- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03411785
Evaluation of the Comprehensive Primary Care Plus (CPC+) Model
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Total Part A and Part B claims paid by Medicare in 2017
Lasso di tempo: 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
|
12 months
|
Total Part A and Part B claims paid by Medicare in 2018
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Claims paid by Medicare in 2017 by type of service and service utilization
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 24 months
|
Self-reported measures of patient experience with primary care practitioner and practice
|
24 months
|
Patient experience
Lasso di tempo: 36 months
|
Self-reported measures of patient experience with primary care practitioner and practice
|
36 months
|
Patient experience
Lasso di tempo: 60 months
|
Self-reported measures of patient experience with primary care practitioner and practice
|
60 months
|
Practitioner and staff experience
Lasso di tempo: 24 months
|
Self-reported measures of approaches to delivery of primary care and work experience at practice
|
24 months
|
Practitioner and staff experience
Lasso di tempo: 48 months
|
Self-reported measures of approaches to delivery of primary care and work experience at practice
|
48 months
|
Practice's care delivery
Lasso di tempo: 12 months
|
Self-reported measures of practice approaches to delivery of primary care
|
12 months
|
Practice's care delivery
Lasso di tempo: 24 months
|
Self-reported measures of practice approaches to delivery of primary care
|
24 months
|
Practice's care delivery
Lasso di tempo: 36 months
|
Self-reported measures of practice approaches to delivery of primary care
|
36 months
|
Practice's care delivery
Lasso di tempo: 48 months
|
Self-reported measures of practice approaches to delivery of primary care
|
48 months
|
Practice's care delivery
Lasso di tempo: 60 months
|
Self-reported measures of practice approaches to delivery of primary care
|
60 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Direttore dello studio: Deborah Peikes, Ph.D., Mathematica Policy Research
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CPCPlus2017
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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