Clinical trial NCT04484610: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use
Acute Pain
Keywords: opioid
acute pain
pharmacist
pharmacy practice
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Institute of Safe Medication Practices Canada
name: North York General Hospital
name: The Royal Ottawa Mental Health Centre
name: Ontario Drug Policy Research Network
First posted: 2020-07-23
Enrollment: 205
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Opioid Quantities Dispensed
timeFrame: 6 months
Secondary outcomes:
measure: Opioid Doses Dispensed
timeFrame: After 6 months
measure: Subsequent Opioid Dispensing
timeFrame: 6 months
measure: Opioid Quantity Changes per Pharmacy, Pharmacist and Prescriber
timeFrame: 6 months
measure: Prescription costs
timeFrame: 6 months
measure: Indication for opioid
timeFrame: 6 months
measure: Pharmacists opinions, attitudes, comfort level and actions
timeFrame: Before and after opioid quantity education and after 6 months
measure: Patient experiences
timeFrame: After interaction with pharmacist.
measure: Prescriber experiences
timeFrame: After 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Beth Sproule
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Beth Sproule, PharmD
role: PRINCIPAL_INVESTIGATOR
References: