NCT05817253

Brief Summary

The goal of this randomized trial is to test the impact of mailing personalized prescribing Portraits (an audit and feedback tool) and Therapeutics Letters (a reference document) to physicians on first-line prescribing to patients with uncomplicated urinary tract infection (UTI) . The main question this study aims to answer is: • To what extent can personal prescribing feedback Portraits and Therapeutics Letters have an effect on how physicians prescribe antibiotics for uncomplicated UTI? Approximately 5,000 British Columbian Family Practitioners (FP's) have been randomly divided into three groups, and each group received the Portrait at different times. To help ascertain the possible impact of Portraits, pooled data on first-line prescribing for uncomplicated UTI by FP's who received the Portrait at an early time point (September 23, 2021) will be compared to that of those who received a Portrait at a delayed time point (March 28, 2022). Researchers will compare prescribing data from these groups to see if the prescribing Portraits have had a differential impact on prescribing of antibiotics for uncomplicated UTI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,073

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

February 9, 2023

Last Update Submit

April 4, 2023

Conditions

Keywords

Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Monthly prescribing of Nitrofurantoin

    The primary outcome is the proportion of uncomplicated acute cystitis episodes treated with nitrofurantoin.

    The study period for the primary analysis is the 185 day period after the early intervention, which is from September 24, 2021 to March 28, 2022..

Secondary Outcomes (1)

  • Monthly prescribing of ciprofloxacin, trimethoprim-sulfamethoxazole (TMP-SMX), and other antibiotics.

    The study period for the primary analysis is the 185 day period after the early intervention, which is from September 24, 2021 to March 28, 2022.

Study Arms (3)

Early Letter + Portrait Arm

EXPERIMENTAL

Early Letter + Portrait Arm received a Portrait + Therapeutics Letter with the initial mailing (September 23, 2021). At the delayed mailing (March 28, 2022), Early Letter + Portrait Arm received nothing.

Behavioral: PortraitBehavioral: Therapeutics Letter

Delayed Control Arm

EXPERIMENTAL

Delayed Control Arm received nothing with the initial mailing (on September 23, 2021). At the delayed mailing (March 28, 2022), Delayed Control Arm received a Portrait +Therapeutics Letter.

Behavioral: PortraitBehavioral: Therapeutics Letter

Early Letter Arm

EXPERIMENTAL

Early Letter Arm received a Therapeutics Letter only with the initial mailing (September 23, 2021). At the delayed mailing (March 28, 2022), Early Letter Arm received a Portrait + Therapeutics Letter

Behavioral: PortraitBehavioral: Therapeutics Letter

Interventions

PortraitBEHAVIORAL

In the context of audit and feedback interventions, Portrait is document produced by the physician organization 'Therapeutics Initiative' that provides personalized prescribing feedback for BC family physicians (FPs). Portraits are used as a practice resource tool for reflection on prescribing patterns. Each Portrait topic provides data of individual physician's prescribing practice, alongside the mean and median levels of their peers (other BC physicians), a succinct review of the best-available evidence on the topic, and recommendations for future action.

Delayed Control ArmEarly Letter + Portrait ArmEarly Letter Arm

The Therapeutics Letter is a standalone publication that details identified problematic therapeutic issues in a brief, simple and practical manner. Therapeutics letters include a systematic literature review on a clinical topic, and help provide reference for the data presented in the Portraits.

Delayed Control ArmEarly Letter + Portrait ArmEarly Letter Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Physicians who are:
  • i. Registered with the College of Physicians and Surgeons of B.C. (CPSBC) ii. Defined as a General Practitioner or Family Practice - Emergency Medicine according to the B.C. Ministry of Health's Medical Services Plan (MSP) with a license status of private practice, temporary license, salaried, or post graduate.
  • iii. Hold a valid mailing address in B.C according to the College of Physicians and Surgeons of British Columbia's public physician information.
  • iv. Had \>=100 prescriptions filled at a community pharmacy in 2020 according to PharmaNet claims.
  • v. Diagnosed \>= 1 eligible patient with Uncomplicated Acute Cystitis (UAC) in 2019 or 2020 (for delay group: 2020 to 2021

You may not qualify if:

  • Non-physicians, or physicians who:
  • i. Were not registered with the College of Physicians and Surgeons of B.C. (CPSBC) ii. Were not classified as a General Practitioner or Family Practice - Emergency Medicine according to the B.C. Ministry of Health's Medical Services Plan (MSP) with a license status of private practice, temporary license, salaried, or post graduate.
  • iii. Had an invalid mailing address in B.C according to the College of Physicians and Surgeons of British Columbia's public physician information.
  • iv. Had \<=100 prescriptions filled at a community pharmacy in 2020 according to PharmaNet claims.
  • v. Diagnosed \<= 1 eligible patient with Uncomplicated Acute Cystitis (UAC) in 2019 or 2020 (for delay group: 2020 to 2021

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therapeutics Initiative - Dept of Anesthesiology, Pharmacology & Therapeutics Faculty of Medicine University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (1)

  • Carney G, Maclure M, Patrick DM, Otte J, Ambasta A, Thompson W, Dormuth C. Pragmatic randomised trial assessing the impact of peer comparison and therapeutic recommendations, including repetition, on antibiotic prescribing patterns of family physicians across British Columbia for uncomplicated lower urinary tract infections. BMJ Qual Saf. 2025 Apr 17;34(5):295-304. doi: 10.1136/bmjqs-2024-017296.

Study Officials

  • Colin Dormuth, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Participants have been randomly divided into three groups which received the intervention at different times. Pooled data on the primary outcome (first-line prescribing for uncomplicated UTI) of those who received the intervention (mailed copy of personalized Portrait) early will be compared to that of those who received the delayed intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2023

First Posted

April 18, 2023

Study Start

September 23, 2021

Primary Completion

September 28, 2022

Study Completion

September 28, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations