the education compared to those that received usual care
      education.

      Specific Aim 2: Compare the changes in self-reported outcome measures (pain, disability, and
      sleep) between groups over the 6-month period after surgery.

      Specific Aim 3: Describe the sociodemographic factors and healthcare utilization in enrolled
      subjects for the 12 months leading up to a surgical procedure. Identify factors that could
      account for differences in opioid medication utilization, and any potential interaction
      effect between intervention, opioid use, and clinical outcomes following surgery.

      Study Procedures/Research Interventions:

      Subjects will be randomized to either receive usual care only or usual care plus the
      education video. Usual care is defined as typical information the surgeon would otherwise
      provide the patient before surgery. All patients will receive the usual care education from
      their surgeon.

      Randomization:

      Subjects will then be randomized into one of two arms (Group I = Educational Video, Group II=
      Usual Care Only). The method of group assignment will be sequentially numbered opaque sealed
      envelopes (SNOSE). To minimize the risk of predicting the treatment assignment of the next
      eligible patient, randomization will be performed in permuted blocks of two or four with
      random variation of the blocking number.

      All Subjects:

      All subjects will receive the usual care education that is typically given by their surgeon.
      That will be left up to the discretion of each surgeon. The screening and enrollment should
      take no more than 5-10 minutes, and then the filling out of self-report questionnaires should
      take approximately 5-7 minutes. Subjects in the group that is randomized to the education
      will take an additional 11 minutes to view the educational content.

      All patients will proceed with the surgical procedure as planned. Each week during the
      1-month period after the surgery, patients will be contacted (phone call, email, and text
      message - depending on what they consented to).

      At the 1-month and 6-month time points they will be asked to fill out the additional clinical
      outcomes measures detailed below. These can be done in person with a visit to the clinic or
      over the telephone.

      Sample Size Estimation. Collection of healthcare utilization will occur in 100% of the
      subjects as no follow-up is required, and therefore no opportunities to collect data from a
      follow-up visit will be lost. A sample of 120 subjects should allow us to determine
      significant differences between groups, based on a moderate effect size of 0.6.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Opiate Prescriptions
time frame: 6 months
description: Total opiate prescriptions
measure: Numeric Pain Rating Scale
time frame: baseline, 1 month, 6 months
description: A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess LBP intensity. Numeric pain scales are known to have excellent test-retest reliability.
measure: PROMIS-29
time frame: baseline, 1 month, 6 months
description: The Patient Reported Outcomes Measurement Information Systems (PROMIS) 29-item short form (version 2) to assess disability. The PROMIS 29-item short form efficiently assesses several outcomes important to patients with a neuromusculoskeletal injury, including pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input. The PROMIS-29 scores have been found valid for patients with orthopedic injuries, with minimum clinically important change thresholds of 2-4 points for most scales. It has also been used to successfully measure psychosocial resiliency in patients with disability.
arm group label: Video Education
arm group type: Experimental
description: Video education delivered on a tablet computer
arm group label: Usual Care Group
arm group type: Placebo Comparator
description: Regular information about opioid usage they typically receive from their surgeon.
intervention type: Behavioral
intervention name: Video Education
description: The content of the education focuses on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage.
The consent, enrollment, and video education will take about 20-30 minutes for patients in this group, and occur at the end of their preoperative visit. The patient will watch the video on a portable Tablet computer.
arm group label: Video Education
intervention type: Behavioral
intervention name: Usual Care Group
description: Patients that are randomized to usual care will only receive the regular instructions about opioid usage they typically receive from their surgeon.
arm group label: Usual Care Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Daniel Rhon, DSc
role: Principal Investigator
affiliation: Brooke Army Medical Center
facility: 
country: United States
citation: French MT, McGeary KA, Chitwood DD, McCoy CB. Chronic illicit drug use, health services utilization and the cost of medical care. Soc Sci Med. 2000 Jun;50(12):1703-13. doi: 10.1016/s0277-9536(99)00411-6.
PMID: 10798326
citation: Songer TJ, LaPorte RE. Disabilities due to injury in the military. Am J Prev Med. 2000 Apr;18(3 Suppl):33-40. doi: 10.1016/s0749-3797(00)00107-0.
PMID: 10736539
citation: Vanderlip ER, Sullivan MD, Edlund MJ, Martin BC, Fortney J, Austen M, Williams JS, Hudson T. National study of discontinuation of long-term opioid therapy among veterans. Pain. 2014 Dec;155(12):2673-2679. doi: 10.1016/j.pain.2014.09.034. Epub 2014 Sep 30.
PMID: 25277462
citation: Toblin RL, Quartana PJ, Riviere LA, Walper KC, Hoge CW. Chronic pain and opioid use in US soldiers after combat deployment. JAMA Intern Med. 2014 Aug;174(8):1400-1. doi: 10.1001/jamainternmed.2014.2726. No abstract available.
PMID: 24978399
citation: Rozet I, Nishio I, Robbertze R, Rotter D, Chansky H, Hernandez AV. Prolonged opioid use after knee arthroscopy in military veterans. Anesth Analg. 2014 Aug;119(2):454-459. doi: 10.1213/ANE.0000000000000292.
PMID: 24977636
citation: Dobscha SK, Morasco BJ, Duckart JP, Macey T, Deyo RA. Correlates of prescription opioid initiation and long-term opioid use in veterans with persistent pain. Clin J Pain. 2013 Feb;29(2):102-8. doi: 10.1097/AJP.0b013e3182490bdb.
PMID: 23269280
responsible party type: Principal Investigator
investigator affiliation: Brooke Army Medical Center
investigator full name: Dan Rhon
investigator title: Senior Scientist, Center for the Intrepid
mesh term: Opioid-Related Disorders
mesh term: Wounds and Injuries
mesh term: Knee Injuries
mesh term: Hip Injuries
sharing ipd: Yes
ipd description: Data sharing must go through a Data Sharing Agreement via the Defense Health Agency
ipd time frame: Usually 1 year, but agreement is contract-specific with the Defense Health Agency
ipd access criteria: Submit a Data Sharing Agreement Application through the DHA
ipd url: https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application