Impact Evaluation of the Therapeutic Initiative's Type 2 Diabetes in Older Adults Portrait and Therapeutics Letter
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 515
- 试验地点
- 2
- 主要终点
- Difference in change from baseline for mean number of patients with A1C < 7% taking a study drug between Group 1 and Group 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Registered for Portrait Online (the program's secure website).
排除标准
- •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.
结局指标
主要结局
Difference in change from baseline for mean number of patients with A1C < 7% taking a study drug between Group 1 and Group 2
时间窗: 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.
次要结局
- 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)
研究者
Colin Dormuth
Associate Professor
University of British Columbia