All ConditionsPCFNCT06617533
Evaluation of the Primary Care First Model
An observational study of All Conditions, run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- All Conditions
- What is being tested?
- PCF model
- How many people
- 25,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Practice Inclusion Criteria:
- 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.
Beneficiary Inclusion Criteria:
- Be enrolled in both Medicare Parts A and B
- Have Medicare as their primary payer.
Beneficiary Exclusion Criteria:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mathematica Policy Research, Inc.
Princeton, New Jersey, 08543-2393
About this study
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.
Read the detailed description
The Innovation Center launched the PCF Model in 2021. The PCF Model will test whether financial risk and performance-based payments for outcomes, including the acute hospitalization rate, will (1) reduce total Medicare fee-for-service (FFS) expenditures, (2) reduce use of health care services, and (3) preserve or enhance quality of care. The PCF Model will provide payments to participating practices through (i) a per beneficiary per month (PBPM) prospective payment and (2) a Flat Visit Fee, subject to a geographic adjustment factor. PCF practices may further be eligible for a quarterly Performance-based Adjustment (PBA) based on meeting certain performance and quality benchmarks.
The PCF Model builds on principles and experiences from past Innovation Center initiatives, including the Comprehensive Primary Care Initiative, Multi-Payer Advanced Primary Care Practice (MAPCP) demonstration, and Comprehensive Primary Care Plus (CPC+). CMS enrolled practices in the PCF Model in one of two cohorts. Cohort 1 practices participate from January 1, 2021, through December 31, 2025. Cohort 2 practices participate from January 1, 2022, through December 31, 2026. Cohort 2 includes many practices that participated in CPC+. CMS defines a primary care practice under the PCF Model as one or more primary care providers (physician, nurse practitioner, physician's assistant, or clinical nurse specialist) working within the same physical office location or practice site.
The primary goal of the evaluation is to determine whether the PCF Model preserves or enhances quality of care for Medicare FFS beneficiaries and lower expenditures for CMS. The general study design will compare beneficiaries in PCF practices with beneficiaries that receive care at matched comparison practices that aren't participating in PCF but are located in PCF regions. The study will rely on three types of data sources: (1) Medicare FFS claims and enrollment data, (2) payment data for the PCF Model and other CMS programs, and (3) area-level data sets with information on beneficiary and practice characteristics.. Using these data sources, investigators also plan to evaluate the impact of the model on health care service use and a set of secondary outcomes.
- Conditions
- All Conditions
- Being tested
- PCF model
- Keywords
- Primary Care First, PCF, primary care delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCF modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: PCF practices | This is the intervention group, and includes the practices that were selected and agreed to participate in the PCF model. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Secondary outcomes (7)
Medical admissions
Measured per 1,000 beneficiaries per year. Evaluations of similar primary care models (such as Comprehensive Primary Care Plus) found participating practices reduced medical admissions. We may expect to see impacts on this before impacts are evident on the broader acute hospitalization measure, which includes surgical admissions.
Measured: 5 years
Outpatient ED visits
Measured per 1,000 beneficiaries per year. Care delivery activities that seek to reduce acute hospitalizations may reduce ED utilization.
Measured: 5 years
Primary-care-substitutable ED visits
Measured per 1,000 beneficiaries per year. Care delivery activities that seek to reduce acute hospitalizations may reduce ED utilization; effects may be concentrated among primary-care-substitutable ED visits.
Measured: 5 years
Proportion of inpatient discharges at the practice that had a 30-day all-cause unplanned readmission
We may expect to see reductions in hospital readmissions through practices' focus on episodic care management.
Measured: 5 years
Proportion of inpatient discharges at the practice with unplanned 30-day acute care
We may expect to see reductions in unplanned acute care (including ED visits, observation stays, and unplanned readmissions) through practices' focus on episodic care management.
Measured: 5 years
Post-acute care (PAC) expenditures per PAC episode
Fewer acute hospitalizations may result in lower total PAC expenditures if savings in higher-cost institutional care (such as skilled nursing facility stays) offset potential cost increases in lower-cost home health expenditures.
Measured: 5 years
Inpatient expenditures
Measured in dollars per beneficiary per month. Fewer acute hospitalizations may result in lower inpatient expenditures, contributing to lower total Medicare FFS expenditures.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Sponsor
- Investigators
- Laura Blue, PhD, Principal investigator, Mathematica Policy Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617533
- Sponsor's protocol ID
- MPR50886
- Acronym
- PCF
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Primary Care First Model
- ClinicalTrials.gov ID
- NCT06617533
- Acronym / sponsor ID
- PCF / MPR50886
- Conditions
- All Conditions
- Keywords
- Primary Care First, PCF, primary care delivery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25,000,000 participants (estimated)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Innovation Center launched the PCF Model in 2021. The PCF Model will test whether financial risk and performance-based payments for outcomes, including the acute hospitalization rate, will (1) reduce total Medicare fee-for-service (FFS) expenditures, (2) reduce use of health care services, and (3) preserve or enhance quality of care. The PCF Model will provide payments to participating practices through (i) a per beneficiary per month (PBPM) prospective payment and (2) a Flat Visit Fee, subject to a geographic adjustment factor. PCF practices may further be eligible for a quarterly Performance-based Adjustment (PBA) based on meeting certain performance and quality benchmarks.
The PCF Model builds on principles and experiences from past Innovation Center initiatives, including the Comprehensive Primary Care Initiative, Multi-Payer Advanced Primary Care Practice (MAPCP) demonstration, and Comprehensive Primary Care Plus (CPC+). CMS enrolled practices in the PCF Model in one of two cohorts. Cohort 1 practices participate from January 1, 2021, through December 31, 2025. Cohort 2 practices participate from January 1, 2022, through December 31, 2026. Cohort 2 includes many practices that participated in CPC+. CMS defines a primary care practice under the PCF Model as one or more primary care providers (physician, nurse practitioner, physician's assistant, or clinical nurse specialist) working within the same physical office location or practice site.
The primary goal of the evaluation is to determine whether the PCF Model preserves or enhances quality of care for Medicare FFS beneficiaries and lower expenditures for CMS. The general study design will compare beneficiaries in PCF practices with beneficiaries that receive care at matched comparison practices that aren't participating in PCF but are located in PCF regions. The study will rely on three types of data sources: (1) Medicare FFS claims and enrollment data, (2) payment data for the PCF Model and other CMS programs, and (3) area-level data sets with information on beneficiary and practice characteristics.. Using these data sources, investigators also plan to evaluate the impact of the model on health care service use and a set of secondary outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: PCF practices | – | Other: PCF modelThis is the intervention group, and includes the practices that were selected and agreed to participate in the 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCF modelPCF 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. | Other | Experimental: PCF practices |
Primary outcome
Acute hospitalization rate
Time frame: 5 years
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.
Total Medicare Parts A and B expenditures
Time frame: 5 years
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.
7 secondary outcomes
Medical admissions
Time frame: 5 years
Outpatient ED visits
Time frame: 5 years
Primary-care-substitutable ED visits
Time frame: 5 years
Proportion of inpatient discharges at the practice that had a 30-day all-cause unplanned readmission
Time frame: 5 years
Proportion of inpatient discharges at the practice with unplanned 30-day acute care
Time frame: 5 years
Post-acute care (PAC) expenditures per PAC episode
Time frame: 5 years
Inpatient expenditures
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Blue, PhD principal investigator
Mathematica Policy Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Conditions, run by Mathematica Policy Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute hospitalization rate (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.