<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/NCT04484610</url>
  </required_header>
  <id_info>
    <org_study_id>002-2019</org_study_id>
    <nct_id>NCT04484610</nct_id>
  </id_info>
  <brief_title>Appropriate Opioid Quantities for Acute Pain - Pharmacist Study</brief_title>
  <official_title>Providing Appropriate Opioid Prescription Quantities for Acute Pain Treatment: A Cluster Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Safe Medication Practices Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North York General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Royal Ottawa Mental Health Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ontario Drug Policy Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Addiction and Mental Health</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>
      Prescription opioids contribute to opioid related deaths, overdose and addiction. Unused&#xD;
      prescribed opioids are not routinely being stored or disposed of appropriately and their&#xD;
      availability is associated with harms. Maximum daily doses prescribed are higher than that&#xD;
      recommended in a significant number of patients. This study is designed to help have&#xD;
      appropriate doses and quantities of opioids dispensed for the treatment of short-term pain.&#xD;
      Rather than targeting prescribing, this study targets the dispensing process by training&#xD;
      community pharmacists to assess the appropriateness and safety of opioid prescriptions for&#xD;
      short-term pain and to work with patients to partially fill prescriptions if the quantities&#xD;
      prescribed are deemed excessive. Patient education tools were developed to help promote&#xD;
      understanding of opioid safety, including the use of appropriate quantities, safe storage and&#xD;
      safe disposal. Pharmacists in five randomly selected regions in Ontario, Canada are targeted&#xD;
      for the eLearning intervention. The primary study outcome is the quantities dispensed for&#xD;
      initial opioid prescriptions for short-term pain in the intervention regions compared to ten&#xD;
      control regions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed intervention is designed to implement and evaluate a pharmacist-led intervention&#xD;
      to promote dispensing appropriate doses and quantities of opioids for acute pain at the&#xD;
      initial prescription stage. This would include patients discharged from hospital&#xD;
      post-surgery, following emergency room visits, after dental procedures, and patients visiting&#xD;
      primary care prescribers. Thus it will capture a wide spectrum of prescribing. This study&#xD;
      focuses on incorporating into routine pharmacy practice the assessment and adjustment of&#xD;
      opioid doses and quantities for the treatment of acute pain to appropriate levels.&#xD;
      Pharmacists in Ontario are able to reduce the quantities of prescriptions with the agreement&#xD;
      of the patient. The remainder of the prescription quantity can remain active to be filled&#xD;
      subsequently if needed. By implementing the option of part-fills for prescriptions with&#xD;
      higher quantities, this intervention does allow patients to access more analgesia if their&#xD;
      pain management requires it.&#xD;
&#xD;
      Project Objectives&#xD;
&#xD;
        1. To develop, test, optimize and implement an intervention in 5 randomly selected regions&#xD;
           in Ontario to promote pharmacist-led practices to limit initial quantities of opioid&#xD;
           prescriptions to appropriate levels for the treatment of acute pain. The intervention&#xD;
           components include a pharmacist a training program, patient engagement tools and&#xD;
           prescriber engagement communication.&#xD;
&#xD;
        2. To measure pharmacist uptake of the intervention.&#xD;
&#xD;
        3. To compare initial prescription opioid quantities and daily doses in the intervention&#xD;
           regions to 10 matched control regions.&#xD;
&#xD;
      This is a prospective, cluster randomized controlled trial evaluating a 6-month pharmacy&#xD;
      practice intervention to limit initial doses and quantities of opioid prescriptions to&#xD;
      appropriate levels for the treatment of acute pain. The intervention components include a&#xD;
      pharmacist a training program, patient engagement tools and prescriber engagement&#xD;
      communication. The development of the intervention was informed by the systematic approach&#xD;
      described by French and colleagues (2012) for behaviour change interventions implementing&#xD;
      evidence into practice. The 5 eLearning modules (15-20 minutes each) and the patient&#xD;
      communication tools (patient handout and pharmacy poster) have undergone usability testing&#xD;
      using a human factors research approach prior to finalization. The intervention will be&#xD;
      implemented in 5 public health unit regions in Ontario randomly selected along with 10&#xD;
      matched (1:2) control public health unit regions. All community pharmacists in the&#xD;
      intervention regions will be invited to undertake the eLearning program to promote the&#xD;
      specific practice change related to opioid quantities. The primary outcome measure will be&#xD;
      the quantities of opioids dispensed to patients receiving initial prescriptions for the&#xD;
      treatment of acute pain. Analyses will be at the cluster level in which quantities dispensed&#xD;
      will be compared both between intervention and control public health unit regions after 6&#xD;
      months, and before and after implementation within intervention sites.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2020</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">February 21, 2022</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid Quantities Dispensed</measure>
    <time_frame>6 months</time_frame>
    <description>Quantities dispensed for initial opioid prescriptions from all pharmacies within the 5 intervention regions for all patients without previous opioid prescriptions in the last 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Doses Dispensed</measure>
    <time_frame>After 6 months</time_frame>
    <description>Percentage of patients who were newly dispensed an opioid prescription greater than 50 milligram morphine equivalents (MME) per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subsequent Opioid Dispensing</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency of dispensing remaining quantities from part-filled prescriptions and ongoing opioid dispensing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Quantity Changes per Pharmacy, Pharmacist and Prescriber</measure>
    <time_frame>6 months</time_frame>
    <description>Number of pharmacies, pharmacists and prescribers for which there were significant pre-post intervention changes in opioid quantities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescription costs</measure>
    <time_frame>6 months</time_frame>
    <description>Prescription cost changes related to dispensing smaller quantities: exploring the potential decreases in drug costs associated with reduced quantities, as well as potential increases in prescription costs related to extra dispensing fees for part-fill prescriptions requiring subsequent fills.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indication for opioid</measure>
    <time_frame>6 months</time_frame>
    <description>Types of indications for opioid prescriptions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacists opinions, attitudes, comfort level and actions</measure>
    <time_frame>Before and after opioid quantity education and after 6 months</time_frame>
    <description>Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experiences</measure>
    <time_frame>After interaction with pharmacist.</time_frame>
    <description>Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescriber experiences</measure>
    <time_frame>After 6 months</time_frame>
    <description>Survey</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">205</enrollment>
  <condition>Opioid Use</condition>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Appropriate Opioid Quantities</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pharmacists in the intervention regions are invited to complete an eLearning program to promote the practice change intervention of assessing and dispensing appropriate quantities of opioids prescribed for acute pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Practice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Pharmacists in the comparison regions are not targeted for the practice change intervention (they are not invited nor provided access to the eLearning program).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain</intervention_name>
    <description>Pharmacist eLearning modules, support tools and resources to promote assessing and dispensing appropriate opioid quantities for acute pain.</description>
    <arm_group_label>Appropriate Opioid Quantities</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any pharmacist working in a community pharmacy in the intervention regions.&#xD;
&#xD;
          -  Any patient seeking to fill an opioid prescription for acute pain at a pharmacy in the&#xD;
             intervention regions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beth Sproule, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Sproule</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6J 1H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>opioid</keyword>
  <keyword>acute pain</keyword>
  <keyword>pharmacist</keyword>
  <keyword>pharmacy practice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_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/NCT04484610
org study id: 002-2019
nct id: NCT04484610
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prescription opioids contribute to opioid related deaths, overdose and addiction. Unused
      prescribed opioids are not routinely being stored or disposed of appropriately and their
      availability is associated with harms. Maximum daily doses prescribed are higher than that
      recommended in a significant number of patients. This study is designed to help have
      appropriate doses and quantities of opioids dispensed for the treatment of short-term pain.
      Rather than targeting prescribing, this study targets the dispensing process by training
      community pharmacists to assess the appropriateness and safety of opioid prescriptions for
      short-term pain and to work with patients to partially fill prescriptions if the quantities
      prescribed are deemed excessive. Patient education tools were developed to help promote
      understanding of opioid safety, including the use of appropriate quantities, safe storage and
      safe disposal. Pharmacists in five randomly selected regions in Ontario, Canada are targeted
      for the eLearning intervention. The primary study outcome is the quantities dispensed for
      initial opioid prescriptions for short-term pain in the intervention regions compared to ten
      control regions.
The proposed intervention is designed to implement and evaluate a pharmacist-led intervention
      to promote dispensing appropriate doses and quantities of opioids for acute pain at the
      initial prescription stage. This would include patients discharged from hospital
      post-surgery, following emergency room visits, after dental procedures, and patients visiting
      primary care prescribers. Thus it will capture a wide spectrum of prescribing. This study
      focuses on incorporating into routine pharmacy practice the assessment and adjustment of
      opioid doses and quantities for the treatment of acute pain to appropriate levels.
      Pharmacists in Ontario are able to reduce the quantities of prescriptions with the agreement
      of the patient. The remainder of the prescription quantity can remain active to be filled
      subsequently if needed. By implementing the option of part-fills for prescriptions with
      higher quantities, this intervention does allow patients to access more analgesia if their
      pain management requires it.

      Project Objectives

        1. To develop, test, optimize and implement an intervention in 5 randomly selected regions
           in Ontario to promote pharmacist-led practices to limit initial quantities of opioid
           prescriptions to appropriate levels for the treatment of acute pain. The intervention
           components include a pharmacist a training program, patient engagement tools and
           prescriber engagement communication.

        2. To measure pharmacist uptake of the intervention.

        3. To compare initial prescription opioid quantities and daily doses in the intervention
           regions to 10 matched control regions.

      This is a prospective, cluster randomized controlled trial evaluating a 6-month pharmacy
      practice intervention to limit initial doses and quantities of opioid prescriptions to
      appropriate levels for the treatment of acute pain. The intervention components include a
      pharmacist a training program, patient engagement tools and prescriber engagement
      communication. The development of the intervention was informed by the systematic approach
      described by French and colleagues (2012) for behaviour change interventions implementing
      evidence into practice. The 5 eLearning modules (15-20 minutes each) and the patient
      communication tools (patient handout and pharmacy poster) have undergone usability testing
      using a human factors research approach prior to finalization. The intervention will be
      implemented in 5 public health unit regions in Ontario randomly selected along with 10
      matched (1:2) control public health unit regions. All community pharmacists in the
      intervention regions will be invited to undertake the eLearning program to promote the
      specific practice change related to opioid quantities. The primary outcome measure will be
      the quantities of opioids dispensed to patients receiving initial prescriptions for the
      treatment of acute pain. Analyses will be at the cluster level in which quantities dispensed
      will be compared both between intervention and control public health unit regions after 6
      months, and before and after implementation within intervention sites.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Opioid Quantities Dispensed
time frame: 6 months
description: Quantities dispensed for initial opioid prescriptions from all pharmacies within the 5 intervention regions for all patients without previous opioid prescriptions in the last 6 months.
measure: Opioid Doses Dispensed
time frame: After 6 months
description: Percentage of patients who were newly dispensed an opioid prescription greater than 50 milligram morphine equivalents (MME) per day.
measure: Subsequent Opioid Dispensing
time frame: 6 months
description: Frequency of dispensing remaining quantities from part-filled prescriptions and ongoing opioid dispensing.
measure: Opioid Quantity Changes per Pharmacy, Pharmacist and Prescriber
time frame: 6 months
description: Number of pharmacies, pharmacists and prescribers for which there were significant pre-post intervention changes in opioid quantities.
measure: Prescription costs
time frame: 6 months
description: Prescription cost changes related to dispensing smaller quantities: exploring the potential decreases in drug costs associated with reduced quantities, as well as potential increases in prescription costs related to extra dispensing fees for part-fill prescriptions requiring subsequent fills.
measure: Indication for opioid
time frame: 6 months
description: Types of indications for opioid prescriptions.
measure: Pharmacists opinions, attitudes, comfort level and actions
time frame: Before and after opioid quantity education and after 6 months
description: Survey
measure: Patient experiences
time frame: After interaction with pharmacist.
description: Survey
measure: Prescriber experiences
time frame: After 6 months
description: Survey
arm group label: Appropriate Opioid Quantities
arm group type: Experimental
description: Pharmacists in the intervention regions are invited to complete an eLearning program to promote the practice change intervention of assessing and dispensing appropriate quantities of opioids prescribed for acute pain.
arm group label: Usual Practice
arm group type: No Intervention
description: Pharmacists in the comparison regions are not targeted for the practice change intervention (they are not invited nor provided access to the eLearning program).
intervention type: Drug
intervention name: Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain
description: Pharmacist eLearning modules, support tools and resources to promote assessing and dispensing appropriate opioid quantities for acute pain.
arm group label: Appropriate Opioid Quantities
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Beth Sproule, PharmD
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Acute Pain
mesh term: Analgesics, Opioid
sharing ipd: No