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Appropriate Opioid Quantities for Acute Pain - Pharmacist Study

Primary Purpose

Opioid Use, Acute Pain

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Use focused on measuring opioid, acute pain, pharmacist, pharmacy practice

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any pharmacist working in a community pharmacy in the intervention regions.
  • Any patient seeking to fill an opioid prescription for acute pain at a pharmacy in the intervention regions.

Exclusion Criteria:

  • None

Sites / Locations

  • Beth Sproule

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Appropriate Opioid Quantities

Usual Practice

Arm 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.

Pharmacists in the comparison regions are not targeted for the practice change intervention (they are not invited nor provided access to the eLearning program).

Outcomes

Primary Outcome Measures

Opioid Quantities Dispensed
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.

Secondary Outcome Measures

Opioid Doses Dispensed
Percentage of patients who were newly dispensed an opioid prescription greater than 50 milligram morphine equivalents (MME) per day.
Subsequent Opioid Dispensing
Frequency of dispensing remaining quantities from part-filled prescriptions and ongoing opioid dispensing.
Opioid Quantity Changes per Pharmacy, Pharmacist and Prescriber
Number of pharmacies, pharmacists and prescribers for which there were significant pre-post intervention changes in opioid quantities.
Prescription costs
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.
Indication for opioid
Types of indications for opioid prescriptions.
Pharmacists opinions, attitudes, comfort level and actions
Survey
Patient experiences
Survey
Prescriber experiences
Survey

Full Information

First Posted
July 21, 2020
Last Updated
July 19, 2022
Sponsor
Centre for Addiction and Mental Health
Collaborators
Institute of Safe Medication Practices Canada, North York General Hospital, The Royal Ottawa Mental Health Centre, Ontario Drug Policy Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT04484610
Brief Title
Appropriate Opioid Quantities for Acute Pain - Pharmacist Study
Official Title
Providing Appropriate Opioid Prescription Quantities for Acute Pain Treatment: A Cluster Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
February 21, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Institute of Safe Medication Practices Canada, North York General Hospital, The Royal Ottawa Mental Health Centre, Ontario Drug Policy Research Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 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. To measure pharmacist uptake of the intervention. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Acute Pain
Keywords
opioid, acute pain, pharmacist, pharmacy practice

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Appropriate Opioid Quantities
Arm Type
Experimental
Arm 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 Title
Usual Practice
Arm Type
No Intervention
Arm 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(s)
Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain
Intervention Description
Pharmacist eLearning modules, support tools and resources to promote assessing and dispensing appropriate opioid quantities for acute pain.
Primary Outcome Measure Information:
Title
Opioid Quantities Dispensed
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Opioid Doses Dispensed
Description
Percentage of patients who were newly dispensed an opioid prescription greater than 50 milligram morphine equivalents (MME) per day.
Time Frame
After 6 months
Title
Subsequent Opioid Dispensing
Description
Frequency of dispensing remaining quantities from part-filled prescriptions and ongoing opioid dispensing.
Time Frame
6 months
Title
Opioid Quantity Changes per Pharmacy, Pharmacist and Prescriber
Description
Number of pharmacies, pharmacists and prescribers for which there were significant pre-post intervention changes in opioid quantities.
Time Frame
6 months
Title
Prescription costs
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.
Time Frame
6 months
Title
Indication for opioid
Description
Types of indications for opioid prescriptions.
Time Frame
6 months
Title
Pharmacists opinions, attitudes, comfort level and actions
Description
Survey
Time Frame
Before and after opioid quantity education and after 6 months
Title
Patient experiences
Description
Survey
Time Frame
After interaction with pharmacist.
Title
Prescriber experiences
Description
Survey
Time Frame
After 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any pharmacist working in a community pharmacy in the intervention regions. Any patient seeking to fill an opioid prescription for acute pain at a pharmacy in the intervention regions. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Sproule, PharmD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Sproule
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Appropriate Opioid Quantities for Acute Pain - Pharmacist Study

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