<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/NCT03836235</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201802137- N</org_study_id>
    <secondary_id>R33AG056540</secondary_id>
    <secondary_id>JAX ASCENT Junior Scholar</secondary_id>
    <nct_id>NCT03836235</nct_id>
  </id_info>
  <brief_title>Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department</brief_title>
  <acronym>STOP Injury</acronym>
  <official_title>Development of a Risk Prediction Screening Tool for Opioid-Prescription Injury (STOP Injury) in Older Adults Initiated on Opioids From the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>US Department of Health and Human Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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 long-term goal of this project is to promote responsible opioid prescribing, immediately&#xD;
      improving patient safety and ultimately decreasing healthcare costs by reducing older adult&#xD;
      morbidity and mortality due to opioid-related injury. The objective of this pilot project is&#xD;
      to gather data to inform the development of the STOP Injury tool and evaluate additional&#xD;
      predictive factors and important outcomes relevant to prescription opioids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The experience from this project will lay the groundwork on prospective validation of STOP&#xD;
      Injury in a large appropriately powered study. Aim 1 will provide data that will help narrow&#xD;
      inclusion of candidate variables in the STOP Injury tool to include those that are most&#xD;
      feasible to collect and most predictive. Aim 2 will help inform the possible inclusion of&#xD;
      genetic factors into a predictive model. Finally, Aim 3 will help identify quality of life&#xD;
      outcomes that should be considered when assessing opioid medication adverse events.&#xD;
&#xD;
      Aim 1. Evaluate the association between prescription opioid adverse events in older adults&#xD;
      and candidate risk prediction variables proposed for STOP Injury prediction score The study&#xD;
      team will conduct a pilot prospective observational study of 200 patients 50 years or older&#xD;
      who are initiated on opioids from the emergency department (ED). The investigators will&#xD;
      analyze the association between candidate risk factors and opioid adverse events (falls and&#xD;
      OD).&#xD;
&#xD;
      Aim 2. Evaluate the association between prescription opioid adverse events and genetic&#xD;
      factors.&#xD;
&#xD;
      In the cohort from Aim 1, the study team will test subjects for 12 genetic single nucleotide&#xD;
      polymorphisms related to opioid metabolism, transport, and effect.&#xD;
&#xD;
      Aim 3. Measure the impact of opioid medications on quality of life measures in older adults&#xD;
      The investigators will implement a series of quality of life measures on a subset of patients&#xD;
      as a pilot study to determine which measures capture the impact prescription opioids have on&#xD;
      older adults' quality of life&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Actual">April 3, 2020</completion_date>
  <primary_completion_date type="Actual">April 3, 2020</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>Safety, as measured by number of subjects with at least one fall adverse event</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>The study team will analyze the association between candidate risk factors and opioid adverse events (falls and OD).</description>
  </primary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>Opioid Use</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Mouthwash samples will be used to test for the presence of single-nucleotide polymorphisms&#xD;
      (CYP2D6, OPRM1, COMT, ABCB1, OCT1) in the genes that mediate opioid metabolism.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study will seek to enroll 200 subjects. All patients 50 years or older presenting to UF&#xD;
        JAX ED with pain or a pain-related complaint (i.e., fracture, burn, etc.) will be screened&#xD;
        for eligibility using the inclusion and exclusion criteria listed below. To accomplish Aim&#xD;
        3, the investigators will enroll a convenience subset of patients by approaching every&#xD;
        third subject enrolled with the option to consent for Aim 3.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presenting to UF JAX ED with pain or a pain-related complaint (i.e., fracture, burn,&#xD;
             etc.)&#xD;
&#xD;
          -  Patient has not used opioids 15 days or more within the last 30 days&#xD;
&#xD;
          -  Patient does not have opioid medications at home&#xD;
&#xD;
          -  Discharge to home with an opioid prescription&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bed-bound or uses wheelchair&#xD;
&#xD;
          -  Living in skilled nursing facility or assisted living facility&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Unable to provide consent&#xD;
&#xD;
          -  Incarcerated&#xD;
&#xD;
          -  Lack of reliable telephone access&#xD;
&#xD;
          -  Use of opioids on most days for &gt;3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sophia Sheikh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UF College of Medicine--Jacksonville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>October 12, 2020</last_update_submitted>
  <last_update_submitted_qc>October 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>older adults</keyword>
  <keyword>quality of life</keyword>
  <keyword>adverse events</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03836235
org study id: IRB201802137- N
secondary id: R33AG056540
secondary id: JAX ASCENT Junior Scholar
nct id: NCT03836235
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The long-term goal of this project is to promote responsible opioid prescribing, immediately
      improving patient safety and ultimately decreasing healthcare costs by reducing older adult
      morbidity and mortality due to opioid-related injury. The objective of this pilot project is
      to gather data to inform the development of the STOP Injury tool and evaluate additional
      predictive factors and important outcomes relevant to prescription opioids.
The experience from this project will lay the groundwork on prospective validation of STOP
      Injury in a large appropriately powered study. Aim 1 will provide data that will help narrow
      inclusion of candidate variables in the STOP Injury tool to include those that are most
      feasible to collect and most predictive. Aim 2 will help inform the possible inclusion of
      genetic factors into a predictive model. Finally, Aim 3 will help identify quality of life
      outcomes that should be considered when assessing opioid medication adverse events.

      Aim 1. Evaluate the association between prescription opioid adverse events in older adults
      and candidate risk prediction variables proposed for STOP Injury prediction score The study
      team will conduct a pilot prospective observational study of 200 patients 50 years or older
      who are initiated on opioids from the emergency department (ED). The investigators will
      analyze the association between candidate risk factors and opioid adverse events (falls and
      OD).

      Aim 2. Evaluate the association between prescription opioid adverse events and genetic
      factors.

      In the cohort from Aim 1, the study team will test subjects for 12 genetic single nucleotide
      polymorphisms related to opioid metabolism, transport, and effect.

      Aim 3. Measure the impact of opioid medications on quality of life measures in older adults
      The investigators will implement a series of quality of life measures on a subset of patients
      as a pilot study to determine which measures capture the impact prescription opioids have on
      older adults' quality of life
observational model: Cohort
time perspective: Prospective
measure: Safety, as measured by number of subjects with at least one fall adverse event
time frame: Up to 30 days
description: The study team will analyze the association between candidate risk factors and opioid adverse events (falls and OD).
Mouthwash samples will be used to test for the presence of single-nucleotide polymorphisms
      (CYP2D6, OPRM1, COMT, ABCB1, OCT1) in the genes that mediate opioid metabolism.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 120 Years
healthy volunteers: No
last name: Sophia Sheikh, MD
role: Principal Investigator
affiliation: UF College of Medicine--Jacksonville
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No