AzTrials
AzTrials

T2DM (Type 2 Diabetes Mellitus)NCT06976541

Utilization Study and Evaluation of Educational Intervention on HbA1c Testing

A study testing Portrait + Therapeutics Letter - EARLY and Portrait + Therapeutics Letter - DELAYED in people with T2DM (Type 2 Diabetes Mellitus) and Quality Improvement, run by University of British Columbia at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The aim of this randomized trial is to learn if educational materials and personalized prescribing Portraits change the frequency of ordering HbA1c tests by clinicians in British Columbia, Canada. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Portrait + Therapeutics Letter - EARLY and Portrait + Therapeutics Letter - DELAYED
Could I receive a placebo?
No, everyone receives an active treatment
How many people
968 participants
Where
1 siteCanada
Study dates
1 Jan 2023to 1 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Physicians and nurse practitioners:
  • Registered with the College of Physicians and Surgeons of B.C. or BC College of Nurses and Midwives as a nurse practitioner.
  • For physicians: defined as a General Practitioner or FP - Emergency Medicine according to the B.C. Ministry of Health's Medical Services Plan (MSP) with a licence status of private practice, temporary licence, salaried, or post graduate.
  • Had ≥100 patients with prescriptions filled at a community pharmacy in 2022.

Who cannot join

  • Not registered with the College of Physicians and Surgeons of B.C. or BC College of Nurses and Midwives as a nurse practitioner.
  • Physicians who 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 licence status of private practice, temporary licence, salaried, or post graduate.
  • Had fewer than 100 patients with prescriptions filled at a community pharmacy in 2023.

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

Other trials in Canada

About this study

Official title: Utilization Study and Impact Evaluation of the Therapeutic Initiative's Prescribing Portrait and Therapeutics Letter on HbA1c Testing

The aim of this randomized trial is to learn if educational materials and personalized prescribing Portraits change the frequency of ordering HbA1c tests by clinicians in British Columbia, Canada.

The main research question: To investigate the overall utilization patterns of HbA1c testing and evaluate the effectiveness of a personalized prescribing Portrait and educational materials to reduce over-utilization of HbA1c tests in diabetes management.

Participants are nurse practitioners and family physicians actively practicing in British Columbia. Participants are registered for the online prescribing Portrait program on the Therapeutics Initiative website where they can access their digital prescribing Portraits. Participants were randomized to receive educational materials on the topic of HbA1c testing either in an Early Group (Group 1 or Arm A) or in a Delayed Group (Group 2 or Arm B). Using administrative health data, the ordering of HbA1c tests by those in the Early Group will be compared with those in the Delayed Group to see if the materials influence the frequency of ordering HbA1c tests. Group 3 (Arm C) will be a control group for Groups 1 and 2 and include participants who receive no intervention.

Read the detailed description

Diabetes is a major health issue in Canada; about 30% of Canadians are diagnosed with diabetes or prediabetes, with an estimated healthcare system cost of $18.25 billion in 2024.

The glycated Hemoglobin (HbA1c) test is widely used for screening and monitoring diabetes and prediabetes. Canadian guidelines recommend a minimum of 3-month interval for re-testing in diabetes, and 6 months for patients who have reached stable glycemic control. HbA1c test reflects best the blood glucose level in the last 60 to 90 days. Testing too frequently creates unnecessary healthcare costs and burdens for patients and healthcare providers. Testing too infrequently is associated with inadequate glycemic control, and can lead to undiagnosed diabetes and diabetes complications.

Audit and feedback is an approach where individual prescribers receive feedback on their own prescribing or ordering of tests with the aim of improving their prescribing or ordering decisions. The Therapeutics Initiative research group does regular work in this area through the prescribing Portrait program, which aims to improve prescribing by providing audit and feedback and education to prescribers in British Columbia, Canada.

This study is a randomized trial testing the effectiveness of personalized prescribing Portraits and Therapeutics Letters to reduce the over utilization of HbA1c testing for patients with diabetes in the primary care setting in British Columbia. Patients with diabetes will be categorized in 3 groups: 1) diabetes; 2) pre-diabetes; 3) non-diabetic.

7776 active BC clinicians (family physicians and nurse practitioners) were randomly divided into 2 groups (n =3,888 in each group). At the time the Portraits were generated there were 968 people registered for the Portrait program and eligible to access this prescribing Portrait through the secure website (Group 1, n = 484; Group 2, n = 484). A third group of participants who are not registered with the Portrait program and will not have access to the intervention will be compared with Groups 1 and 2 in 2027.

On March 31, 2025 clinicians in Group 1 were notified by email that their prescribing Portraits and Therapeutics Letter were available for viewing in their Portrait accounts. Twelve months later, in March 2026, clinicians in Group 2 will receive this same notification and access to the same materials. The analysis will assess whether the materials led Group 1 clinicians to change how they order HbA1c tests for patients with diabetes.

The analysis will identify:

  • Baseline characteristics: Physicians and patients by study group (age, age groups, and sex). Patients with diabetes will be identified with a lookback of 12 months (from January 1, 2022) and will be divided into three categories: 1) diabetes; 2) prediabetes, or 3) non-diabetic.
  • Primary outcome: Difference in the change from baseline in the mean number of HbA1c tests per patient. Analysis will use a 2-sample t-test with an α = 0.05 to test whether the difference in the change from baseline is statistically significant.
  • Secondary outcome: Difference in the proportion of HbA1c tests ordered within 90 days of another test. The investigators will report relative risk and difference in proportions (with accompanying 95% confidence intervals).

Analysis will be conducted using secondary data from administrative databases from the BC Ministry of Health (under an Information Sharing Agreement). The data are patient level and include anonymized information about demographics, health costs, physician billing codes, prescriptions, outpatient records, and hospitalizations. The data do not include personally identifiable patient information.

Being tested
Portrait + Therapeutics Letter - EARLY, Portrait + Therapeutics Letter - DELAYED
Keywords
Randomized controlled trial, Type 2 diabetes, HbA1c testing, Quality Improvement, Prescribing Feedback
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Portrait + Therapeutics Letter - EARLYBehavioural

    In the context of audit and feedback interventions, the prescribing Portrait is a document produced by the Therapeutics Initiative that provides personalized prescribing feedback for clinicians in British Columbia. Portraits are used as a practice resource tool for reflection on prescribing or test-ordering patterns. Each Portrait topic provides data of individual prescriber's ordering of HbA1c tests within 90 days of a previous test along with evidence-based benchmarks or targets. Prescribers are also given access to a succinct review of the best available evidence on the topic and recommendations for future action in the Therapeutics Letter, a stand-alone publication that details the evidence for the recommended practice in a brief and practical manner. Therapeutics Letters include a systematic literature review on a clinical topic, and provide references for the data presented in the prescribing Portraits.

  • Portrait + Therapeutics Letter - DELAYEDBehavioural

    In the context of audit and feedback interventions, the prescribing Portrait is a document produced by the Therapeutics Initiative that provides personalized prescribing feedback for clinicians in British Columbia. Portraits are used as a practice resource tool for reflection on prescribing or test-ordering patterns. Each Portrait topic provides data of individual prescriber's ordering of HbA1c tests within 90 days of a previous test along with evidence-based benchmarks or targets. Prescribers are also given access to a succinct review of the best available evidence on the topic and recommendations for future action in the Therapeutics Letter, a stand-alone publication that details the evidence for the recommended practice in a brief and practical manner. Therapeutics Letters include a systematic literature review on a clinical topic, and provide references for the data presented in the prescribing Portraits.

Study groups in NCT06976541
Study groupRoleWhat they receive
Arm A (Group 1) - Early Portrait + LetterExperimentalThis arm gained access to the prescribing portrait and Therapeutics Letter on March 31, 2025. The materials were uploaded to the Portrait program online portal on this date, and recipients who are registrants to the Portrait program were sent an email notifying them of the new material available.
Receives: Behavioral: Portrait + Therapeutics Letter - EARLY
Arm B (Group 2) - Delayed controlExperimentalThis "delayed" control group will get access to the prescribing Portrait and Therapeutics Letter 12 months after Group 1 (March 31, 2026). The materials will be uploaded to the Portrait program online portal on this date, and recipients who are registrants to the Portrait program will be sent an email notifying them of the new material available.
Receives: Behavioral: Portrait + Therapeutics Letter - DELAYED
Arm C (Group 3) - Non-Portrait usersNo interventionThis group will not have access to the Portrait and Therapeutics Letter intervention because they are not registered with the Portrait program (i.e., non Portrait users).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intention-to-treat analysis

    The primary outcome is the difference in the change from baseline in the mean number of HbA1c tests ordered per patient.

    Measured: Assessed from 90 days before Jan 1, 2023 to 90 days after Dec 31, 2023 for Group 1. For Group 2, assessed from 90 days prior to Jan 1, 2024 to 90 days after Dec 31, 2024 (12 months + 180 days for both groups).

Secondary outcomes (1)
  1. Intention-to-treat analysis

    The secondary outcome is the difference in the proportion of HbA1c tests ordered within 90 days of another test.

    Measured: Assessed from 90 days before Jan 1, 2023 to 90 days after Dec 31, 2023 for Group 1. For Group 2, assessed from 90 days prior to Jan 1, 2024 to 90 days after Dec 31, 2024 (12 months + 180 days for both groups).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start1 Jan 2023
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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
The investigators randomized actively practicing family physicians and nurse practitioners into two groups, n=3888 in each group. Investigators then looked at who was registered to access online prescribing Portraits at the time of generating the early Portrait data. Group 1 (n=484) and Group 2 (n=484) for a total of 968 individuals. Group 1 received the intervention materials on March 31, 2025, while Group 2 received nothing (control group). Group 2 will receive the intervention materials in 12 months, in March 2026.
Masking
Single blind
Who is masked
Participant
Enrolment
968 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06976541
Sponsor's protocol ID
H25-01146
Status last verified
May 2025
First submitted
24 Apr 2025
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data access agreement for the Therapeutics Initiative does not permit sharing of IPD.

Questions about this trial

What is this clinical trial studying?

A study testing Portrait + Therapeutics Letter - EARLY and Portrait + Therapeutics Letter - DELAYED in people with T2DM (Type 2 Diabetes Mellitus) 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Intention-to-treat analysis (time frame: Assessed from 90 days before Jan 1, 2023 to 90 days after Dec 31, 2023 for Group 1. For Group 2, assessed from 90 days prior to Jan 1, 2024 to 90 days after Dec 31, 2024 (12 months + 180 days for both groups).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 May 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in