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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

4197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-18

Study Completion Date

2022-08-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)

NCT03249506

Diabetes Mellitus, Type 2

COMPLETED

Action to Control Cardiovascular Risk in Diabetes (ACCORD)

NCT00000620

Atherosclerosis Cardiovascular Diseases Hypercholesterolemia +4 more

COMPLETED PHASE3

Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes

NCT05139914

Diabetes Mellitus, Type 2 Endothelial Dysfunction

RECRUITING PHASE4

Effect of SGLT2i on Cardiovascular Biomarkers in Patients With Type 2 Diabetes and CKD Stage 3b-4

NCT05033054

Kidney Disease, Chronic Diabetes

COMPLETED

Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D)

NCT02973477

Type2 Diabetes Cardiovascular Diseases

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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.

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type OTHER

The educational intervention will involve guideline-based treatment recommendation information for providers via fax/mail and phone and provide resources via mail and phone for patients to learn more about ways to reduce their cardiovascular risk.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational Intervention

The educational intervention will involve guideline-based treatment recommendation information for providers via fax/mail and phone and provide resources via mail and phone for patients to learn more about ways to reduce their cardiovascular risk.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No