Evaluation of Therapeutic Initiative's Cystitis Portrait and Therapeutics Letter

Quality Improvement Clinical Trial

Official title:

Impact Evaluation of the Therapeutic Initiative's Uncomplicated Acute Cystitis Personalized Portrait and Therapeutics Letter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05817253
• Other study ID #: H22-01140
• Status: Completed
• Phase: N/A
• Start date: September 23, 2021
• Est. completion date: September 28, 2022

Study information

• Verified date: April 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5073
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Clinical Audit
• Cystitis
• Quality Improvement

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Therapeutics Initiative - Dept of Anesthesiology, Pharmacology & Therapeutics Faculty of Medicine University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Ministry of Health, British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Monthly prescribing of ciprofloxacin, trimethoprim-sulfamethoxazole (TMP-SMX), and other antibiotics.	Secondary outcomes are the proportion of uncomplicated acute cystitis episodes treated with 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.