Evaluation of the Comprehensive Primary Care Initiative (CPC)

August 12, 2019 updated by: Randy Brown, Mathematica Policy Research, Inc.
This study assesses the effects of the Centers for Medicare and Medicaid Services' Comprehensive Primary Care (CPC) initiative on physician practices, practice staff, Medicare and Medicaid costs and service utilization, quality of care, and patient outcomes. CPC provides financial resources, timely feedback on key practice outcomes, and a learning network to support practice transformation to improve quality of care and lower costs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

CMS selected 7 regions (states or substate areas) to include in this study, based on commitment of other (ie, nonMedicare) payers in the area to provide financial resources to participating practices to support practice transformation to improve quality of care, reduce costs, and improve population health. 497 practices were selected from roughly 1000 applicants in the 7 regions to participate in the study. CMS pays participating practices a per member per month care management fee for each Medicare patient attributed to the practice. The practices also receive quarterly feedback on trends in their Medicare patients' use of hospital and emergency room services, Medicare expenditures, and patient outcomes from periodic surveys. Practices are expected to improve patient outcomes and lower Medicare costs per patient by using the additional resources to improve: risk-stratified care management, access and continuity of care, planned chronic and preventive care, patient and caregiver engagement, and coordination across the medical neighborhood. To remain in the study, practices must meet annual milestones for meaningful use of electronic health records and other practice features. The intervention period, which began in Fall 2012, will continue for 4 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365076

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Mathematica Policy Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medicare beneficiary attributed to CPC practice or to a matched comparison practice. Patients are attributed to the practice from which they received the most E&M visits during the 2-year period examined.

Exclusion Criteria:

  • Beneficiaries enrolled in a managed care plan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group
Practices assigned to the treatment group received per member per month care management fees for each Medicare beneficiary attributed to their practice. They also received quarterly feedback reports on their patients' average Medicare expenditures and use of hospital and emergency room services. Practices also had access to regional learning faculties for technical assistance with transformation activities and to share lessons across practices.
Other: care management fee
for each Medicare beneficiary attributed to the practice, the practice received a monthly care management fee
Other: feedback reports
Each participating practice received quarterly reports showing the practice's trend in key outcomes during the pre-intervention and intervention periods. The risk adjusted average Medicare expenditures of their patients were also shown in relation to all of the other CPC practices in their region, and to those with a similar average risk profile. Unadjusted hospitalization rates and emergency room visits were also plotted over time and compared to those of other CPC practices in the region
Other: technical assistance
CPC practices could ask for technical assistance on transformation activities from a regional learning faculty (RLF). The RLF also provided seminars and other learning activities, as well as provided a forum for participating practices to share lessons they had learned.
No Intervention: Comparison group
Within each of the 7 regions, this group is comprised of practices that were matched to the treatment practices on a wide range of baseline characteristics of the practices (including their service utilization patterns) and their patients. Comparison practices were selected from a pool of practices including those that applied to participate but were not selected, and practices serving nearby external comparison areas.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medicare expenditures
Time Frame: 12 months
average Medicare expenditures per month in Medicare fee-for-service
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number of ER visits
Time Frame: 12 months
number of emergency room visits that did not result in a hospital admission
12 months
number of hospital admissions
Time Frame: 12 months
number of admissions to general acute short term hospitals during the followup period
12 months
30-day hospital readmission rate
Time Frame: 30-days
whether readmitted to the hospital within 30 days after discharge
30-days
hospital admission for ambulatory care sensitive condition
Time Frame: 12 months
whether admitted to hospital for a condition classified as being sensitive to the quality of ambulatory care received
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mathematica Policy Research, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Medicare and Medicaid Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: deborah peikes, PhD, Mathematica Policy Research
  • Study Director: Timothy Day, MPP, Centers for Medicare & Medicaid Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HHSM-500-T0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

not allowed; data belong to federal government (CMS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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