DRIVE Program: Diabetes Remote Intervention to improVe Use of Evidence-based Medications
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time
研究概览
简要总结
A randomized remote, implementation trial in the Mass General Brigham network was performed on 200 patients with T2D at high CV or kidney risk. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months.
详细描述
A randomized remote, implementation trial in the Mass General Brigham network performed on 200 patients with T2D at high CV or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP-1 RA were randomly assigned to 1) simultaneous patient education and medication initiation "simultaneous" arm or 2) 2-months of education followed by medication initiation "education-first" arm. A multi-disciplinary team provided education and prescribed GDMT using a treatment algorithm. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months. Secondary objectives included the primary outcome by randomization arm, prescribed therapy by 2 months, and patients taking prescribed therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 27 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 27 - 79 years at the time of agreeing to participate in the program
- •Presence of type 2 diabetes (treated with metformin unless intolerant, may also be treated with DPP4i, sulfonylurea, pioglitazone, and/or basal insulin)
- •HbA1c 6.5-8.9%; AND
- •At elevated cardiovascular and/or renal risk defined as any diagnosed ASCVD, estimated ASCVD risk >10%, congestive heart failure, non-alcoholic fatty liver disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, albuminuria above 300mg/g; and those aged 60 years or older with at least two of: active tobacco use, dyslipidemia (LDL-c above 160 mg/dL or 4.1 mmol/L, non-HDL-C above 190 mg/dL or 4.9 mmol/L, triglycerides above 175 mg/dL,) hypertension (2 systolic blood pressure values above 130 mmHg and/or 2 diastolic blood pressure values above 90 mmHg within 12 months,) or BMI above 30
- •Has seen a primary care provider within the Mass General Brigham network within the last year
排除标准
- •Type 1 diabetes
- •Currently or previously prescribed an SGLT2i or GLP1-RA
- •Taking any short-acting insulin
- •History of diabetic ketoacidosis
- •History of hypoglycemia requiring hospitalization
- •Frequent (more than two times in 1 week) episodes of symptomatic hypoglycemia with blood glucose <70 mg/dL
- •eGFR below 15 ml/min/m2
- •Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation, OR
- •Life expectancy less than 1 year or utilizing palliative care
研究组 & 干预措施
Medication & Education-First
Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.
干预措施: SGLT2 inhibitor, GLP-1 RA (Drug)
Education-First
Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.
干预措施: SGLT2 inhibitor, GLP-1 RA (Drug)
Education-First
Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.
干预措施: Education-First (Behavioral)
结局指标
主要结局
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time
时间窗: Any time between 0-months (baseline) to 6-months following enrollment
Number of patients with prescriptions of SGLT2i or GLP1-RA at any time
次要结局
- Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months(2-months following enrollment)
- Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months(At 6-months following enrollment)
- Change in Short-form Patient Activation Measure (PAM)(From 0-months (baseline) to 6-months following enrollment)
研究者
Benjamin M. Scirica, MD
Associate Professor, Harvard Medical School
Brigham and Women's Hospital