All ConditionsNCT03411785
Evaluation of the Comprehensive Primary Care Plus (CPC+) Model
A study testing CPC+ model in people with All Conditions, run by Mathematica Policy Research, Inc..
Trial summary
The Comprehensive Primary Care Plus (CPC+) Model, sponsored by the Centers for Medicare \& Medicaid Services (CMS), is a multipayer advanced primary care model. CPC+ aims to strengthen primary care by transforming how primary care practices deliver care, supported by regionally based multipayer payment reform… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- All Conditions
- What is being tested?
- CPC+ model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,326,531 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Medicare fee-for-service patients who receive the largest share of their evaluation and management visits from one of the study primary care practices.
- Practice managers, practitioners, and staff of the study primary care practices.
Who cannot join
- -
About this study
The Comprehensive Primary Care Plus (CPC+) Model, sponsored by the Centers for Medicare \& Medicaid Services (CMS), is a multipayer advanced primary care model. CPC+ aims to strengthen primary care by transforming how primary care practices deliver care, supported by regionally based multipayer payment reform, learning support, data feedback, and health information technology (health IT) support. The CPC+ evaluation will assess how CPC+ was implemented; how practices transformed care; and the effects on 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
This project is a large, seven-year mixed-methods evaluation of the Comprehensive Primary Care Plus (CPC+) Model, sponsored by the Centers for Medicare \& Medicaid Services (CMS). CPC+ aims to improve the delivery of primary care; patients' cost, service use, and quality of care; and the experiences of patients, practitioners, and staff. It aims to achieve these goals by helping practices transform across five key care delivery functions: (1) access and continuity, (2) care management, (3) comprehensiveness and coordination, (4) patient and caregiver engagement, and (5) planned care and population health.
The national model includes two rounds, each of which will last for five years. Round 1 will take place from January 2017 through December 2021 and Round 2 from January 2018 through December 2022. A total of 2,877 primary care practices are participating in Round 1. The number of Round 2 practices will not be confirmed until September 2017.
From practices that applied to participate, CMS selected those that provide primary care, met specific certified health information technology (health IT) requirements, and were already engaging in certain care delivery activities. The CPC+ model includes two transformation tracks with incrementally advanced care delivery requirements and payment options. Participating practices will receive financial payments from CMS, including a monthly care management fee and prospective performance-based incentive payment, on top of traditional payments. Some practices will also receive some payment that shifts away from fee-for-service. In addition, practices will receive payments from other participating payers, representing a large proportion of their total revenue. CPC+ practices will receive learning support, data feedback, and health IT support to promote transformation.
To estimate the effect of CPC+, the investigators will compare the outcomes over time for CPC+ practices with the outcomes over time for a group of comparison practices. The investigators selected the comparison practices by identifying practices that matched the CPC+ practices on key characteristics. The investigators expect to include up to 8,397 comparison practices in Round 1.
The investigators will estimate the impact of CPC+ on patient outcomes by tracking the patients who are attributed to a study practice based on receiving most of their evaluation and management care from that practice. The investigators expect to include approximately 5,326,531 attributed patients across the CPC+ and comparison practices in Round 1 (the number of attributed patients for the Round 2 practices is to be determined). Analyses of Medicare (and in some regions Medicaid) claims data for patients attributed to the CPC+ and comparison practices will be conducted to estimate impacts on Medicare expenditures, our primary outcome, and service use and quality of care.
The investigators will also estimate the impact of CPC+ on practice care delivery approaches, and patient, practitioner, and staff experience. The investigators will administer a practice survey to the practice managers of all the study practices to track changes in care delivery and practice characteristics. The investigators will measure patient experience through a survey administered to Medicare fee-for-service beneficiaries attributed to the study practices. Changes in work environment and practitioner and staff experience with CPC+ will be measured through a survey of primary care practitioners of the study practices and staff of the CPC+ practices. For the Round 1 practices, the investigators expect to administer 11,244 practice surveys, 20,000 patient surveys, 10,996 practitioner surveys, and 10,429 staff surveys, The sample sizes for surveys for the Round 2 practices are to be determined. Telephone interviews and site visits will be conducted with CPC+ payers; practitioners and staff in the practices, and, if relevant, the systems and medical groups that own them; patients; and other stakeholders to understand what was implemented, and barriers and facilitators to implementation and improved outcomes.
- Conditions
- All Conditions
- Being tested
- CPC+ model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPC+ modelOther
CPC+ practices receive a monthly care management fee and prospective performance-based incentive payment on top of traditional payments. Some practices will also receive some payment that shifts away from fee-for-service. In addition, CPC+ practices will receive learning and health IT support and data feedback to implement processes to meet care delivery requirements and achieve five primary care functions.
| Study group | Role | What they receive |
|---|---|---|
| CPC+ practices | Experimental | This is the intervention group, and includes the practices that were selected and agreed to participate in the CPC+ model. Receives: Other: CPC+ model |
| Comparison practices | No intervention | Comparison practices are the control group. This group includes practices not participating in the model that were matched to the CPC+ practices and whose outcomes will be compared to those of the CPC+ practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Part A and Part B claims paid by Medicare in 2017
Total claims paid by Medicare for for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 12 months
Total Part A and Part B claims paid by Medicare in 2018
Total claims paid by Medicare for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 24 months
Total Part A and Part B claims paid by Medicare in 2019
Total claims paid by Medicare for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 36 months
Total Part A and Part B claims paid by Medicare in 2020
Total claims paid by Medicare for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 48 months
Total Part A and Part B claims paid by Medicare in 2021
Total claims paid by Medicare for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 60 months
Secondary outcomes (25)
Claims paid by Medicare in 2017 by type of service and service utilization
Claims paid by Medicare for each of following: physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 12 months
Claims paid by Medicare in 2018 by type of service and service utilization
Claims paid by Medicare for each of following: physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 24 months
Claims paid by Medicare in 2019 by type of service and service utilization
Claims paid by Medicare for each of following: physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 36 months
Claims paid by Medicare in 2020 by type of service and service utilization
Claims paid by Medicare for each of following: physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 48 months
Claims paid by Medicare in 2021 by type of service and service utilization
Claims paid by Medicare for each of following: physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 60 months
Claims paid by Medicaid in 2017
Claims paid by Medicaid for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 12 months
Claims paid by Medicaid in 2018
Claims paid by Medicaid for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 24 months
Claims paid by Medicaid in 2019
Claims paid by Medicaid for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 36 months
Claims paid by Medicaid in 2020
Claims paid by Medicaid for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 48 months
Claims paid by Medicaid in 2021
Claims paid by Medicaid for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Measured: 60 months
Quality-of-care process measures for 2017 based on claims data
Quality-of-care outcome measures based on claims data (including 30-day hospital readmissions, rate of hospitalizations for ambulatory care sensitive admissions, and likelihood of emergency department revisits)
Measured: 12 months
Quality-of-care process measures for 2018 based on claims data
Quality-of-care outcome measures based on claims data (including 30-day hospital readmissions, rate of hospitalizations for ambulatory care sensitive admissions, and likelihood of emergency department revisits)
Measured: 24 months
Quality-of-care process measures for 2019 based on claims data
Quality-of-care outcome measures based on claims data (including 30-day hospital readmissions, rate of hospitalizations for ambulatory care sensitive admissions, and likelihood of emergency department revisits)
Measured: 36 months
Quality-of-care process measures for 2020 based on claims data
Quality-of-care outcome measures based on claims data (including 30-day hospital readmissions, rate of hospitalizations for ambulatory care sensitive admissions, and likelihood of emergency department revisits)
Measured: 48 months
Quality-of-care process measures for 2021 based on claims data
Quality-of-care outcome measures based on claims data (including 30-day hospital readmissions, rate of hospitalizations for ambulatory care sensitive admissions, and likelihood of emergency department revisits)
Measured: 60 months
Patient experience
Self-reported measures of patient experience with primary care practitioner and practice
Measured: 24 months
Patient experience
Self-reported measures of patient experience with primary care practitioner and practice
Measured: 36 months
Patient experience
Self-reported measures of patient experience with primary care practitioner and practice
Measured: 60 months
Practitioner and staff experience
Self-reported measures of approaches to delivery of primary care and work experience at practice
Measured: 24 months
Practitioner and staff experience
Self-reported measures of approaches to delivery of primary care and work experience at practice
Measured: 48 months
Practice's care delivery
Self-reported measures of practice approaches to delivery of primary care
Measured: 12 months
Practice's care delivery
Self-reported measures of practice approaches to delivery of primary care
Measured: 24 months
Practice's care delivery
Self-reported measures of practice approaches to delivery of primary care
Measured: 36 months
Practice's care delivery
Self-reported measures of practice approaches to delivery of primary care
Measured: 48 months
Practice's care delivery
Self-reported measures of practice approaches to delivery of primary care
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Jan 2017
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,326,531 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
- Deborah Peikes, Ph.D., Study director, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411785
- Sponsor's protocol ID
- CPCPlus2017
- Status last verified
- Jan 2018
- First submitted
- 5 Sep 2017
- Last updated
- 26 Jan 2018
- 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 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Comprehensive Primary Care Plus (CPC+) Model
- ClinicalTrials.gov ID
- NCT03411785
- Acronym / sponsor ID
- CPCPlus2017
- Conditions
- All Conditions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,326,531 participants (estimated)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 26 Jan 2018 (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 Comprehensive Primary Care Plus (CPC+) Model, sponsored by the Centers for Medicare \& Medicaid Services (CMS), is a multipayer advanced primary care model. CPC+ aims to strengthen primary care by transforming how primary care practices deliver care, supported by regionally based multipayer payment reform, learning support, data feedback, and health information technology (health IT) support. The CPC+ evaluation will assess how CPC+ was implemented; how practices transformed care; and the effects on 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
This project is a large, seven-year mixed-methods evaluation of the Comprehensive Primary Care Plus (CPC+) Model, sponsored by the Centers for Medicare \& Medicaid Services (CMS). CPC+ aims to improve the delivery of primary care; patients' cost, service use, and quality of care; and the experiences of patients, practitioners, and staff. It aims to achieve these goals by helping practices transform across five key care delivery functions: (1) access and continuity, (2) care management, (3) comprehensiveness and coordination, (4) patient and caregiver engagement, and (5) planned care and population health.
The national model includes two rounds, each of which will last for five years. Round 1 will take place from January 2017 through December 2021 and Round 2 from January 2018 through December 2022. A total of 2,877 primary care practices are participating in Round 1. The number of Round 2 practices will not be confirmed until September 2017.
From practices that applied to participate, CMS selected those that provide primary care, met specific certified health information technology (health IT) requirements, and were already engaging in certain care delivery activities. The CPC+ model includes two transformation tracks with incrementally advanced care delivery requirements and payment options. Participating practices will receive financial payments from CMS, including a monthly care management fee and prospective performance-based incentive payment, on top of traditional payments. Some practices will also receive some payment that shifts away from fee-for-service. In addition, practices will receive payments from other participating payers, representing a large proportion of their total revenue. CPC+ practices will receive learning support, data feedback, and health IT support to promote transformation.
To estimate the effect of CPC+, the investigators will compare the outcomes over time for CPC+ practices with the outcomes over time for a group of comparison practices. The investigators selected the comparison practices by identifying practices that matched the CPC+ practices on key characteristics. The investigators expect to include up to 8,397 comparison practices in Round 1.
The investigators will estimate the impact of CPC+ on patient outcomes by tracking the patients who are attributed to a study practice based on receiving most of their evaluation and management care from that practice. The investigators expect to include approximately 5,326,531 attributed patients across the CPC+ and comparison practices in Round 1 (the number of attributed patients for the Round 2 practices is to be determined). Analyses of Medicare (and in some regions Medicaid) claims data for patients attributed to the CPC+ and comparison practices will be conducted to estimate impacts on Medicare expenditures, our primary outcome, and service use and quality of care.
The investigators will also estimate the impact of CPC+ on practice care delivery approaches, and patient, practitioner, and staff experience. The investigators will administer a practice survey to the practice managers of all the study practices to track changes in care delivery and practice characteristics. The investigators will measure patient experience through a survey administered to Medicare fee-for-service beneficiaries attributed to the study practices. Changes in work environment and practitioner and staff experience with CPC+ will be measured through a survey of primary care practitioners of the study practices and staff of the CPC+ practices. For the Round 1 practices, the investigators expect to administer 11,244 practice surveys, 20,000 patient surveys, 10,996 practitioner surveys, and 10,429 staff surveys, The sample sizes for surveys for the Round 2 practices are to be determined. Telephone interviews and site visits will be conducted with CPC+ payers; practitioners and staff in the practices, and, if relevant, the systems and medical groups that own them; patients; and other stakeholders to understand what was implemented, and barriers and facilitators to implementation and improved outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPC+ practices | Experimental | Other: CPC+ modelThis is the intervention group, and includes the practices that were selected and agreed to participate in the CPC+ model. |
| Comparison practices | No intervention | –Comparison practices are the control group. This group includes practices not participating in the model that were matched to the CPC+ practices and whose outcomes will be compared to those of the CPC+ practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All Medicare fee-for-service patients who receive the largest share of their evaluation and management visits from one of the study primary care practices.
- Practice managers, practitioners, and staff of the study primary care practices.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| CPC+ modelCPC+ practices receive a monthly care management fee and prospective performance-based incentive payment on top of traditional payments. Some practices will also receive some payment that shifts away from fee-for-service. In addition, CPC+ practices will receive learning and health IT support and data feedback to implement processes to meet care delivery requirements and achieve five primary care functions. | Other | CPC+ practices |
Primary outcome
Total Part A and Part B claims paid by Medicare in 2017
Time frame: 12 months
Total claims paid by Medicare for for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Total Part A and Part B claims paid by Medicare in 2018
Time frame: 24 months
Total claims paid by Medicare for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Total Part A and Part B claims paid by Medicare in 2019
Time frame: 36 months
Total claims paid by Medicare for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Total Part A and Part B claims paid by Medicare in 2020
Time frame: 48 months
Total claims paid by Medicare for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
Total Part A and Part B claims paid by Medicare in 2021
Time frame: 60 months
Total claims paid by Medicare for physician services (primary care physician services, specialist services, and services provided by noninstitutional providers), inpatient hospital services, outpatient services, skilled nursing facility, durable medical equipment, hospice, and home health
25 secondary outcomes
Claims paid by Medicare in 2017 by type of service and service utilization
Time frame: 12 months
Claims paid by Medicare in 2018 by type of service and service utilization
Time frame: 24 months
Claims paid by Medicare in 2019 by type of service and service utilization
Time frame: 36 months
Claims paid by Medicare in 2020 by type of service and service utilization
Time frame: 48 months
Claims paid by Medicare in 2021 by type of service and service utilization
Time frame: 60 months
Claims paid by Medicaid in 2017
Time frame: 12 months
Claims paid by Medicaid in 2018
Time frame: 24 months
Claims paid by Medicaid in 2019
Time frame: 36 months
Claims paid by Medicaid in 2020
Time frame: 48 months
Claims paid by Medicaid in 2021
Time frame: 60 months
Quality-of-care process measures for 2017 based on claims data
Time frame: 12 months
Quality-of-care process measures for 2018 based on claims data
Time frame: 24 months
Quality-of-care process measures for 2019 based on claims data
Time frame: 36 months
Quality-of-care process measures for 2020 based on claims data
Time frame: 48 months
Quality-of-care process measures for 2021 based on claims data
Time frame: 60 months
Patient experience
Time frame: 24 months
Patient experience
Time frame: 36 months
Patient experience
Time frame: 60 months
Practitioner and staff experience
Time frame: 24 months
Practitioner and staff experience
Time frame: 48 months
Practice's care delivery
Time frame: 12 months
Practice's care delivery
Time frame: 24 months
Practice's care delivery
Time frame: 36 months
Practice's care delivery
Time frame: 48 months
Practice's care delivery
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- 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.
Deborah Peikes, Ph.D. study director
Mathematica Policy Research
Questions about this trial
What is this clinical trial studying?
A study testing CPC+ model in people with All Conditions, run by Mathematica Policy Research, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Total Part A and Part B claims paid by Medicare in 2017 (time frame: 12 months). The study lists 5 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 26 Jan 2018.