Viewing Study NCT05817253



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Last Modification Date: 2024-10-26 @ 2:56 PM
Study NCT ID: NCT05817253
Status: COMPLETED
Last Update Posted: 2023-04-18
First Post: 2023-02-09

Brief Title: Evaluation of Therapeutic Initiatives Cystitis Portrait and Therapeutics Letter
Sponsor: University of British Columbia
Organization: University of British Columbia

Study Overview

Official Title: Impact Evaluation of the Therapeutic Initiatives Uncomplicated Acute Cystitis Personalized Portrait and Therapeutics Letter
Status: COMPLETED
Status Verified Date: 2023-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 5000 British Columbian Family Practitioners FPs 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 FPs 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: 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 BC between September 2021 and March 2022

Approximately 5000 BC physicians were randomly divided into 3 arms each representing 33 that received the Portrait and Therapeutics Letter at different times Approximately 1691 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 LP 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 BC 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 prepost intervention A four-way comparison of numerators during the prepost periods between the early and delay groups will provide an odds ratio that approximates the relative risk

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None