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

Health Behavior Clinical Trial

— TAPERING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400384
• Other study ID #: CIHR 201506PHSI-337814-MB
• Status: Completed
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4255
• Est. completion date: December 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	Institut universitaire de gériatrie de Montréal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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