- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03411785
Evaluation of the Comprehensive Primary Care Plus (CPC+) Model
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria: None
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: CPC+ practices
This is the intervention group, and includes the practices that were selected and agreed to participate in the CPC+ model.
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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.
|
|
Sin intervención: Comparison practices
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Part A and Part B claims paid by Medicare in 2017
Periodo de tiempo: 12 months
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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
|
12 months
|
|
Total Part A and Part B claims paid by Medicare in 2018
Periodo de tiempo: 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
|
24 months
|
|
Total Part A and Part B claims paid by Medicare in 2019
Periodo de tiempo: 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
|
36 months
|
|
Total Part A and Part B claims paid by Medicare in 2020
Periodo de tiempo: 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
|
48 months
|
|
Total Part A and Part B claims paid by Medicare in 2021
Periodo de tiempo: 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
|
60 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Claims paid by Medicare in 2017 by type of service and service utilization
Periodo de tiempo: 12 months
|
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
|
12 months
|
|
Claims paid by Medicare in 2018 by type of service and service utilization
Periodo de tiempo: 24 months
|
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
|
24 months
|
|
Claims paid by Medicare in 2019 by type of service and service utilization
Periodo de tiempo: 36 months
|
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
|
36 months
|
|
Claims paid by Medicare in 2020 by type of service and service utilization
Periodo de tiempo: 48 months
|
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
|
48 months
|
|
Claims paid by Medicare in 2021 by type of service and service utilization
Periodo de tiempo: 60 months
|
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
|
60 months
|
|
Claims paid by Medicaid in 2017
Periodo de tiempo: 12 months
|
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
|
12 months
|
|
Claims paid by Medicaid in 2018
Periodo de tiempo: 24 months
|
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
|
24 months
|
|
Claims paid by Medicaid in 2019
Periodo de tiempo: 36 months
|
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
|
36 months
|
|
Claims paid by Medicaid in 2020
Periodo de tiempo: 48 months
|
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
|
48 months
|
|
Claims paid by Medicaid in 2021
Periodo de tiempo: 60 months
|
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
|
60 months
|
|
Quality-of-care process measures for 2017 based on claims data
Periodo de tiempo: 12 months
|
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)
|
12 months
|
|
Quality-of-care process measures for 2018 based on claims data
Periodo de tiempo: 24 months
|
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)
|
24 months
|
|
Quality-of-care process measures for 2019 based on claims data
Periodo de tiempo: 36 months
|
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)
|
36 months
|
|
Quality-of-care process measures for 2020 based on claims data
Periodo de tiempo: 48 months
|
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)
|
48 months
|
|
Quality-of-care process measures for 2021 based on claims data
Periodo de tiempo: 60 months
|
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)
|
60 months
|
|
Patient experience
Periodo de tiempo: 24 months
|
Self-reported measures of patient experience with primary care practitioner and practice
|
24 months
|
|
Patient experience
Periodo de tiempo: 36 months
|
Self-reported measures of patient experience with primary care practitioner and practice
|
36 months
|
|
Patient experience
Periodo de tiempo: 60 months
|
Self-reported measures of patient experience with primary care practitioner and practice
|
60 months
|
|
Practitioner and staff experience
Periodo de tiempo: 24 months
|
Self-reported measures of approaches to delivery of primary care and work experience at practice
|
24 months
|
|
Practitioner and staff experience
Periodo de tiempo: 48 months
|
Self-reported measures of approaches to delivery of primary care and work experience at practice
|
48 months
|
|
Practice's care delivery
Periodo de tiempo: 12 months
|
Self-reported measures of practice approaches to delivery of primary care
|
12 months
|
|
Practice's care delivery
Periodo de tiempo: 24 months
|
Self-reported measures of practice approaches to delivery of primary care
|
24 months
|
|
Practice's care delivery
Periodo de tiempo: 36 months
|
Self-reported measures of practice approaches to delivery of primary care
|
36 months
|
|
Practice's care delivery
Periodo de tiempo: 48 months
|
Self-reported measures of practice approaches to delivery of primary care
|
48 months
|
|
Practice's care delivery
Periodo de tiempo: 60 months
|
Self-reported measures of practice approaches to delivery of primary care
|
60 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Deborah Peikes, Ph.D., Mathematica Policy Research
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- CPCPlus2017
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Todas las condiciones
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University Hospital, Clermont-FerrandONAPS : Observatoire National de l'Activité Physique et de la SédentaritéTerminado
-
Union Hospital, Tongji Medical College, Huazhong...Reclutamiento
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Nantes University HospitalRetiradoCD22+ B-ALL recidivante/refractarioFrancia
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.Aún no reclutando
-
Institute of Hematology & Blood Diseases Hospital...Aún no reclutandoPh- Leucemia linfoblástica aguda (Ph-ALL)
-
Ruijin HospitalActivo, no reclutandoALL (leucemia linfoblástica aguda B) | Terapia de células CAR-TPorcelana
-
EdiGene (GuangZhou) Inc.The First Affiliated Hospital of Henan University of Science and TechnologyActivo, no reclutandoNeoplasia maligna de células B recidivante o refractaria (NHL/ALL)Porcelana
-
University of East AngliaTerminadoÁcido eicosapentaenoico | Fenómenos fisiológicos cardiovasculares | Óxido nítrico sintasa endotelial | Ácido docosahexaenoico (isómero All-Z)Reino Unido
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Institute of Hematology & Blood Diseases Hospital...ReclutamientoLeucemia linfoblástica aguda de células B (B-ALL) | Leucemia linfoblástica aguda ALL | Leucemia linfoblástica aguda infantilPorcelana, Hong Kong
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Singapore Eye Research InstituteDesconocidoLeucemia (tanto ALL como AML) | MDS-EB-1Singapur
Ensayos clínicos sobre CPC+ model
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Boston Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... y otros colaboradoresReclutamientoHemorragia | Bebés prematuros | Recién nacido | HidrocefaliaEstados Unidos
-
ivWatch, LLCAún no reclutandoInfiltración de Terapia IV Periférica
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Kepler University HospitalTerminado
-
University of PennsylvaniaMarch of DimesActivo, no reclutando
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Boston Children's HospitalThe Hospital for Sick Children; Yale University; CURE Children's Hospital, UgandaActivo, no reclutandoHidrocefaliaCanadá, Estados Unidos, Uganda
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Chase Pharmaceuticals Corporation, an affiliate...TerminadoEnfermedad de alzheimerEstados Unidos
-
Chase Pharmaceuticals Corporation, an affiliate...TerminadoDemencia del tipo AlzheimerEstados Unidos
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Axonics, Inc.Aún no reclutandoIncontinencia FecalEstados Unidos
-
Pyoeng Gyun ChoeTerminadoEnfermedades de la pielCorea, república de
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ivWatch, LLCAún no reclutandoInfiltración de Terapia IV PeriféricaEstados Unidos