Comprehensive Care Community and Culture Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
This randomized trial is evaluating whether socioeconomically disadvantaged Medicare patients at increased risk of hospitalization experience fewer hospitalization if those patients are offered care in: 1) ACCT, where patients receive care from different physicians in the hospital and the clinic settings and have access to nurse and social worker care coordination services, 2) CCP where patients receive care from one physician in the inpatient and outpatient settings or 3) C4P which adds screening of unmet social needs, community health worker support and arts and culture programming to CCP. The study will determine how these programs affect patient activation and engagement in care, satisfaction with care, general health and mental health, and goal attainment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must have Medicare Part A and Part B
Must have been hospitalized once in the past 2 years or be in emergency department at time recruitment is initiated
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Ambulatory Care Coordinator Team (ACCT)
BehavioralSee arm description
Comprehensive Care Physician Program (CCP)
Behavioralsee arm description
Comprehensive Care Community & Culture Program (C4P)
Behavioralsee arm description
Treatment groups
3,000 Participants
are divided into 3 treatment groupsGroup A: Ambulatory Care Coordinator Team (ACCT)Active comparator 1 intervention
Group B: Comprehensive Care Physician (CCP)Active comparator 1 intervention
Group C: Comprehensive Care, Community & Culture Program (C4P)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quarterly hospitalization rate
Number of hospitalizations per quarter
Time frame
Through study completion, with a range of 1 to 4.5 yearsSecondary outcomes
1
Quarterly hospitalization rate from all sources
Combines Medicare, Illinois State Department of Public Health (IDPH) hospitalization data, patient self report
Time frame
Through study completion, with a range of 1 to 4.5 years2
Patient experience
Self reported Consumer assessment of Health Care Providers and Systems Survey (CAHPS) overall satisfaction with provider
Time frame
Through study completion, with a range of 1 to 4.5 years3
Health Outcomes General Health
Patient-Reported Outcomes Measurement Information System (PROMIS) GLOBAL General Health Measure Single Item--In general, would you say your/patients health is: Excellent/very good/good/fair/poor/don't know/refused
Time frame
Through study completion, with a range of 1 to 4.5 years4
Health Outcomes Mental Health
PROMIS GLOBAL Mental Health MeasurePROMIS GLOBAL General Health Measure Single Item--In general, how would you rate (your/PATIENT'S) mental health, including (your/PATIENT) mood and (your/PATIENT'S)ability to think: Excellent/very good/good/fair/poor/don't know/refused
Time frame
Through study completion, with a range of 1 to 4.5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov