Diabetes Remote Intervention to improVe Use of Evidence-based Medications

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
DRIVE Program: Diabetes Remote Intervention to improVe Use of Evidence-based Medications

Conditions
-----------------
Diabetes, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: SGLT2 inhibitor, GLP-1 RA
* Behavioral: Education-First


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: One group of patients, upon randomization, will immediately begin participation in a remote, pharmacist-driven clinic that will initiate and titrate medications according to a standardized medical algorithm. The comparator group will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication & Education-First<br>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. | Drug: SGLT2 inhibitor, GLP-1 RA<br>* Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the Education-First intervention.<br>|
| Active Comparator: Education-First<br>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. | Drug: SGLT2 inhibitor, GLP-1 RA<br>* Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the Education-First intervention.<br>Behavioral: Education-First<br>* For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with prescriptions of SGLT2i or GLP1-RA at any time | Proportion of patients with prescriptions of SGLT2i or GLP1-RA at any time | From 0-months (baseline) to 6-months following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with prescriptions of SGLT2i or GLP1-RA by randomization arm | Proportion of patients with prescriptions of SGLT2i or GLP1-RA by randomization arm | From 0-months (baseline) to 6-months following enrollment | 
| Proportion of patients with prescriptions of SGLT2i or GLP1-RA at 2-months | Proportion of patients with prescriptions of SGLT2i or GLP1 RA at 2-months | 2-months following enrollment | 
| Proportion of patients with prescriptions of SGLT2i or GLP1-RA at 6-months | Proportion of patients with prescriptions of SGLT2i or GLP1-RA at 6-months | 6-months following enrollment | 
| Short-form Patient Activation Measure (PAM) | Short-form Patient Activation Measure (PAM) | From 0-months (baseline) to 6-months following enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digital Health, Remote Care Delivery, Team-based Care Model