Diabetes Remote Intervention to improVe Use of Evidence-based Medications
Condition: Cardiovascular Diseases; Diabetes
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): SGLT2 inhibitor, GLP-1 RA; Education-First
Intervention type(s): Drug; Behavioral
Intervention description(s): Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.; 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.
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: Digital Health; Remote Care Delivery; Team-based Care Model