Clinical AuditNCT05817253
Evaluation of Therapeutic Initiative's Cystitis Portrait and Therapeutics Letter
A study testing Portrait and Therapeutics Letter in people with Clinical Audit and Quality Improvement, run by University of British Columbia at 1 site in Canada.
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) . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Audit, Quality Improvement
- What is being tested?
- Portrait and Therapeutics Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,073 participants
- Where
- 1 siteCanada
- Study dates
- 23 Sep 2021to 28 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physicians who are:
- 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.
- Hold a valid mailing address in B.C according to the College of Physicians and Surgeons of British Columbia's public physician information.
- Had >=100 prescriptions filled at a community pharmacy in 2020 according to PharmaNet claims.
- Diagnosed >= 1 eligible patient with Uncomplicated Acute Cystitis (UAC) in 2019 or 2020 (for delay group: 2020 to 2021
Who cannot join
- Non-physicians, or physicians who:
- 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.
- Had an invalid mailing address in B.C according to the College of Physicians and Surgeons of British Columbia's public physician information.
- Had <=100 prescriptions filled at a community pharmacy in 2020 according to PharmaNet claims.
- Diagnosed <= 1 eligible patient with Uncomplicated Acute Cystitis (UAC) in 2019 or 2020 (for delay group: 2020 to 2021
Trial locations and contacts
1 site in 1 country.
Canada1 site
Therapeutics Initiative - Dept of Anesthesiology, Pharmacology & Therapeutics Faculty of Medicine University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Impact Evaluation of the Therapeutic Initiative's Uncomplicated Acute Cystitis Personalized Portrait and Therapeutics Letter
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:
Read more
- 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.
Read the 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 (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):
- 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:
- Baseline Characteristics: Physicians and Patients by Study Group. Age (mean, sd), age groups, sex, urban vs rural.
- 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.
- 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
- Clinical Audit, Quality Improvement
- Being tested
- Portrait, Therapeutics Letter
- Keywords
- Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PortraitBehavioural
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 LetterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Portrait; Behavioral: 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. Receives: Behavioral: Portrait; Behavioral: 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 Receives: Behavioral: Portrait; Behavioral: Therapeutics Letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly prescribing of Nitrofurantoin
The primary outcome is the proportion of uncomplicated acute cystitis episodes treated with nitrofurantoin.
Measured: 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.
Secondary outcomes are the proportion of uncomplicated acute cystitis episodes treated with ciprofloxacin, trimethoprim-sulfamethoxazole (TMP-SMX), and other antibiotics.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start23 Sep 2021
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical AuditStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, British Columbia
- Responsible party
- Principal investigator, Colin Dormuth, University of British Columbia
- Investigators
- Colin Dormuth, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817253
- Sponsor's protocol ID
- H22-01140
- Status last verified
- Apr 2023
- First submitted
- 9 Feb 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39414374
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the Therapeutic Initiative's Uncomplicated Acute Cystitis Personalized Portrait and Therapeutics Letter
- ClinicalTrials.gov ID
- NCT05817253
- Acronym / sponsor ID
- H22-01140
- Conditions
- Clinical Audit, Quality Improvement
- Keywords
- Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,073 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Ministry of Health, British Columbia
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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):
- 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:
- Baseline Characteristics: Physicians and Patients by Study Group. Age (mean, sd), age groups, sex, urban vs rural.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Letter + Portrait Arm | Experimental | Behavioral: Portrait, Behavioral: Therapeutics LetterEarly 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. |
| Delayed Control Arm | Experimental | Behavioral: Portrait, Behavioral: Therapeutics LetterDelayed 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. |
| Early Letter Arm | Experimental | Behavioral: Portrait, Behavioral: Therapeutics LetterEarly 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Hold a valid mailing address in B.C according to the College of Physicians and Surgeons of British Columbia's public physician information.
- Had >=100 prescriptions filled at a community pharmacy in 2020 according to PharmaNet claims.
- Diagnosed >= 1 eligible patient with Uncomplicated Acute Cystitis (UAC) in 2019 or 2020 (for delay group: 2020 to 2021
Key exclusion criteria (5 listed)
- 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.
- Had an invalid mailing address in B.C according to the College of Physicians and Surgeons of British Columbia's public physician information.
- Had <=100 prescriptions filled at a community pharmacy in 2020 according to PharmaNet claims.
- Diagnosed <= 1 eligible patient with Uncomplicated Acute Cystitis (UAC) in 2019 or 2020 (for delay group: 2020 to 2021
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PortraitIn 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. | Behavioural | Delayed Control Arm, Early Letter + Portrait Arm, Early Letter Arm |
| Therapeutics LetterThe 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. | Behavioural | Delayed Control Arm, Early Letter + Portrait Arm, Early Letter Arm |
Primary outcome
Monthly prescribing of Nitrofurantoin
Time frame: 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..
The primary outcome is the proportion of uncomplicated acute cystitis episodes treated with nitrofurantoin.
1 secondary outcome
Monthly prescribing of ciprofloxacin, trimethoprim-sulfamethoxazole (TMP-SMX), and other antibiotics.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39414374Carney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Dormuth, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portrait and Therapeutics Letter in people with Clinical Audit and Quality Improvement, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly prescribing of Nitrofurantoin (time frame: 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..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05817253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.