Medicare Expenditures, Quality of CareCPCNCT02320591
Evaluation of the Comprehensive Primary Care Initiative
A study testing care management fee, feedback reports and technical assistance in people with Medicare Expenditures, Quality of Care, run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medicare Expenditures, Quality of Care
- What is being tested?
- care management fee, feedback reports and technical assistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365,076 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2018
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Beneficiaries enrolled in a managed care plan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mathematica Policy Research
Princeton, New Jersey, 08540
About this study
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.
Read the 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.
- Conditions
- Medicare Expenditures, Quality of Care
- Being tested
- care management fee, feedback reports, technical assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care management feeOther
for each Medicare beneficiary attributed to the practice, the practice received a monthly care management fee
feedback reportsOther
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
technical assistanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Other: care management fee; Other: feedback reports; Other: technical assistance |
| Comparison group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Medicare expenditures
average Medicare expenditures per month in Medicare fee-for-service
Measured: 12 months
Secondary outcomes (4)
number of ER visits
number of emergency room visits that did not result in a hospital admission
Measured: 12 months
number of hospital admissions
number of admissions to general acute short term hospitals during the followup period
Measured: 12 months
30-day hospital readmission rate
whether readmitted to the hospital within 30 days after discharge
Measured: 30-days
hospital admission for ambulatory care sensitive condition
whether admitted to hospital for a condition classified as being sensitive to the quality of ambulatory care received
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJul 2012
- Primary completionJul 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medicare Expenditures, Quality of CareStudies 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
- 365,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Principal investigator, Randy Brown, Mathematica Policy Research, Inc.
- Investigators
- deborah peikes, PhD, Principal investigator, Mathematica Policy ResearchTimothy Day, MPP, Study director, Centers for Medicare & Medicaid Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320591
- Sponsor's protocol ID
- HHSM-500-T0006
- Acronym
- CPC
- Status last verified
- Aug 2019
- First submitted
- 15 Dec 2014
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: not allowed; data belong to federal government (CMS)
Publications
Peikes DN, Swankoski K, Hoag SD, Duda N, Coopersmith J, Taylor EF, Morrisson N, Palakal M, Holland J, Day TJ, Sessums LL. The Effects of a Primary Care Transformation Initiative on Primary Care Physician Burnout and Workplace Experience. J Gen Intern Med. 2019 Jan;34(1):49-57. doi: 10.1007/s11606-018-4545-0. Epub 2018 Jul 17.
PubMed 30019124Dale SB, Ghosh A, Peikes DN, Day TJ, Yoon FB, Taylor EF, Swankoski K, O'Malley AS, Conway PH, Rajkumar R, Press MJ, Sessums L, Brown R. Two-Year Costs and Quality in the Comprehensive Primary Care Initiative. N Engl J Med. 2016 Jun 16;374(24):2345-56. doi: 10.1056/NEJMsa1414953. Epub 2016 Apr 13.
PubMed 27074035
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Comprehensive Primary Care Initiative
- ClinicalTrials.gov ID
- NCT02320591
- Acronym / sponsor ID
- CPC / HHSM-500-T0006
- Conditions
- Medicare Expenditures, Quality of Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365,076 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Jul 2012 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 Dec 2014 (estimated)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: care management fee, Other: feedback reports, Other: technical assistancePractices 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. |
| Comparison group | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Beneficiaries enrolled in a managed care plan.
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 |
|---|---|---|
| care management feefor each Medicare beneficiary attributed to the practice, the practice received a monthly care management fee | Other | Treatment group |
| feedback reportsEach 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 | Treatment group |
| technical assistanceCPC 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. | Other | Treatment group |
Primary outcome
Medicare expenditures
Time frame: 12 months
average Medicare expenditures per month in Medicare fee-for-service
4 secondary outcomes
number of ER visits
Time frame: 12 months
number of hospital admissions
Time frame: 12 months
30-day hospital readmission rate
Time frame: 30-days
hospital admission for ambulatory care sensitive condition
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Derived from this study: PubMed 30019124Peikes DN, Swankoski K, Hoag SD, Duda N, Coopersmith J, Taylor EF, Morrisson N, Palakal M, Holland J, Day TJ, Sessums LL. The Effects of a Primary Care Transformation Initiative on Primary Care Physician Burnout and Workplace Experience. J Gen Intern Med. 2019 Jan;34(1):49-57. doi: 10.1007/s11606-018-4545-0. Epub 2018 Jul 17.
- Derived from this study: PubMed 27074035Dale SB, Ghosh A, Peikes DN, Day TJ, Yoon FB, Taylor EF, Swankoski K, O'Malley AS, Conway PH, Rajkumar R, Press MJ, Sessums L, Brown R. Two-Year Costs and Quality in the Comprehensive Primary Care Initiative. N Engl J Med. 2016 Jun 16;374(24):2345-56. doi: 10.1056/NEJMsa1414953. Epub 2016 Apr 13.
- Individual participant dataSharing planned: No. not allowed; data belong to federal government (CMS)
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, PhD principal investigator
Mathematica Policy Research
Timothy Day, MPP study director
Centers for Medicare & Medicaid Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care management fee, feedback reports and technical assistance in people with Medicare Expenditures, Quality of Care, 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.
Who may be eligible to take part?
The sponsor lists 1 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: finished, as of the sponsor's last update on 14 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medicare expenditures (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320591, which also lists 2 linked publications.
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 14 Aug 2019.