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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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To assess the effectiveness of a government-led population-based opioid intervention on discontinuation of opioid medication in community-dwelling adults with chronic non-cancer pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct-to-consumer educational brochure | Experimental | The intervention arm will be mailed an evidence-based, theory-driven direct-to-consumer educational brochure, highlighting the potential benefits and harms of opioids when used to treat chronic non-cancer pain. |
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| Control wait list | No Intervention | This arm will receive the intervention at the completion of the six-month follow-up period for the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct-to-consumer educational brochure | Other | The intervention arm will be mailed an evidence-based, theory-driven direct-to-consumer educational brochure, highlighting the potential benefits and harms of opioids when used to treat chronic non-cancer pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete cessation of opioids | Provincial prescription insurance claims will be used to measure whether or not opioids are dispensed to community-dwelling adults randomized to either the intervention or control groups between baseline and 6-month follow up. Prescription data contain information on all dispensed prescriptions including drug name, dispensing date, dosage, drug form, the quantity of the drug dispensed, and the license number of the physician who wrote the prescription. Discontinuation of an opioid will be defined as the lack of a prescription claim for at least 60 days. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose reduction or therapeutic switch to an alternate analgesic | The magnitude and direction of dose changes will be assessed for people who do not achieve the primary endpoint of complete cessation. New pharmacy dispensing of a prescription for a lower strength, or supply of a reduced quantity of tablets/patches will be considered in the dose reduction calculation. Where substitution to an alternative opioid occurs, opioid doses will be converted to "oral morphine equivalents" to determine the magnitude and direction of the change. A therapeutic switch will be indicated by a new dispensing for an alternative medication class. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cara Tannenbaum, MD, MSc | Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de gériatrie de Montréal | Montreal | Quebec | H3W1W5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38809554 | Derived | Turner JP, Halme AS, Caetano P, Langford A, Tannenbaum C. Government Direct-to-Consumer Education to Reduce Prescription Opioid Use: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2413698. doi: 10.1001/jamanetworkopen.2024.13698. | |
| 31288859 | Derived | Turner JP, Caetano P, Tannenbaum C. Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial. Trials. 2019 Jul 9;20(1):412. doi: 10.1186/s13063-019-3508-z. |
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| 6 months |
| The proportion of people achieving opioid doses below 90mg oral morphine equivalents. | All opioids will be converted to an oral morphine equivalent dose. The proportion of patients who are prescribed <90mg of oral morphine equivalent at the end of the 6-month follow up will be compared to baseline. | 6 months |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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