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

NCT03400384 | Completed

• 1 other identifier: CIHR 201506PHSI-337814-MB
• Study Type: interventional
• Target: 4,255
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Deprescribing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dose reduction or therapeutic switch to an alternate analgesic

  6 months

• The proportion of people achieving opioid doses below 90mg oral morphine equivalents.

  6 months

Study Arms (2)

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.

Other: Direct-to-consumer educational brochure

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.

Interventions

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.

Direct-to-consumer educational brochure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Institut universitaire de gériatrie de Montréal

Montreal, Quebec, H3W1W5, Canada

Location

Related Publications (2)

• 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.

  PMID: 38809554 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.

  PMID: 31288859 DERIVED

MeSH Terms

Conditions

Chronic Pain; Health Behavior

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Cara Tannenbaum, MD, MSc

  Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the faculties of Medicine and Pharmacy, University of Montreal

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: July 17, 2018
• Primary Completion: April 30, 2019
• Study Completion: December 31, 2019
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

CA (1)