- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02320591
Evaluation of the Comprehensive Primary Care Initiative (CPC)
12. august 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
365076
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Jersey
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Princeton, New Jersey, Forente stater, 08540
- Mathematica Policy Research
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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for each Medicare beneficiary attributed to the practice, the practice received a monthly care management fee
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
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.
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Medicare expenditures
Tidsramme: 12 months
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average Medicare expenditures per month in Medicare fee-for-service
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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number of ER visits
Tidsramme: 12 months
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number of emergency room visits that did not result in a hospital admission
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12 months
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number of hospital admissions
Tidsramme: 12 months
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number of admissions to general acute short term hospitals during the followup period
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12 months
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30-day hospital readmission rate
Tidsramme: 30-days
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whether readmitted to the hospital within 30 days after discharge
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30-days
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hospital admission for ambulatory care sensitive condition
Tidsramme: 12 months
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whether admitted to hospital for a condition classified as being sensitive to the quality of ambulatory care received
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: deborah peikes, PhD, Mathematica Policy Research
- Studieleder: Timothy Day, MPP, Centers for Medicare & Medicaid Services
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- Dale 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2012
Primær fullføring (Faktiske)
1. juli 2017
Studiet fullført (Faktiske)
1. mai 2018
Datoer for studieregistrering
Først innsendt
15. desember 2014
Først innsendt som oppfylte QC-kriteriene
18. desember 2014
Først lagt ut (Anslag)
19. desember 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- HHSM-500-T0006
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
IPD-planbeskrivelse
not allowed; data belong to federal government (CMS)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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