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

NCT04862858 | Unknown

• 1 other identifier: 1236
• Study Type: interventional
• Target: 4,197
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data

  Percentage of individuals with T2D \& ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products

  6-months

Secondary Outcomes (5)

• Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data

  12-months

• Percentage of individuals adherent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data

  6-months

• Percentage of individuals persistent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data

  6-months

• Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data

  6-months

• Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data

  12-months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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.

Other: Educational Intervention

Control

NO INTERVENTION

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

Interventions

Educational Intervention 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humana Inc.: lead
• Boehringer Ingelheim: collaborator
• Humana Healthcare Research, Inc.: collaborator

Study Sites (1)

Humana

Louisville, Kentucky, 40202, United States

Location

Related Publications (3)

• American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S111-S124. doi: 10.2337/dc21-S009.

  PMID: 33298420 BACKGROUND

• American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S125-S150. doi: 10.2337/dc21-S010.

  PMID: 33298421 BACKGROUND

• Das SR, Everett BM, Birtcher KK, Brown JM, Januzzi JL Jr, Kalyani RR, Kosiborod M, Magwire M, Morris PB, Neumiller JJ, Sperling LS. 2020 Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients With Type 2 Diabetes: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020 Sep 1;76(9):1117-1145. doi: 10.1016/j.jacc.2020.05.037. Epub 2020 Aug 5. No abstract available.

  PMID: 32771263 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Alexjandro Daviano, DN, DrPH

  Humana Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Consulting Lead

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 28, 2021
• Study Start: August 18, 2021
• Primary Completion: November 30, 2021
• Study Completion: August 16, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)