Emergency Department VisitNCT04550169
Wisconsin Evaluation of Emergency Department Care Coordination
An observational study of Emergency Department Visit, run by University of Wisconsin, Madison at 4 sites in United States.
Trial summary
The State of Wisconsin is now expanding its investment in care coordination models as an effort to reduce inappropriate hospital emergency department (ED) use, improve health outcomes, and reduce Medicaid expenditures. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergency Department Visit
- What is being tested?
- Intensive Care Coordination
- How many people
- 3,405 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2022to 15 Dec 2024
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Inclusion Criteria: * Adults who are Medicaid enrolled * Have had 5+ emergency department visits in the past year Exclusion Criteria: * Participants who are concurrently eligible for Medicare * Children (individuals age <18 years).
Who may be able to join
- Adults who are Medicaid enrolled
- Have had 5+ emergency department visits in the past year
Who cannot join
- Participants who are concurrently eligible for Medicare
- Children (individuals age <18 years).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
ThedaCare
Appleton, Wisconsin, 54911
Ascension Wisconsin
Glendale, Wisconsin, 53217
Aurora Health Care
Milwaukee, Wisconsin, 53202
Froedtert Health , Wisconsin
Wauwatosa, Wisconsin, 53226
About this study
Official title: Evaluation of an Intensive Care Coordination Program to Reduce Use of Hospital Emergency Department Services by Wisconsin Medicaid Members
The State of Wisconsin is now expanding its investment in care coordination models as an effort to reduce inappropriate hospital emergency department (ED) use, improve health outcomes, and reduce Medicaid expenditures. This effort begins with a pilot program to support emergency department care coordination in hospitals and health systems that apply and are selected to participate in the pilot program.
The Wisconsin Medicaid program seeks to understand whether this program achieves its intended goals and, specifically, whether the Medicaid payment for such care coordination services produces the intended program outcomes. Hospitals will select members that will receive care coordination services. In a quasi-experimental approach, the study team will compare members that do vs. do not receive the services will be used examine the effects of care coordination and referrals on total ED visits, primary-care treatable ED visits, non-emergent ED visits, and health care costs, as well as the specific effects of referring patients to providers who offer low-cost and after-hours care. To assess the importance of targeting, study team will conduct stratified analyses of vulnerable groups such as people with disabilities and individuals with specific clinical needs.
- Conditions
- Emergency Department Visit
- Being tested
- Intensive Care Coordination
- Keywords
- Medicaid, CARES (Wisconsin Client Assistance for Re-Employment and Economic Support)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Care CoordinationOther
Intensive care coordination will include:
- Discharge instructions and contacts for following up on care and treatment
- Referral information
- Appointment scheduling
- Medication instructions
- Intensive care coordination by a social worker, case manager, nurse, or care coordinator to connect Medical Assistance (MA) recipient to a primary care provider or to a managed care organization
- Information about other health and social resources, such as transportation and housing
- Sharing of information (discharge instructions, medication information, and care plan information) with managed care organization in which patients are enrolled, if applicable
| Study group | Role | What they receive |
|---|---|---|
| Intensive Care Coordination | Intensive Care Coordination along with Standard of Care Receives: Other: Intensive Care Coordination | |
| Control | Standard of Care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Emergency Department Visits
Measured: 6 months
Total Number of Emergency Department Visits
Measured: 12 months
Total Number of Emergency Department Visits
Measured: 18 months
Total Number of Emergency Department Visits
Measured: 24 months
Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions
Measured: 6 months
Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions
Measured: 12 months
Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions
Measured: 18 months
Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions
Measured: 24 months
Cost to Medicaid for all Emergency Department Visits
Measured: 6 months
Cost to Medicaid for all Emergency Department Visits
Measured: 12 months
Cost to Medicaid for all Emergency Department Visits
Measured: 18 months
Cost to Medicaid for all Emergency Department Visits
Measured: 24 months
Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions
Measured: 6 months
Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions
Measured: 12 months
Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions
Measured: 18 months
Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions
Measured: 24 months
Secondary outcomes (13)
Total Number of Primary Care Visits
Measured: 6, 12, 18, and 24 months
Number of Participants Who Used Any Primary Care Visits
Measured: 6, 12, 18, and 24 months
Number of Participants Who Used Specialty Care Visits
Measured: 6, 12, 18, and 24 months
Total Number of Specialty Care Visits
Measured: 6, 12, 18, and 24 months
Number of Participants with Any Hospitalizations
Measured: 6, 12, 18, and 24 months
Number of Hospitalization Events
Measured: 6, 12, 18, and 24 months
Number of visits to use behavioral health resources, if applicable for the participant
Measured: 6, 12, 18, and 24 months
Number of visits to use alcohol and other drug abuse resources if applicable for the participant
Measured: 6, 12, 18, and 24 months
Total Cost Related to the Use of Behavioral Health Resources if applicable for the participant
Measured: 6, 12, 18, and 24 months
Total Cost Related to Use of Alcohol and other Drug Abuse Resources if applicable for the participant
Measured: 6, 12, 18, and 24 months
Total costs of care to Medicaid
Measured: 6, 12, 18, and 24 months
Number of participants enrolled in Temporary Assistance for Needy Families (TANF)
Measured: 6, 12, 18, and 24 months
Number of participants enrolled in FoodShare
FoodShare is a program that helps people with limited resources buy the food they need for good health.
Measured: 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Mar 2022
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Department VisitStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Prospective
- Enrolment
- 3,405 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Myerson, MPH, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550169
- Sponsor's protocol ID
- 2020-1211
- Other IDs
- MSN240705, A538500, SMPH/POP HEALTH SCI/POP HEALTH, Protocol Version April 2020
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2020
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intensive Care Coordination Program to Reduce Use of Hospital Emergency Department Services by Wisconsin Medicaid Members
- ClinicalTrials.gov ID
- NCT04550169
- Acronym / sponsor ID
- 2020-1211
- Conditions
- Emergency Department Visit
- Keywords
- Medicaid, CARES (Wisconsin Client Assistance for Re-Employment and Economic Support)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,405 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 16 Sep 2020 (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.
The State of Wisconsin is now expanding its investment in care coordination models as an effort to reduce inappropriate hospital emergency department (ED) use, improve health outcomes, and reduce Medicaid expenditures. This effort begins with a pilot program to support emergency department care coordination in hospitals and health systems that apply and are selected to participate in the pilot program.
The Wisconsin Medicaid program seeks to understand whether this program achieves its intended goals and, specifically, whether the Medicaid payment for such care coordination services produces the intended program outcomes. Hospitals will select members that will receive care coordination services. In a quasi-experimental approach, the study team will compare members that do vs. do not receive the services will be used examine the effects of care coordination and referrals on total ED visits, primary-care treatable ED visits, non-emergent ED visits, and health care costs, as well as the specific effects of referring patients to providers who offer low-cost and after-hours care. To assess the importance of targeting, study team will conduct stratified analyses of vulnerable groups such as people with disabilities and individuals with specific clinical needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Care Coordination | – | Other: Intensive Care CoordinationIntensive Care Coordination along with Standard of Care |
| Control | – | –Standard of Care alone |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Inclusion Criteria: * Adults who are Medicaid enrolled * Have had 5+ emergency department visits in the past year Exclusion Criteria: * Participants who are concurrently eligible for Medicare * Children (individuals age <18 years).
Key inclusion criteria (2 listed)
- Adults who are Medicaid enrolled
- Have had 5+ emergency department visits in the past year
Key exclusion criteria (2 listed)
- Participants who are concurrently eligible for Medicare
- Children (individuals age <18 years).
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 |
|---|---|---|
| Intensive Care CoordinationIntensive care coordination will include: * Discharge instructions and contacts for following up on care and treatment * Referral information * Appointment scheduling * Medication instructions * Intensive care coordination by a social worker, case manager, nurse, or care coordinator to connect Medical Assistance (MA) recipient to a primary care provider or to a managed care organization * Information about other health and social resources, such as transportation and housing * Sharing of information (discharge instructions, medication information, and care plan information) with managed care organization in which patients are enrolled, if applicable | Other | Intensive Care Coordination |
Primary outcome
Total Number of Emergency Department Visits
Time frame: 6 months
Total Number of Emergency Department Visits
Time frame: 12 months
Total Number of Emergency Department Visits
Time frame: 18 months
Total Number of Emergency Department Visits
Time frame: 24 months
Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions
Time frame: 6 months
Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions
Time frame: 12 months
Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions
Time frame: 18 months
Total Number of Emergency Department Visits for Primary Care Preventable and/or Non-Emergent Conditions
Time frame: 24 months
Cost to Medicaid for all Emergency Department Visits
Time frame: 6 months
Cost to Medicaid for all Emergency Department Visits
Time frame: 12 months
Cost to Medicaid for all Emergency Department Visits
Time frame: 18 months
Cost to Medicaid for all Emergency Department Visits
Time frame: 24 months
Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions
Time frame: 6 months
Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions
Time frame: 12 months
Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions
Time frame: 18 months
Cost to Medicaid for Emergency Department Use for Primary Care Preventable and/or Non-Emergent Conditions
Time frame: 24 months
13 secondary outcomes
Total Number of Primary Care Visits
Time frame: 6, 12, 18, and 24 months
Number of Participants Who Used Any Primary Care Visits
Time frame: 6, 12, 18, and 24 months
Number of Participants Who Used Specialty Care Visits
Time frame: 6, 12, 18, and 24 months
Total Number of Specialty Care Visits
Time frame: 6, 12, 18, and 24 months
Number of Participants with Any Hospitalizations
Time frame: 6, 12, 18, and 24 months
Number of Hospitalization Events
Time frame: 6, 12, 18, and 24 months
Number of visits to use behavioral health resources, if applicable for the participant
Time frame: 6, 12, 18, and 24 months
Number of visits to use alcohol and other drug abuse resources if applicable for the participant
Time frame: 6, 12, 18, and 24 months
Total Cost Related to the Use of Behavioral Health Resources if applicable for the participant
Time frame: 6, 12, 18, and 24 months
Total Cost Related to Use of Alcohol and other Drug Abuse Resources if applicable for the participant
Time frame: 6, 12, 18, and 24 months
Total costs of care to Medicaid
Time frame: 6, 12, 18, and 24 months
Number of participants enrolled in Temporary Assistance for Needy Families (TANF)
Time frame: 6, 12, 18, and 24 months
Number of participants enrolled in FoodShare
Time frame: 6, 12, 18, and 24 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 10 Jan 2025.
- 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.
Rebecca Myerson, MPH, PhD principal investigator
University of Wisconsin, Madison
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Department Visit, run by University of Wisconsin, Madison at 4 sites 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Total Number of Emergency Department Visits (time frame: 6 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.