Appropriate Opioid Quantities for Acute Pain - Pharmacist Study

NCT04484610 | Completed Phase 4

• 1 other identifier: 002-2019
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Acute Pain

Keywords

opioid; acute pain; pharmacist; pharmacy practice

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (8)

• Opioid Doses Dispensed

  After 6 months

• Subsequent Opioid Dispensing

  6 months

• Opioid Quantity Changes per Pharmacy, Pharmacist and Prescriber

  6 months

• Prescription costs

  6 months

• Indication for opioid

  6 months

Study Arms (2)

Appropriate Opioid Quantities

EXPERIMENTAL

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.

Drug: Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain

Usual Practice

NO INTERVENTION

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

Interventions

Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain DRUG

Pharmacist eLearning modules, support tools and resources to promote assessing and dispensing appropriate opioid quantities for acute pain.

Appropriate Opioid Quantities

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Institute of Safe Medication Practices Canada: collaborator
• North York General Hospital: collaborator
• The Royal Ottawa Mental Health Centre: collaborator
• Ontario Drug Policy Research Network: collaborator

Study Sites (1)

Beth Sproule

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beth Sproule, PharmD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: September 8, 2020
• Primary Completion: February 21, 2022
• Study Completion: March 31, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)