Condition category
Signs and Symptoms
Date applied
30/03/2020
Date assigned
10/04/2020
Last edited
29/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Prescription opioid addiction due to unsafe prescribing is associated with considerable harm and economic cost. If left untreated, the mortality rate is high. Individualized prescribing portraits are letters that aim to identify unsafe prescribing and motivate an individual physician to do something about it. They have been shown to reduce injudicious prescribing for patients with chronic diseases, but they have never been tested in people being initiated on opioids for pain. Among opioid-naïve patients being initiated on opioids for pain, previous work conducted by members of this team highlighted a dearth of valid ways to identify at-risk patients, the importance of opioid-sparing approaches to evidence-based pain management, and significant beneficial effects of individualized prescribing portraits on new prescribing for both chronic and acute conditions. The aim of this study is to determine whether a ‘complex’ intervention that includes i) individualized prescribing portraits, ii) online training on safer prescribing, and iii) academic detailing (by the British Columbia Centre on Substance Use), can reduce the proportion of new opioid prescriptions for people with pain. The study is being conducted with family physicians in British Columbia and will involve distributing individualized prescribing portrait to all family physicians, optional academic detailing and training of prescribers. The study is being conducted by experts responsible for research, planning and delivery of addiction treatment/primary care in Canada.

Who can participate?
Primary care prescribers in British Columbia. The researchers are not asking physicians to participate. They will mail portraits to as many as 6500 primary care prescribers. The prescribers who receive the Portrait are not regarded as participants in research because they have the option of ignoring any or all ‘Letters’, and do not submit any data or do anything that might be called “participation.” In addition, prescribers are offered a low-barrier chance to “opt-out” of receiving Portrait, at any time using phone, fax, email or an online portal for withdrawal. The recipients of portraits can decide instantaneously to stop reading at any time.

What does the study involve?
Participants are randomly allocated to one of two groups. An early group receives the intervention first and a delayed group receives the intervention 6 months later. The intervention consists of four steps. Step 1: The analyst with the research group develops prescribing portraits. A pdf file of all individual portraits is produced with only a code number on each portrait. The Portrait will have no identifying information on it, only a code number will be printed also on the sealed envelope with no identifying information. The Portrait ID code number on the sealed envelope is used to match the Portrait with the addressed envelope. There is no collection of information from the prescribers associated with the mailing of the Portraits. Step 2: The analyst provides the pdf of coded Portraits to the printer (British Columbia, BC, Mail) via SFTP, who automatically stuffs them into envelopes labelled with the code number. On the envelope is printed a diagram showing how the researchers preserve data privacy. Step 3: Once the envelopes are sealed, the team then provides BC Mail with an address list that matches the Portrait ID code # on the exterior of the privacy envelope with the address of the prescriber. A small number of prescribers have requested to not receive the Portraits, these addresses have been flagged and they will not receive any Portrait materials. Step 4: Prescribers open the de-identified coded envelope and look at their portrait. The covering letter gives contact information for requests to be excluded as well as links for online training on safer prescribing an invitation to academic detailing session in their community. The prescriber decides which training they complete, if any. There will be a qualitative assessment of the complex-intervention experience among a purposive sample of end-users.

What are the possible benefits and risks of participating?
The benefits include safer, more effective and more cost-effective prescribing for patients, and more informed prescribers. There are no risks. Occasionally a prescriber might feel uncomfortable about receiving a portrait of his/her prescribing even when no one else has seen it. Should that level of discomfort remain, they may opt-out of the program at any time.

Where is the study run from?
Therapeutics Initiative, University of British Columbia (Canada)

When is the study starting and how long is it expected to run for?
October 2020 to October 2023

Who is funding the study?
British Columbia Ministry of Health - F17-04802 Therapeutics Initiative – Shared cost arrangement (Canada)

Who is the main contact?
1. Dr Rita McCracken
rita.mccracken@ti.ubc.ca
2. Ian Cooper
ian.cooper@ti.ubc.ca

Trial website

https://www.ti.ubc.ca/portrait/

Contact information

Type

Scientific

Primary contact

Dr Rita McCracken

ORCID ID

https://orcid.org/0000-0002-2962-0364

Contact details

2176 Health Sciences Mall
Therapeutics Initiative
University of British Columbia
Vancouver
V6T 1Z3
Canada
+1 (0)778 996 6894
rita.mccracken@ubc.ca

Type

Scientific

Additional contact

Dr Malcolm Maclure

ORCID ID

Contact details

2176 Health Sciences Mall
Therapeutics Initiative
University of British Columbia
Vancouver
V6T 1Z3
Canada
+1 (0)604 875 4111 X 23025
malcolm.maclure@ubc.ca

Type

Scientific

Additional contact

Mr Ian Cooper

ORCID ID

Contact details

Research Project Coordinator
Portrait Project - Therapeutics Initiative
UBC
Department of Anesthesiology
Therapeutics & Pharmacology
305 - 2176 Health Sciences Mall
Vancouver
V6T1Z3
Canada
+1 (0)604 822 4887
ian.cooper@ti.ubc.ca

Type

Scientific

Additional contact

Dr Jan Klimas

ORCID ID

http://orcid.org/0000-0002-5179-0052

Contact details

Portrait Project - Therapeutics Initiative
UBC
Department of Anesthesiology
Therapeutics & Pharmacology
305 - 2176 Health Sciences Mall
Vancouver
V6T 1Z3
Canada
+1 (0)604 822 4887
jklimas@mail.ubc.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Optimizing strategies to reduce inappropriate initiation of prescription opioid analgesics to opioid-naïve patients in primary care

Acronym

SPARING

Study hypothesis

This study is taking place to examine the rates of newly prescribed opioids by primary care prescribers in British Columbia prior to, and following, an educational intervention using both an audit and feedback tool, and an online training course. It is hypothesized that the educational intervention will decrease the rate of opioid initiation to opioid-naive patients.

Ethics approval

Approved 06/03/2020, Clinical Research Ethics Board at the University of British Columbia (Clinical Research Ethics Board, Room 210, 828 West 10th Avenue, Vancouver, BC, V5Z 1L8, Canada; +1 (0)604 875 4149; ors@ors.ubc.ca), ref: H20-00656

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Opioid-sparing pain management

Intervention

Intervention 1: Complex intervention (composed of academic detailing or an online training course, a prescribing portrait).
Intervention 2: Usual care followed by delayed complex intervention.

The research component of this project is the impact evaluation to determine the impact of personalized prescribing feedback Portraits on primary care prescriber initiation of opioid prescription. This will entail: a) a sophisticated data analysis to produce a more accurate elucidation of the effect of anonymous Portraits on prescribing, b) paired matching of communities in the mailing list with randomization into Early and Delayed communities (by a third-party statistician, using random sequence generator software), and c) statistical analyses comparing Early versus Delayed groups. An early group receives the intervention first and a delayed group receives the intervention six months later. The researchers hypothesize that the personalized prescribing-portrait intervention will be associated with a decrease in the number of opioid prescriptions initiated in ‘opioid naïve’ patients. They will extract administrative health data to determine the total number of opioid prescription initiations per prescriber in ‘opioid naïve’ patients. The Ministry of Health has given the Therapeutics Initiative’s team permission to use its databases for the Portrait project. The purpose of dividing prescribers into an early and delayed group is to provide evidence of the impact of receiving the portrait and educational materials on prescribing. Optional safer-prescribing educational opportunities will be provided by the British Columbia Centre on Substance Use. Analysing trends in aggregate data from the two groups will demonstrate impact (separate from other factors in the prescribing environment).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The number of new opioid prescriptions to opioid-naïve patients in the last 12 months, calculated based on the administrative claims databases of the Ministry of Health in the last 6 months at the 6-month follow up.

Secondary outcome measures

1. Length of opioid prescriptions measured by counting the number of days of uninterupted prescribing from initiation to cessation at baseline and 6-month follow-up
2. Average dose of opioid prescriptions measured by summing up the dose from all prescriptions and dividing the sum of all doses by the number of prescriptions at baseline and 6-month follow-up
3. Intervention experience measured using semi-structured focus groups among a purposive sample of end-users at 6-month follow-up

Overall trial start date

01/10/2020

Overall trial end date

01/10/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Physicians currently treating patients (defined as having written at least 25 prescriptions, for any drug, in the preceding 12 months)
2. Have prescribed at least one opioid during the study period

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

6001

Participant exclusion criteria

1. Currently residing outside of BC
2. Unavailable contact information (e.g., deceased, retired)
3. Not currently practicing (are retired), or who have not prescribed at least one opioid during the study period

Recruitment start date

04/01/2021

Recruitment end date

02/01/2023

Locations

Countries of recruitment

Canada

Trial participating centre

Therapeutics Initiative, University of British Columbia
2176 Health Sciences Mall
Vancouver
V6T 1Z3
Canada

Sponsor information

Organisation

Therapeutics Initiative, University of British Columbia

Sponsor details

2176 Health Sciences Mall
Vancouver
V6T 1Z3
Canada
+1 (0)604 822 0700
portrait@ti.ubc.ca

Sponsor type

Government

Website

https://www.ti.ubc.ca/portrait/

Funders

Funder type

Government

Funder name

British Columbia Ministry of Health - F17-04802 Therapeutics Initiative – Shared cost arrangement

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study protocol:
Optimizing strategies to reduce inappropriate initiation of prescription opioid analgesics to opioid naïve patients in primary care: Study design and rationale

Development and pilot of intervention:
Development and process evaluation of a complex intervention to reduce initiation of opioid analgesics to opioid naïve patients in primary care in a Canadian setting

Baseline data:
Incidence of initiation of opioid analgesics to opioid naïve patients in primary care in a Canadian setting

Qualitative:
Patient experience of complex intervention to reduce initiation of opioid analgesics to opioid naïve patients in primary care in a Canadian setting: qualitative study
Physician/practice nurse experience of complex intervention to reduce initiation of opioid analgesics to opioid naïve patients in primary care in a Canadian setting: qualitative study

Main results:
Optimizing strategies to reduce inappropriate initiation of prescription opioid analgesics to opioid naïve patients in primary care: immediate and sustained outcomes from a Quality Improvement initiative

IPD sharing statement
The authors do not have permission to share data from this study. The administrative health data used for this project will be stored on a remote server at the British Columbia Ministry of Health with a high level of security, including encrypted identifiers. Access to the data will be password protected. All data will be encrypted and password protected. Only files that are de-identified will be used by the PI, and CO-I’s and analysts, for analysis. The impact evaluation analyses will also be done in the Ministry's secure data environment, and only aggregate data (tables with cell sizes 5+) will be exported, to prevent re-identification of data. The de-identified impact evaluation analyses will be held in the Ministry’s secure data environment until 2023 for the purposes of publication.

Intention to publish date

23/03/2025

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/04/2020: ORCID ID added. 14/04/2020: A scientific contact has been added. 07/04/2020: Trial's existence confirmed by the University of British Columbia Office of Research Ethics.