Clinical AuditNCT06733805
Impact Evaluation of the Therapeutic Initiative's Type 2 Diabetes in Older Adults Portrait and Therapeutics Letter
A study testing Portrait + 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 learn if educational materials and personalized prescribing portraits change how clinicians in British Columbia (BC), Canada treat older adults with type 2 diabetes (T2DM). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Audit, Quality Improvement, T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- Portrait + Therapeutics Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to 15 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Registered with the College of Physicians and Surgeons of BC or BC College of Nurses and Midwives as a nurse practitioner.
- For physicians: defined as a General Practitioner or Family Physician - Emergency Medicine according to the BC Ministry of Health's Medical Services Plan with a license status of private practice, temporary license, salaried, or post graduate.
- Had ≥100 patients with prescriptions filled at a community pharmacy in 2022.
- Registered for Portrait Online (the program's secure website).
Who cannot join
- Not registered with the College of Physicians and Surgeons of BC 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 BC Ministry of Health's Medical Services Plan with a license status of private practice, temporary license, salaried, or post graduate.
- Had fewer than 100 patients with prescriptions filled at a community pharmacy in 2022.
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
The goal of this randomized trial is to learn if educational materials and personalized prescribing portraits change how clinicians in British Columbia (BC), Canada treat older adults with type 2 diabetes (T2DM). The main question the investigators aim to answer is:
- Did a personalized prescribing portrait and therapeutics letter lead to a change in the number of older adults prescribed sulfonylureas or insulin when they have glycated hemoglobin (A1C) levels below 7%, compared to usual care.
Study participants are nurse practitioners and family physicians actively practicing in BC, Canada. Participants registered on the project website, Portrait Online, to receive their digital prescribing portraits. Participants were randomized to either receive educational materials in the Early Group or in the Delayed Group. Using administrative health data, the prescribing of those in the Early Group will be compared to those in the Delayed Group to see if the materials influenced their prescribing.
Read the detailed description
Type 2 diabetes (T2DM) is common in older adults (65 years and older). Older adults are more likely to experience negative effects of medications used to treat T2DM, especially low blood sugar. Low blood sugar is dangerous for older adults and can lead to a higher risk of hospitalization. Medications such as insulins or sulfonylureas carry the highest risk of low blood sugar. Available evidence suggests that using insulin or sulfonylureas to treat T2DM to aggressive targets (glycated hemoglobin [A1C] less than 7%) does more harm than good. Therefore, insulin and sulfonylureas are not recommended for older adults with A1C less than 7%. Unfortunately, insulin and sulfonylurea use remains common among older adults living with T2DM.
Audit and feedback is an approach where individual prescribers receive feedback on their own prescribing (and may be compared to a benchmark) with the aim of improving their prescribing. This may be accompanied by education on how and why to improve. The investigators' research group does regular work in this area through the Portrait program, which aims to improve prescribing by providing audit and feedback and education to prescribers in British Columbia (BC), Canada.
This study is a randomized trial testing the effectiveness of personalized prescribing Portraits and Therapeutics Letters on prescribing of sulfonylureas and insulins for older patients with T2DM in the primary care setting in the Canadian province of BC.
6,814 active BC clinicians (family physicians and nurse practitioners) were randomly divided into 2 groups (n =3,407 in each group). At the time the Portraits were generated, there were 515 people registered for Portrait Online, the secure website through which clinicians are able to receive their confidential Portraits (Group 1, n = 259; Group 2, n = 256).
On January 15, 2024 Group 1 clinicians were notified by email that their prescribing Portraits and Therapeutics Letter were available for viewing in their Portrait Online accounts. Nine months later, on October 15, 2024, clinicians in Group 2 received this same notification and access to the same materials. The analysis will assess whether the materials led Group 1 clinicians to change how they prescribe sulfonylureas and insulins to older people with T2DM.
The analysis will include:
- Baseline characteristics of physicians and patients by study group
- Trends in monthly prescribing for all of BC of sulfonylureas and insulins from 1 year prior to release of the materials to the end of the study (January 15, 2023 to January 15, 2025). This will illustrate background trends in prescribing patterns.
- Difference in change from baseline for mean number of patients with A1C < 7% taking a sulfonylurea or insulin between Group 1 and Group 2.
- Proportion of patients with an A1C ≤ 7% who are newly started on a sulfonylurea or insulin by Group 1 prescribers compared to the proportion in the matched control group (Group 2).
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
- Keywords
- Randomized controlled trial, Type 2 Diabetes in older adults, 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 LetterBehavioural
In the context of audit and feedback interventions, Portrait is a document produced by the physician organization Therapeutics Initiative that provides personalized prescribing feedback for BC clinicians. Portraits are used as a practice resource tool for reflection on prescribing patterns. Each Portrait topic provides data of individual prescriber's prescribing practice, benchmarks or targets, a succinct review of the best-available evidence on the topic, and recommendations for future action.
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 provide reference for the data presented in the Portraits.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Early Portrait + Letter | Experimental | This group received the prescribing portrait and therapeutics letter on January 15, 2024. The materials were uploaded to the Portrait Online interface on this date, and recipients were sent an email notifying them of the new material available. Receives: Behavioral: Portrait + Therapeutics Letter |
| Group 2 - Delayed Control | Experimental | This group received the prescribing portrait and therapeutics letter on October 15, 2024 (9 months after Group 1 received the materials). The materials were uploaded to the Portrait Online interface on this date, and recipients were sent an email notifying them of the new material available. Receives: Behavioral: Portrait + Therapeutics Letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change from baseline for mean number of patients with A1C < 7% taking a study drug between Group 1 and Group 2
The primary outcome is the difference in the change from baseline in the mean number of patients with A1C ≤ 7% taking a sulfonylurea or insulin at 9-months after the early release of the Portrait and Therapeutics Letter (intention-to-treat analysis). The investigators will use a 2-sample t-test, with an alpha of 0.05 to test for statistical significance.
Measured: 9 months
Secondary outcomes (1)
Difference in change from baseline for mean number of patients with A1C < 7% taking a study drug between Group 1 who opened the Portrait and Group 2
The secondary outcome is the difference in the change from baseline in the mean number of patients with A1C ≤ 7% taking a sulfonylurea or insulin at 9-months after the early release of the Portrait for prescribers who opened the Portrait (per-protocol analysis). The investigators will use a 2-sample t-test, with an alpha of 0.05 to test for statistical significance.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start15 Jan 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- The investigators randomized actively practicing family physicians and nurse practitioners into two groups, n = 3,407 in each group. They then looked at who was registered for Portrait Online at the time of generating the early portrait data, and there were n=259 in Group 1, and n=256 in Group 2 for a total of 515 individuals. Group 1 received the intervention materials on January 15, 2024, while Group 2 received nothing (thus serving as the control group). Group 2 received the intervention materials nine months later, on October 15, 2024.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 515 participants (estimated)
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, ScD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733805
- Sponsor's protocol ID
- H24-01347
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study's data access does not permit sharing of individual participant data. Access to administrative data can be requested through the BC Ministry of Health.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the Therapeutic Initiative's Type 2 Diabetes in Older Adults Portrait and Therapeutics Letter
- ClinicalTrials.gov ID
- NCT06733805
- Acronym / sponsor ID
- H24-01347
- Keywords
- Randomized controlled trial, Type 2 Diabetes in older adults, Quality improvement, Prescribing feedback
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 515 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Ministry of Health, British Columbia
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 13 Dec 2024 (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 learn if educational materials and personalized prescribing portraits change how clinicians in British Columbia (BC), Canada treat older adults with type 2 diabetes (T2DM). The main question the investigators aim to answer is:
- Did a personalized prescribing portrait and therapeutics letter lead to a change in the number of older adults prescribed sulfonylureas or insulin when they have glycated hemoglobin (A1C) levels below 7%, compared to usual care.
Study participants are nurse practitioners and family physicians actively practicing in BC, Canada. Participants registered on the project website, Portrait Online, to receive their digital prescribing portraits. Participants were randomized to either receive educational materials in the Early Group or in the Delayed Group. Using administrative health data, the prescribing of those in the Early Group will be compared to those in the Delayed Group to see if the materials influenced their prescribing.
Detailed description
Type 2 diabetes (T2DM) is common in older adults (65 years and older). Older adults are more likely to experience negative effects of medications used to treat T2DM, especially low blood sugar. Low blood sugar is dangerous for older adults and can lead to a higher risk of hospitalization. Medications such as insulins or sulfonylureas carry the highest risk of low blood sugar. Available evidence suggests that using insulin or sulfonylureas to treat T2DM to aggressive targets (glycated hemoglobin [A1C] less than 7%) does more harm than good. Therefore, insulin and sulfonylureas are not recommended for older adults with A1C less than 7%. Unfortunately, insulin and sulfonylurea use remains common among older adults living with T2DM.
Audit and feedback is an approach where individual prescribers receive feedback on their own prescribing (and may be compared to a benchmark) with the aim of improving their prescribing. This may be accompanied by education on how and why to improve. The investigators' research group does regular work in this area through the Portrait program, which aims to improve prescribing by providing audit and feedback and education to prescribers in British Columbia (BC), Canada.
This study is a randomized trial testing the effectiveness of personalized prescribing Portraits and Therapeutics Letters on prescribing of sulfonylureas and insulins for older patients with T2DM in the primary care setting in the Canadian province of BC.
6,814 active BC clinicians (family physicians and nurse practitioners) were randomly divided into 2 groups (n =3,407 in each group). At the time the Portraits were generated, there were 515 people registered for Portrait Online, the secure website through which clinicians are able to receive their confidential Portraits (Group 1, n = 259; Group 2, n = 256).
On January 15, 2024 Group 1 clinicians were notified by email that their prescribing Portraits and Therapeutics Letter were available for viewing in their Portrait Online accounts. Nine months later, on October 15, 2024, clinicians in Group 2 received this same notification and access to the same materials. The analysis will assess whether the materials led Group 1 clinicians to change how they prescribe sulfonylureas and insulins to older people with T2DM.
The analysis will include:
- Baseline characteristics of physicians and patients by study group
- Trends in monthly prescribing for all of BC of sulfonylureas and insulins from 1 year prior to release of the materials to the end of the study (January 15, 2023 to January 15, 2025). This will illustrate background trends in prescribing patterns.
- Difference in change from baseline for mean number of patients with A1C < 7% taking a sulfonylurea or insulin between Group 1 and Group 2.
- Proportion of patients with an A1C ≤ 7% who are newly started on a sulfonylurea or insulin by Group 1 prescribers compared to the proportion in the matched control group (Group 2).
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The investigators randomized actively practicing family physicians and nurse practitioners into two groups, n = 3,407 in each group. They then looked at who was registered for Portrait Online at the time of generating the early portrait data, and there were n=259 in Group 1, and n=256 in Group 2 for a total of 515 individuals. Group 1 received the intervention materials on January 15, 2024, while Group 2 received nothing (thus serving as the control group). Group 2 received the intervention materials nine months later, on October 15, 2024.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Early Portrait + Letter | Experimental | Behavioral: Portrait + Therapeutics LetterThis group received the prescribing portrait and therapeutics letter on January 15, 2024. The materials were uploaded to the Portrait Online interface on this date, and recipients were sent an email notifying them of the new material available. |
| Group 2 - Delayed Control | Experimental | Behavioral: Portrait + Therapeutics LetterThis group received the prescribing portrait and therapeutics letter on October 15, 2024 (9 months after Group 1 received the materials). The materials were uploaded to the Portrait Online interface on this date, and recipients were sent an email notifying them of the new material available. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Registered with the College of Physicians and Surgeons of BC or BC College of Nurses and Midwives as a nurse practitioner.
- For physicians: defined as a General Practitioner or Family Physician - Emergency Medicine according to the BC Ministry of Health's Medical Services Plan with a license status of private practice, temporary license, salaried, or post graduate.
- Had ≥100 patients with prescriptions filled at a community pharmacy in 2022.
- Registered for Portrait Online (the program's secure website).
Key exclusion criteria (3 listed)
- Not registered with the College of Physicians and Surgeons of BC 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 BC Ministry of Health's Medical Services Plan with a license status of private practice, temporary license, salaried, or post graduate.
- Had fewer than 100 patients with prescriptions filled at a community pharmacy in 2022.
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 |
|---|---|---|
| Portrait + Therapeutics LetterIn the context of audit and feedback interventions, Portrait is a document produced by the physician organization Therapeutics Initiative that provides personalized prescribing feedback for BC clinicians. Portraits are used as a practice resource tool for reflection on prescribing patterns. Each Portrait topic provides data of individual prescriber's prescribing practice, benchmarks or targets, a succinct review of the best-available evidence on the topic, and recommendations for future action. 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 provide reference for the data presented in the Portraits. | Behavioural | Group 1 - Early Portrait + Letter, Group 2 - Delayed Control |
Primary outcome
Difference in change from baseline for mean number of patients with A1C < 7% taking a study drug between Group 1 and Group 2
Time frame: 9 months
The primary outcome is the difference in the change from baseline in the mean number of patients with A1C ≤ 7% taking a sulfonylurea or insulin at 9-months after the early release of the Portrait and Therapeutics Letter (intention-to-treat analysis). The investigators will use a 2-sample t-test, with an alpha of 0.05 to test for statistical significance.
1 secondary outcome
Difference in change from baseline for mean number of patients with A1C < 7% taking a study drug between Group 1 who opened the Portrait and Group 2
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No. This study's data access does not permit sharing of individual participant data. Access to administrative data can be requested through the BC Ministry of Health.
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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, ScD 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 + 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 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 13 Dec 2024. 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?
Difference in change from baseline for mean number of patients with A1C < 7% taking a study drug between Group 1 and Group 2 (time frame: 9 months). 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 13 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.