Appropriate Opioid Quantities for Acute Pain - Pharmacist Study

NCT ID: NCT04484610

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2022-03-31

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

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.

Conditions

Opioid Use; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain

Intervention Type: DRUG

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

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Safe Medication Practices Canada

UNKNOWN

Sponsor Role: collaborator

North York General Hospital

OTHER

Sponsor Role: collaborator

The Royal Ottawa Mental Health Centre

OTHER

Sponsor Role: collaborator

Ontario Drug Policy Research Network

UNKNOWN

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beth Sproule, PharmD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Beth Sproule

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

002-2019

Identifier Type: -

Identifier Source: org_study_id