- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03293160
An Evaluation of the Michigan State Innovation Model in Washtenaw and Livingston Counties
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In 2017, the State of Michigan will offer enrollment in care management services to a set of patients in Washtenaw and Livingston Counties who are predicted to be high-frequency users of emergency departments. This is a quality improvement initiative. The Center for Healthcare Research and Transformation (CHRT) will administer this enrollment and collect patient data. The Principal Investigators will conduct a study that uses the data from this quality improvement initiative to compare the outcomes of the treatment and control groups. Specifically, the study will examine whether the care management services had an effect on the number of emergency department visits and the total healthcare spending of the patients in the treatment group.
The present study therefore is the second of two related projects - the first is the CHRT-administered random assignment and enrollment of patients into care management services. The present study is a secondary analysis of the data produced by the first project.
This Protocol Registration and Results submission refers to the secondary analysis component wherever applicable, and where not applicable, describes the information relevant to the CHRT project. For example, while the present study does not assign anyone into treatment or control groups, the Sample Description indicates "Probability Sample" to describe the way in which CHRT intends to enroll patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105
- Center for Healthcare Research & Transformation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- reside in Washtenaw or Livingston counties or have an unknown address;
- Have a probability of being admitted to an emergency department (ED) in Washtenaw or Livingston counties that exceeds a threshold value in a predictive model;
Exclusion criteria
- Patients referred by a community provider
- Patient declines to consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Treatment group
The set of patients in the sample who are offered enrollment in care management services.
|
Patients who receive care management services will interact with a care manager who will take an inventory of the patient's needs (including social determinants of health such as housing) and provide guidance about available social supports and clinical resources.
|
|
Control group
The set of patients in the sample who are not initially offered enrollment in care management services (will be offered enrollment after six months).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency department utilization
Time Frame: 6 months
|
Number of emergency department visits per patient
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health care spending
Time Frame: 6 months
|
Dollars of health care spending incurred by patient
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Marianne Udow-Phillips, MHSA, Center for Healthcare Research & Transformation
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00133309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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