Impact Evaluation of the Therapeutic Initiative's Type 2 Diabetes in Older Adults Portrait and Therapeutics Letter

NCT06733805 | Active Not Recruiting

• 1 other identifier: H24-01347
• Study Type: interventional
• Target: 515
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Clinical Audit; Quality Improvement; T2DM (Type 2 Diabetes Mellitus)

Keywords

Randomized controlled trial; Type 2 Diabetes in older adults; Quality improvement; Prescribing feedback

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  9 months

Other Outcomes (1)

• Change from baseline in new starts of a study drug for patients with an A1C ≤ 7% between Group 1 who opened the Portrait and Group 2

  Up to 9 months

Study Arms (2)

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.

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.

Behavioral: Portrait + Therapeutics Letter

Interventions

Portrait + Therapeutics Letter BEHAVIORAL

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.

Group 1 - Early Portrait + Letter; Group 2 - Delayed Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Ministry of Health, British Columbia: collaborator

Study Sites (1)

Therapeutics Initiative - Dept of Anesthesiology, Pharmacology & Therapeutics, Faculty of Medicine, University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Colin Dormuth, ScD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 13, 2024
• Study Start: January 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)