Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04484610 |
| Other study ID # |
002-2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
September 8, 2020 |
| Est. completion date |
March 31, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Centre for Addiction and Mental Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
