Evaluation of Therapeutic Initiative's Cystitis Portrait and Therapeutics Letter

NCT ID: NCT05817253

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5073 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-23

Study Completion Date

2022-09-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a randomized trial testing the effectiveness of personalized prescribing Portraits and Therapeutics Letters on appropriate treatment for uncomplicated acute cystitis (urinary tract infection) in the primary care setting in the province of British Columbia (B.C.) between September, 2021 and March, 2022.

Approximately 5,000 B.C. physicians were randomly divided into 3 arms (each representing \~ 33%) that received the Portrait and Therapeutics Letter at different times. Approximately 1,691 physicians were randomized to each group. This "designed delay" will enable evaluation of the impact of Portraits and Therapeutics Letters on prescribing at an aggregate level across the province of British Columbia.

On the initial mailing (September 23, 2021), Early Letter + Portrait Arm received a early Portrait (P) + Letter (L), Delayed Control Arm received nothing, and Early Letter Arm received an Early Letter Only. On the delayed mailing (March 28, 2022), both Early Letter Arm and Delayed Control Arm received a delayed Portrait (P) + Letter (L).

Within the study and across these groups, there will be four comparisons as follows:

During the study period (Sept 23, 2021 to Mar 28, 2022):

i. Early Letter + Portrait Arm vs Delayed Control Arm (to test the impact of L+P combined) ii. Early Letter + Portrait Arm vs Early Letter Arm (to test the the added impact of P in physicians who received L) iii. Early Letter Arm vs Delayed Control Arm (to test the the impact of L)

During the study period (Sept 23, 2021 to Sept 28, 2022):

iv. Delayed Control Arm vs Early Letter Arm (to test the impact of repeated messaging)

The analysis will identify:

1. Baseline Characteristics: Physicians and Patients by Study Group. Age (mean, sd), age groups, sex, urban vs rural.
2. Trends: monthly prescribing line chart for all of B.C. of Nitrofurantoin, Ciprofloxacin, and Trimethoprim-sulfamethoxazole (TMP-SMX), from 1 year prior to first mailing (September 23, 2021) to the end of the delay period (September 2022). This will illustrate background trends in prescribing patterns.
3. Relative Risk: Prescribing in the early and delayed intervention groups will be compared 6 months pre/post intervention. A four-way comparison of numerators during the pre/post periods between the early and delay groups will provide an odds ratio that approximates the relative risk.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinical Audit Quality Improvement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early Letter + Portrait Arm

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.

Group Type EXPERIMENTAL

Portrait

Intervention Type BEHAVIORAL

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.

Therapeutics Letter

Intervention Type BEHAVIORAL

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 Arm

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.

Group Type EXPERIMENTAL

Portrait

Intervention Type BEHAVIORAL

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.

Therapeutics Letter

Intervention Type BEHAVIORAL

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.

Early Letter Arm

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

Group Type EXPERIMENTAL

Portrait

Intervention Type BEHAVIORAL

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.

Therapeutics Letter

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Portrait

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.

Intervention Type BEHAVIORAL

Therapeutics Letter

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, British Columbia

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Colin Dormuth

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Colin Dormuth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Vancouver, British Columbia, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39414374 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H22-01140

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevention of Cystitis.
NCT03744338 COMPLETED
Cranberry on Urinary Tract Infections
NCT01881165 WITHDRAWN PHASE4
Nutraceutical Efficacy for rUTI
NCT03395288 TERMINATED PHASE2/PHASE3