Comprehensive Care Physician: Integrated Inpatient and Outpatient Care for Patients at High Risk of Hospitalization (CCP)
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|ClinicalTrials.gov Identifier: NCT01929005|
Recruitment Status : Recruiting
First Posted : August 27, 2013
Last Update Posted : January 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Medicare Patients High Risk of Hospitalizations||Other: Comprehensive Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Integrated Inpatient/Outpatient Care for Patients at High Risk of Hospitalization|
|Actual Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
No Intervention: Standard of Care
If patients are randomized to standard of care, they are not assigned to a Comprehensive Care Physician. They are asked to continue receiving their care as they normally would.
Experimental: Comprehensive Care
Patients randomized to the Comprehensive Care group are assigned to a Comprehensive Care physician and are asked to see their assigned CCP for their primary care. The patients will receive their care by the CCP in the outpatient clinic and also if they were to be hospitalized.
Other: Comprehensive Care
Patients will receive comprehensive medical care from their CCP in clinic and the hospital. For most patients, the ambulatory care provided by the CCP will be in our onsite medicine clinic, but for some patients with subspecialty needs the CCP may be a specialist who will care for the patient in a nearby ambulatory setting (e.g., nursing home, dialysis facility). The CCPs will also supervise the nurses, pharmacists, social workers, and others who are part of the multi-disciplinary care team. Daytime inpatient care will be provided by CCPs in conjunction with our inpatient advanced practice nurses (APNs). These APNs now work with our hospitalists, so they are experienced providing hospital care.
- Patient Satisfaction [ Time Frame: Every 3 months after patient enrollment up to 3 years ]patient satisfaction measured by Consumer Assessment of Health Plans (CAHPs) instrument
- Total Cost of Care [ Time Frame: Cumulative costs after enrollment up to 3 years ]Total cost of care will be measured using Medicare claims data obtained from RESDAC to examine all care that charged to Medicare, including use of acute care hospitals, physician services, SNF, home health, hospice, etc., and Part D. We will also seek to link to data from Illinois Medicaid for our dual eligibles.
- Patient outcomes [ Time Frame: Every 3 months after enrollment up to 3 years ]Patient outcomes will be measured by quarterly assessment by phone of health status using the SF-12, limitations of activities of daily living (ADLs) and instrumental ADLs (IADLs) and patient satisfaction (e.g., Consumer Assessment of Health Plans (CAHPs) instrument).
- Care utilization [ Time Frame: Cumulative utilization from patient enrollment up to 3 years ]Following Donabedian's framework, we will first assess the extent to which care is structured with integrity to the CCP model using a primary measure of what fraction of a patient's clinic and hospital encounters are provided by their CCP. Care utilization will be measured using Medicare claims data obtained from RESDAC to examine all care that charged to Medicare, including use of acute care hospitals, physician services, SNF, home health, hospice, etc., and Part D. We are experienced working with these raw claim files for research. We will also link to data from Illinois Medicaid for our dual eligibles. For utilization in the hospital (e.g., ICU days or ICU days in terminal hospitalization), we will use UHC data.
- Doctor-patient relationship [ Time Frame: Every 3 months after enrollment up to 3 years ]Given the central role of the quality of the doctor-patient relationship on our conceptual model of care, we will administer the Primary Care Assessment Survey (discussed above) quarterly.
- Mortality [ Time Frame: Cumulative after enrollment up to 3 years ]Mortality will be assessed by report of key contacts and confirmed using death records.
- Provider outcomes [ Time Frame: Every 6 months beginning at the start of data collection up to 3 years ]Provider outcomes are also important. We have surveyed attending physician about job satisfaction for 15 years with multiple domains including satisfaction with ability to provide high quality care, efficient care, relationships with patients, relationships with providers, etc., and will continue these annually for all our attendings and for our CCPs. However, with only 5 CCPs, qualitative reports will be most valuable so we will interview them quarterly, transcribing comments for formal qualitative analysis. Given the tiny number of CCPs, all CCPs will be allowed to review resulting manuscripts before submission and redact elements as they feel appropriate, either out of personal interest or belief that a clinical reference might be identified with a specific patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929005
|Contact: Ainoa Coltri, MAfirstname.lastname@example.org|
|Contact: Gregory Ruhnke, MDemail@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Ainoa Coltri, MA 773-702-5956 firstname.lastname@example.org|
|Principal Investigator: David Meltzer, MD, PhD|
|Principal Investigator:||David Meltzer, MD, PhD||University of Chicago|