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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Direct-to-consumer educational brochure
Sponsored by
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Inappropriate Dose of Drug Administered focused on measuring Deprescribing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut universitaire de gériatrie de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Direct-to-consumer educational brochure

Control wait list

Arm Description

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.

This arm will receive the intervention at the completion of the six-month follow-up period for the intervention group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 9, 2018
Last Updated
September 27, 2020
Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03400384
Brief Title
Trial Applying Policy to Eliminate or Reduce Inappropriate Narcotics in the General-population
Acronym
TAPERING
Official Title
Using Policy to Reduce Opioids by Educating and Empowering Patients With Chronic Non-cancer Pain: The TAPERING Randomised Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inappropriate Dose of Drug Administered, Pain, Chronic, Health Behavior
Keywords
Deprescribing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct-to-consumer educational brochure
Arm Type
Experimental
Arm Description
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.
Arm Title
Control wait list
Arm Type
No Intervention
Arm Description
This arm will receive the intervention at the completion of the six-month follow-up period for the intervention group.
Intervention Type
Other
Intervention Name(s)
Direct-to-consumer educational brochure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete cessation of opioids
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Dose reduction or therapeutic switch to an alternate analgesic
Description
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.
Time Frame
6 months
Title
The proportion of people achieving opioid doses below 90mg oral morphine equivalents.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cara Tannenbaum, MD, MSc
Organizational Affiliation
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de gériatrie de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3W1W5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31288859
Citation
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.
Results Reference
derived

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

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