Evaluation of the Million Hearts CVD Risk Reduction Model

NCT ID: NCT04047147

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 210000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2022-12-31

Brief Summary

The Million Hearts Cardiovascular Disease (CVD) Risk Reduction Model, run by the Centers for Medicare & Medicaid Services (CMS), seeks to improve cardiovascular care by providing incentives and supports for health care practitioners to engage in patient CVD risk calculation and population-level CVD risk management. CMS enrolled organizations throughout the United States, randomly assigning half to the intervention and half to a control group. This study is an evaluation of the model and will assess the model impacts on patient outcomes, changes in CVD care processes, and implementation challenges and successes.

Detailed Description

In January 2017, the Centers for Medicare & Medicaid Services (CMS) launched the Million Hearts Cardiovascular Disease (CVD) Risk Reduction model, designed to reduce heart attacks and strokes among Medicare fee for-service (FFS) beneficiaries. CMS is testing the Million Hearts CVD model over five years among more than 400 participating organizations, with half randomly assigned to the intervention and half to a control group. These organizations include primary care practices, specialty/multispecialty practices, health centers, and hospital outpatient departments. The intervention organizations are expected to:

• Risk stratify all of their eligible Medicare FFS beneficiaries, using the American College of Cardiology/American Heart Association (ACC/AHA) calculator to estimate each eligible beneficiary's risk of having a heart attack or stroke over the next 10 years. Beneficiaries are eligible if they are ages 40-79 as of enrollment in the program, have not had a heart attack or stroke, are enrolled in Medicare Part A and B, do not have end-stage renal disease, and are not receiving hospice benefits. Beneficiaries with a CVD risk exceeding 30 percent are considered high risk, whereas those with a risk from 15-30 percent are medium risk. All others are low risk.
• Provide cardiovascular care management to high-risk beneficiaries--which includes discussing with patients different options for reducing CVD risk, developing a care plan, and following up with patients at least twice a year (any mode) to assess and encourage progress on the care plan, and annual in-person visits to reassess risk and revise care plans.
• Collect and report clinical data to CMS via the Million Hearts Model Data Registry.
• Participate in learning system activities, including webinars and videoconferences, designed to spread effective strategies for implementing the model.

CMS supports the intervention organizations with payments for risk stratification, cardiovascular management, and risk reduction. Participating organizations receive payments for each eligible beneficiary they risk stratify. In the first model year, the cardiovascular management fees are fixed per beneficiary per month (PBPM) for each high-risk enrollee. In model year 2 and later, CMS is replacing the cardiovascular management fees with risk reduction payments that are scaled to the organization's performance in reducing 10-year predicted risk among their beneficiaries who were high-risk at initial enrollment. To support the model's evaluation, CMS is also paying control organizations to collect and report clinical data on their eligible Medicare FFS beneficiaries, but these organizations are not asked to calculate CVD risk scores or otherwise change their clinical care.

The primary goal of the investigators is to evaluate the impact of this model on first-time heart attacks and strokes and CVD-related spending among high CVD risk Medicare FFS beneficiaries, comparing beneficiaries in intervention practices with beneficiaries in control practices. Using Medicare Part A, B, and D administrative claims data, investigators also plan to evaluate the impact of the model on beneficiary mortality, CVD service utilization, and CVD-related medication use. The investigators will also use survey data from providers to identify changes in CVD-related knowledge, behaviors, and care delivery.

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Enrollment in the Million Hearts CVD Risk Reduction Model

Eligible Medicare fee-for-service (FFS) beneficiaries enrolled in provider organizations that were randomly assigned to participate in the Million Hearts CVD Risk Reduction Model intervention.

Enrollment in the Million Hearts CVD Risk Reduction Model

Intervention Type: OTHER

The intervention is at a provider organization level and all eligible beneficiaries enrolled by participants will be considered exposed. Intervention organizations receive payments to:

• Risk stratify eligible Medicare FFS beneficiaries
• Provide CVD care management to high-risk beneficiaries
• Collect and report clinical data to CMS via the Million Hearts Data Registry and participate in learning system activities

Participating organizations receive payments for each eligible beneficiary they risk stratify. In model year 1, the organizations receive a fixed payment per beneficiary per month to provide cardiovascular management. In model years 2-5, the organizations receive a risk reduction payment that is scaled based on reductions in 10-year predicted risk scores among their cohort of high-risk beneficiaries.

Enrollment in control provider organizations

Eligible Medicare fee-for-service (FFS) beneficiaries enrolled in provider organizations that were randomly assigned to the control group.

Enrollment in control provider organizations

Intervention Type: OTHER

Control organizations receive payments to collect and report clinical data on their eligible Medicare FFS beneficiaries, but are not asked to calculate CVD risk scores or otherwise change their clinical care.

Interventions

Enrollment in the Million Hearts CVD Risk Reduction Model

The intervention is at a provider organization level and all eligible beneficiaries enrolled by participants will be considered exposed. Intervention organizations receive payments to:

• Risk stratify eligible Medicare FFS beneficiaries
• Provide CVD care management to high-risk beneficiaries
• Collect and report clinical data to CMS via the Million Hearts Data Registry and participate in learning system activities

Participating organizations receive payments for each eligible beneficiary they risk stratify. In model year 1, the organizations receive a fixed payment per beneficiary per month to provide cardiovascular management. In model years 2-5, the organizations receive a risk reduction payment that is scaled based on reductions in 10-year predicted risk scores among their cohort of high-risk beneficiaries.

Intervention Type: OTHER

Enrollment in control provider organizations

Control organizations receive payments to collect and report clinical data on their eligible Medicare FFS beneficiaries, but are not asked to calculate CVD risk scores or otherwise change their clinical care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ages 40-79 as of enrollment in the program
• Enrolled in Medicare Part A and B
• Some analyses will include only those with a 10-year predicted CVD risk exceeding 30 percent (high risk). Others will include those with a 10-year predicted CVD risk exceeding 15 percent (high and medium risk).
• Some secondary analyses related to medication use will also be restricted to those enrolled in Medicare Part D

Exclusion Criteria

• Have had a heart or stroke previously
• Have end-stage renal disease
• Currently enrolled in hospice care

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Medicare and Medicaid Services

FED

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: collaborator

Mathematica Policy Research, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Blue L, Kranker K, Markovitz AR, Powell RE, Williams MV, Pu J, Magid DJ, McCall N, Steiner A, Stewart KA, Rollison JM, Markovich P, Peterson GG. Effects of the Million Hearts Model on Myocardial Infarctions, Strokes, and Medicare Spending: A Randomized Clinical Trial. JAMA. 2023 Oct 17;330(15):1437-1447. doi: 10.1001/jama.2023.19597.

Reference Type: DERIVED

PMID: 37847273 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MPR50496

Identifier Type: -

Identifier Source: org_study_id