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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03293160
Other study ID # HUM00133309
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date December 31, 2019

Study information

Verified date May 2020
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will examine the effects of a care management program on the health and health spending outcomes of patients residing in Michigan's Washtenaw and Livingston Counties.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria:

1. reside in Washtenaw or Livingston counties or have an unknown address;

2. 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

1. Patients referred by a community provider

2. Patient declines to consent

Study Design


Related Conditions & MeSH terms

  • Emergencies
  • High Utilization of Emergency Departments

Intervention

Other:
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.

Locations

Country Name City State
United States Center for Healthcare Research & Transformation Ann Arbor Michigan

Sponsors (3)

Lead Sponsor Collaborator
University of Michigan Center for Healthcare Research and Transformation, Community Foundation of Southeast Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emergency department utilization Number of emergency department visits per patient 6 months
Secondary Health care spending Dollars of health care spending incurred by patient 6 months