Cardiovascular Diseases, Diabetes
Conditions
Keywords
Digital Health, Remote Care Delivery, Team-based Care Model
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.
Interventions
DRUGSGLT2 inhibitor, GLP-1 RA
Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the Education-First intervention.
BEHAVIORALEducation-First
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.
Sponsors
Novo Nordisk A/S
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
27 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 27 - 79 years at the time of agreeing to participate in the program 2. Presence of type 2 diabetes (treated with metformin unless intolerant, may also be treated with DPP4i, sulfonylurea, pioglitazone, and/or basal insulin) 3. HbA1c 6.5-8.9%; AND 4. 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 5. Has seen a primary care provider within the Mass General Brigham network within the last year
Exclusion criteria
1. Type 1 diabetes 2. Currently or previously prescribed an SGLT2i or GLP1-RA 3. Taking any short-acting insulin 4. History of diabetic ketoacidosis 5. History of hypoglycemia requiring hospitalization 6. Frequent (more than two times in 1 week) episodes of symptomatic hypoglycemia with blood glucose \<70 mg/dL 7. eGFR below 15 ml/min/m2 8. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation, OR 9. Life expectancy less than 1 year or utilizing palliative care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time | Any time between 0-months (baseline) to 6-months following enrollment | Number of patients with prescriptions of SGLT2i or GLP1-RA at any time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 2-months |
| Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months | At 6-months following enrollment | Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months |
| Change in Short-form Patient Activation Measure (PAM) | From 0-months (baseline) to 6-months following enrollment | Change in Short-form Patient Activation Measure (PAM) The score is measured on a 0.0 - 4.0 point scale and indicates participants' relationships with and understanding of their health care. A higher value represents a better outcome. This measure indicates the change in participants' scores from the point of enrollment (0-months) to program completion (6-months). 0.0 - 1.0 (Disengaged & Overwhelmed) 1.1 - 2.0 (Becoming Aware But Still Struggling) 2.1 - 3.0 (Taking Action & Gaining Control) 3.1 - 4.0 (Maintaining Behaviors & Pushing Further) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (%) | From 0-months (baseline) to 6-months following enrollment | Change in body weight (%) |
| Change in Laboratory Measured HbA1c | From 0-months (baseline) to 6-months following enrollment | Change in laboratory measured HbA1c |
| Change in Body Weight (kg) | From 0-months (baseline) to 6-months following enrollment | Change in body weight (kg) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the Education-First intervention. | 116 |
| 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.
SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the Education-First intervention.
Education-First: 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. | 84 |
| Total | 200 |
Baseline characteristics
| Characteristic | Medication & Education-First | Education-First | Total |
|---|---|---|---|
| Age, Continuous | 66.6 Years STANDARD_DEVIATION 7.7 | 66.4 Years STANDARD_DEVIATION 7.5 | 66.5 Years STANDARD_DEVIATION 7.6 |
| Race/Ethnicity, Customized Asian | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Black | 14 Participants | 10 Participants | 24 Participants |
| Race/Ethnicity, Customized Declined | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 92 Participants | 64 Participants | 156 Participants |
| Sex: Female, Male Female | 42 Participants | 31 Participants | 73 Participants |
| Sex: Female, Male Male | 74 Participants | 53 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 69 | 0 / 37 |
| other Total, other adverse events | 36 / 69 | 14 / 37 |
| serious Total, serious adverse events | 2 / 69 | 0 / 37 |
Outcome results
Primary
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time
Number of patients with prescriptions of SGLT2i or GLP1-RA at any time
Time frame: Any time between 0-months (baseline) to 6-months following enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medication & Education-First | Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time | 81 Participants |
| Education-First | Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time | 47 Participants |
Secondary
Change in Short-form Patient Activation Measure (PAM)
Change in Short-form Patient Activation Measure (PAM) The score is measured on a 0.0 - 4.0 point scale and indicates participants' relationships with and understanding of their health care. A higher value represents a better outcome. This measure indicates the change in participants' scores from the point of enrollment (0-months) to program completion (6-months). 0.0 - 1.0 (Disengaged & Overwhelmed) 1.1 - 2.0 (Becoming Aware But Still Struggling) 2.1 - 3.0 (Taking Action & Gaining Control) 3.1 - 4.0 (Maintaining Behaviors & Pushing Further)
Time frame: From 0-months (baseline) to 6-months following enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication & Education-First | Change in Short-form Patient Activation Measure (PAM) | 0.3 score on a scale | Standard Deviation 0.9 |
| Education-First | Change in Short-form Patient Activation Measure (PAM) | 0.0 score on a scale | Standard Deviation 1.1 |
Secondary
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months
Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months
Time frame: 2-months following enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medication & Education-First | Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months | 62 Participants |
| Education-First | Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months | 7 Participants |
Secondary
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months
Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months
Time frame: At 6-months following enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medication & Education-First | Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months | 81 Participants |
| Education-First | Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months | 47 Participants |
Other Pre-specified
Change in Body Weight (%)
Change in body weight (%)
Time frame: From 0-months (baseline) to 6-months following enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication & Education-First | Change in Body Weight (%) | -2.5 % weight change | Standard Deviation 5.3 |
| Education-First | Change in Body Weight (%) | -2.0 % weight change | Standard Deviation 4.2 |
Other Pre-specified
Change in Body Weight (kg)
Change in body weight (kg)
Time frame: From 0-months (baseline) to 6-months following enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication & Education-First | Change in Body Weight (kg) | -4.2 kg | Standard Deviation 5 |
| Education-First | Change in Body Weight (kg) | -2.5 kg | Standard Deviation 2 |
Other Pre-specified
Change in Laboratory Measured HbA1c
Change in laboratory measured HbA1c
Time frame: From 0-months (baseline) to 6-months following enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication & Education-First | Change in Laboratory Measured HbA1c | -0.3 % change in HbA1c | Standard Deviation 0.8 |
| Education-First | Change in Laboratory Measured HbA1c | -0.3 % change in HbA1c | Standard Deviation 0.7 |