Evaluation of the Million Hearts CVD Risk Reduction Model

NCT04047147 | Unknown

• 1 other identifier: MPR50496
• Study Type: observational
• Target: 210,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

• Incidence of heart attacks and strokes among high risk

  Incidence of first-time heart attack and stroke among high CVD risk enrollees

  5 years

• Incidence of heart attacks and strokes among high and medium risk

  Incidence of first-time heart attack and stroke among high and medium CVD risk enrollees

  5 years

• CVD-related spending among high risk

  Medicare Part A and B spending (in dollars per person per quarter) for (1) heart attack/stroke hospitalizations and related post-acute care, and (2) heart attack/stroke emergency department visits among high CVD risk enrollees

  5 years

• CVD-related spending among high and medium risk

  Medicare Part A and B spending (in dollars per person per quarter) for (1) heart attack/stroke hospitalizations and related post-acute care, and (2) heart attack/stroke emergency department visits among high CVD risk enrollees

  5 years

Secondary Outcomes (13)

• Rate of all-cause mortality

  5 years

• Change in 10-year predicted CVD risk

  3 years

• Spending, without model payments

  5 years

• Spending, with model payments

  5 years

• Number of CVD-related hospitalizations

  5 year

Study Arms (2)

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.

Other: Enrollment in the Million Hearts CVD Risk Reduction Model

Enrollment in control provider organizations

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

Other: Enrollment in control provider organizations

Interventions

Enrollment in the Million Hearts CVD Risk Reduction Model 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 the Million Hearts CVD Risk Reduction Model

Enrollment in control provider organizations 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.

Enrollment in control provider organizations

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is a census of Medicare fee-for-service beneficiaries who were enrolled by providers (physicians, nurse practitioners, or physician assistants) in the intervention and control organizations. Providers enroll a beneficiary when they have an office visit with a patient and submit to CMS all of the CVD risk data needed to generate a risk score that is current as of that visit date. Providers submit these data to CMS via a registry-called the Million Hearts Model Data Registry-designed specifically for this purpose. Beneficiaries will be included in the study population if they meet the eligibility criteria. Following an intent-to-treat principle, we will keep beneficiaries in the sample for as long as they are alive and observable in Medicare FFS claims data (the primary source for study outcomes), whether or not they continue to receive clinical services from the participating organizations.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mathematica Policy Research, Inc.: lead
• Centers for Medicare and Medicaid Services: collaborator
• RAND: collaborator

Related Publications (1)

• 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.

  PMID: 37847273 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: August 6, 2019
• Study Start: January 3, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share