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

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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior; Pain, Chronic; Inappropriate Dose of Drug Administered
• Intervention / Treatment: Other: Direct-to-consumer educational brochure

• Study Type: Interventional
• Enrollment (Actual): 4255
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3W1W5
      • Institut universitaire de gériatrie de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct-to-consumer educational brochure; 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; 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.
No Intervention: Control wait list; 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?

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

Collaborators and Investigators

• Sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Cara Tannenbaum, MD, MSc, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Deprescribing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CIHR 201506PHSI-337814-MB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No