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OpenTrials
Completed

NCT Number: NCT04484610

Appropriate Opioid Quantities for Acute Pain - Pharmacist Study

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beth Sproule

Toronto, Ontario, M6J 1H4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Opioid Quantities Dispensed

    Time frame: 6 months

    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 outcomes

  1. Opioid Doses Dispensed

    Time frame: After 6 months

    Percentage of patients who were newly dispensed an opioid prescription greater than 50 milligram morphine equivalents (MME) per day.

  2. Subsequent Opioid Dispensing

    Time frame: 6 months

    Frequency of dispensing remaining quantities from part-filled prescriptions and ongoing opioid dispensing.

  3. Opioid Quantity Changes per Pharmacy, Pharmacist and Prescriber

    Time frame: 6 months

    Number of pharmacies, pharmacists and prescribers for which there were significant pre-post intervention changes in opioid quantities.

  4. Prescription costs

    Time frame: 6 months

    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.

  5. Indication for opioid

    Time frame: 6 months

    Types of indications for opioid prescriptions.

  6. Pharmacists opinions, attitudes, comfort level and actions

    Time frame: Before and after opioid quantity education and after 6 months

    Survey

  7. Patient experiences

    Time frame: After interaction with pharmacist.

    Survey

  8. Prescriber experiences

    Time frame: After 6 months

    Survey

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Institute of Safe Medication Practices Canada
  • North York General Hospital
  • Ontario Drug Policy Research Network
  • The Royal Ottawa Mental Health Centre

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2020
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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