Educational Intervention to Increase Select Guideline-recommended Cardioprotective Medications in Patients With Diabetes

Humana

Status: Unknown

Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Other: Educational Intervention

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04862858

1236

Details and patient eligibility

About

This is an educational outreach to patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) and their primary care and specialist providers to improve use of guideline-recommended treatments, specifically sodium-glucose cotransporter 2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.

Full description

Patients with type 2 diabetes mellitus, a history of atherosclerotic cardiovascular disease, without use of select guideline-recommended medications in the previous year will be identified from administrative claims. Primary care providers will be identified, randomly selected and randomized to the intervention arm or control arm. All eligible patients for that provider will be included. The patient's specialist providers (cardiologist and/or endocrinologist, as applicable) will be identified and contacted. The intervention will include a multi-faceted strategy to support providers in the care of their patients by sharing recent guideline-based treatment recommendations and provide patients with information regarding ways to reduce their cardiovascular risk. Outreach will occur for all patients and providers randomized for the intervention - there will be no active enrollment or recruitment.

Enrollment: 4,197 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient

• Patients with T2DM defined as ≥2 outpatient diagnoses of T2DM in any position on separate days; OR ≥1 inpatient diagnosis T2DM in any position; OR ≥1 outpatient diagnosis in any position AND ≥1 medication claim for T2DM
• ≥1 diagnosis code for ASCVD (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification
• Enrolled in a Humana Medicare Advantage Prescription Drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date
• Age 18-85 years at time of identification
• Patients residing in Kentucky (KY), West Virginia (WV), Pennsylvania (PA), and 6 counties in south New Jersey (NJ) (Burlington, Camden, Cumberland, Gloucester, Mercer, Salem) (United States)

Provider

• Primary care providers of the identified patients

Exclusion criteria

Patients

• ≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure
• Any hospice or long-term care residence
• ≥1 code for pregnancy/childbirth
• Patients with any use of SGLT2i or GLP-1 RA medications in the pre-identification period
• Patients without an attributed primary care provider
• Patients on do not contact lists
• Patients without valid addresses and telephone numbers
• Patients with ≥1 diagnosis for type 1 diabetes pre-identification

Primary care providers

• Providers on do not contact lists
• Providers without valid fax/mailing address and phone number
• Providers with <3 or >50 eligible patients

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,197 participants in 2 patient groups

Intervention

Active Comparator group

Description:

The educational outreach intervention will entail a multi-faced strategy to provide patients resources to learn more about reducing their risk for heart disease and supporting providers in the care of their patients by sharing recent guideline-recommended treatments for these high-risk individuals.

Treatment:

Other: Educational Intervention

Control

No Intervention group

Description:

Patients and primary care providers randomly selected and assigned to the control arm will not receive any of the educational outreach communications.