Appropriate Opioid Quantities for Acute Pain - Pharmacist Study

Providing Appropriate Opioid Prescription Quantities for Acute Pain Treatment: A Cluster Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain; Opioid Use
• Intervention / Treatment: Drug: Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain

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

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.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J 1H4
      • Beth Sproule

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Appropriate Opioid Quantities; 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; Pharmacist eLearning modules, support tools and resources to promote assessing and dispensing appropriate opioid quantities for acute pain.
NO_INTERVENTION: Usual Practice; Pharmacists in the comparison regions are not targeted for the practice change intervention (they are not invited nor provided access to the eLearning program).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Doses Dispensed	Percentage of patients who were newly dispensed an opioid prescription greater than 50 milligram morphine equivalents (MME) per day.	After 6 months
Subsequent Opioid Dispensing	Frequency of dispensing remaining quantities from part-filled prescriptions and ongoing opioid dispensing.	6 months
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.	6 months
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.	6 months
Indication for opioid	Types of indications for opioid prescriptions.	6 months
Pharmacists opinions, attitudes, comfort level and actions	Survey	Before and after opioid quantity education and after 6 months
Patient experiences	Survey	After interaction with pharmacist.
Prescriber experiences	Survey	After 6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2020
• Primary Completion (ACTUAL): February 21, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (ACTUAL): July 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: opioid; acute pain; pharmacist; pharmacy practice
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 002-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No