Trial Applying Policy to Eliminate or Reduce Inappropriate Narcotics in the General-population

Study Overview
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Brief Summary
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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.

Official Title
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Using Policy to Reduce Opioids by Educating and Empowering Patients With Chronic Non-cancer Pain: The TAPERING Randomised Trial.

Conditions
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Inappropriate Dose of Drug Administered, Pain, Chronic, Health Behavior

Intervention / Treatment
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* Other: Direct-to-consumer educational brochure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults registered to receive pharmaceutical benefits in Manitoba, who are aged 18 years and over and who have received ≥90 days supply of opioids in the 6 months prior to the trial will be included. This will ensure chronic use and episodic use of opioids will be included. Exclusion Criteria: People receiving palliative care, people with cancer, and people who receive opioids in hospital. People with dementia (identified by having received a prescription for memantine or a cholinersterase inhibitor in the previous 12 months) will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct-to-consumer educational brochure<br>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. | Other: Direct-to-consumer educational brochure<br>* 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.<br>|
| No Intervention: Control wait list<br>This arm will receive the intervention at the completion of the six-month follow-up period for the intervention group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deprescribing