Opioid UsePhase 4NCT04484610
Appropriate Opioid Quantities for Acute Pain - Pharmacist Study
A Phase 4 study testing Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain in people with Opioid Use and Acute Pain, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid Use, Acute Pain
- What is being tested?
- Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2020to 31 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- 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.
- Conditions
- Opioid Use, Acute Pain
- Being tested
- Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain
- Keywords
- opioid, acute pain, pharmacist, pharmacy practice
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute PainDrug
Pharmacist eLearning modules, support tools and resources to promote assessing and dispensing appropriate opioid quantities for acute pain.
| Study group | Role | What they receive |
|---|---|---|
| Appropriate Opioid Quantities | Experimental | 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. Receives: Drug: Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain |
| Usual Practice | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
Opioid Doses Dispensed
Percentage of patients who were newly dispensed an opioid prescription greater than 50 milligram morphine equivalents (MME) per day.
Measured: After 6 months
Subsequent Opioid Dispensing
Frequency of dispensing remaining quantities from part-filled prescriptions and ongoing opioid dispensing.
Measured: 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.
Measured: 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.
Measured: 6 months
Indication for opioid
Types of indications for opioid prescriptions.
Measured: 6 months
Pharmacists opinions, attitudes, comfort level and actions
Survey
Measured: Before and after opioid quantity education and after 6 months
Patient experiences
Survey
Measured: After interaction with pharmacist.
Prescriber experiences
Survey
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start8 Sep 2020
- Primary completion21 Feb 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Safe Medication Practices Canada, North York General Hospital, The Royal Ottawa Mental Health Centre, Ontario Drug Policy Research Network
- Responsible party
- Sponsor
- Investigators
- Beth Sproule, PharmD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484610
- Sponsor's protocol ID
- 002-2019
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Appropriate Opioid Prescription Quantities for Acute Pain Treatment: A Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04484610
- Acronym / sponsor ID
- 002-2019
- Conditions
- Opioid Use, Acute Pain
- Keywords
- opioid, acute pain, pharmacist, pharmacy practice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Institute of Safe Medication Practices Canada, North York General Hospital, The Royal Ottawa Mental Health Centre, Ontario Drug Policy Research Network
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appropriate Opioid Quantities | Experimental | Drug: Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute PainPharmacists 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. |
| Usual Practice | No intervention | –Pharmacists in the comparison regions are not targeted for the practice change intervention (they are not invited nor provided access to the eLearning program). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute PainPharmacist eLearning modules, support tools and resources to promote assessing and dispensing appropriate opioid quantities for acute pain. | Drug | Appropriate Opioid Quantities |
Primary outcome
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.
8 secondary outcomes
Opioid Doses Dispensed
Time frame: After 6 months
Subsequent Opioid Dispensing
Time frame: 6 months
Opioid Quantity Changes per Pharmacy, Pharmacist and Prescriber
Time frame: 6 months
Prescription costs
Time frame: 6 months
Indication for opioid
Time frame: 6 months
Pharmacists opinions, attitudes, comfort level and actions
Time frame: Before and after opioid quantity education and after 6 months
Patient experiences
Time frame: After interaction with pharmacist.
Prescriber experiences
Time frame: After 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Sproule, PharmD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain in people with Opioid Use and Acute Pain, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Quantities Dispensed (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.