NCT06617533

Brief Summary

The Primary Care First (PCF) Model, sponsored by the Center for Medicare \& Medicaid Innovation (Innovation Center) of the Centers for Medicare \& Medicaid Services (CMS), is a multipayer advanced primary care model that aims to strengthen primary care by transforming how primary care practices deliver care. The PCF evaluation will assess how the PCF Model was implemented; how practices transformed care; and the effects on health care cost, service use, quality of care, and the experiences of patients, primary care practitioners, and staff. The evaluation will also identify facilitators and barriers to implementation and improved outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,000,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Jan 2021Dec 2026

Study Start

First participant enrolled

January 1, 2021

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

6 years

First QC Date

September 25, 2024

Last Update Submit

September 25, 2024

Conditions

Keywords

Primary Care FirstPCFprimary care delivery

Outcome Measures

Primary Outcomes (2)

  • Acute hospitalization rate

    Measured per 1,000 beneficiaries per year. Given the model payment structure rewards practices for decreasing hospitalizations, we hypothesize acute hospitalizations are the primary mechanism for reduced expenditures.

    5 years

  • Total Medicare Parts A and B expenditures

    Measured in dollars per beneficiary per month. Impacts on expenditures are central to CMS's decisions to expand an Innovation Center model and used to determine model PBA payments for practices.

    5 years

Secondary Outcomes (7)

  • Medical admissions

    5 years

  • Outpatient ED visits

    5 years

  • Primary-care-substitutable ED visits

    5 years

  • Proportion of inpatient discharges at the practice that had a 30-day all-cause unplanned readmission

    5 years

  • Proportion of inpatient discharges at the practice with unplanned 30-day acute care

    5 years

  • +2 more secondary outcomes

Study Arms (2)

Experimental: PCF practices

This is the intervention group, and includes the practices that were selected and agreed to participate in the PCF model.

Other: PCF model

No Intervention: Comparison practices

Comparison practices are the control group. This group includes practices not participating in the model that were matched to the PCF practices and whose outcomes will be compared to those of the PCF practices.

Interventions

PCF practices practices receive (1) a per-beneficiary-per-month prospective payment that depends on the average health of their attributed Medicare beneficiaries; (2) a Flat Visit Fee for primary care visits, subject to a geographic adjustment factor, and (3) a Performance-based Adjustment (PBA). The PBAs depend on practices' performance on several quality measures in addition to their performance in reducing beneficiaries' use of inpatient care or total cost of care, relative to national and regional benchmarks. Practices must meet a limited set of care delivery requirements and can use the PCF Model's flexible use of payments to invest in strategies that best suit their practices' unique patient population and resources. In return, practices take on limited financial risk in exchange for performance-based payments that reward participants that meet certain performance and quality benchmarks for selected outcomes.

Experimental: PCF practices

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of an intervention group comprised of Medicare fee-for-service beneficiaries assigned to PCF practices and a comparison group comprised of Medicare fee-for-service beneficiaries assigned to matched comparison practices.

You may qualify if:

  • Are ready to deliver advanced primary care (as measured by questions on the PCF application) when the model launches.
  • Located in 1 of 26 PCF regions
  • Have at least 125 attributed Medicare FFS beneficiaries
  • Have primary care services comprise at least 50 percent of billing, based on revenue, at model launch.
  • Start the model using 2015 certified electronic health record technology, enabling exchange of health information with other providers and systems and connection to regional health information exchange.
  • Be enrolled in both Medicare Parts A and B
  • Have Medicare as their primary payer.

You may not qualify if:

  • Have end stage renal disease
  • Currently enrolled in hospice care
  • Covered under a Medicare Advantage or other Medicare health plan
  • Currently long-term institutionalized
  • Currently incarcerated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mathematica Policy Research, Inc.

Princeton, New Jersey, 08543-2393, United States

Location

Study Officials

  • Laura Blue, PhD

    Mathematica Policy Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

January 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations