High Utilization of Emergency DepartmentsNCT03293160
An Evaluation of the Michigan State Innovation Model in Washtenaw and Livingston Counties
An observational study of High Utilization of Emergency Departments, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- High Utilization of Emergency Departments
- What is being tested?
- Care management services
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who frequently use the emergency department of hospitals located in Washtenaw or Livingston Counties.
Who may be able to join
- 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;
Who cannot join
- Patients referred by a community provider
- Patient declines to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Healthcare Research & Transformation
Ann Arbor, Michigan, 48105
About this study
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.
Read the 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.
- Being tested
- Care management services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care management servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | The set of patients in the sample who are offered enrollment in care management services. Receives: Other: Care management services | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Emergency department utilization
Number of emergency department visits per patient
Measured: 6 months
Secondary outcomes (1)
Health care spending
Dollars of health care spending incurred by patient
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Utilization of Emergency DepartmentsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Healthcare Research and Transformation, Community Foundation of Southeast Michigan
- Responsible party
- Principal investigator, Brady Post, University of Michigan
- Investigators
- Marianne Udow-Phillips, MHSA, Study director, Center for Healthcare Research & Transformation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293160
- Sponsor's protocol ID
- HUM00133309
- Status last verified
- May 2020
- First submitted
- 21 Sep 2017
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Post B, Lapedis J, Singh K, Valenstein P, Buyuktur AG, Teske K, Ryan AM. Predictive Model-Driven Hotspotting to Decrease Emergency Department Visits: a Randomized Controlled Trial. J Gen Intern Med. 2021 Sep;36(9):2563-2570. doi: 10.1007/s11606-021-06664-1. Epub 2021 Mar 10.
PubMed 33694072
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Michigan State Innovation Model in Washtenaw and Livingston Counties
- ClinicalTrials.gov ID
- NCT03293160
- Acronym / sponsor ID
- HUM00133309
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Center for Healthcare Research and Transformation, Community Foundation of Southeast Michigan
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Other: Care management servicesThe set of patients in the sample who are offered enrollment in care management services. |
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who frequently use the emergency department of hospitals located in Washtenaw or Livingston Counties.
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (2 listed)
- Patients referred by a community provider
- Patient declines to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care management servicesPatients 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. | Other | Treatment group |
Primary outcome
Emergency department utilization
Time frame: 6 months
Number of emergency department visits per patient
1 secondary outcome
Health care spending
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Derived from this study: PubMed 33694072Post B, Lapedis J, Singh K, Valenstein P, Buyuktur AG, Teske K, Ryan AM. Predictive Model-Driven Hotspotting to Decrease Emergency Department Visits: a Randomized Controlled Trial. J Gen Intern Med. 2021 Sep;36(9):2563-2570. doi: 10.1007/s11606-021-06664-1. Epub 2021 Mar 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Udow-Phillips, MHSA study director
Center for Healthcare Research & Transformation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Utilization of Emergency Departments, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency department utilization (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03293160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.