- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934322
Case Management for Frequent Users of the Emergency Department
Case Management for Frequent Users of the Emergency Department: A Randomized Controlled Trial
The purpose of this study is to evaluate a specific case management intervention for frequent users (FU) of Emergency Department (ED).
Compared to infrequent or non-users, most of the ED-FU visitors are identified as vulnerable patients because they are more likely to be of low social and economical status, be more isolated and live alone. They report more chronic medical conditions, have a higher mortality rate and consume more healthcare resources.
In the literature, interventions aimed at improving the management of ED-FU have demonstrated several positive outcomes, but there are still some knowledge gaps.
The proposed project tests the hypotheses that case management intervention as compared with standard emergency care
- is a more efficient use of healthcare resources and reduces ED attendance,
- is cost-saving and
- improves quality of life,
- altogether leading to favorable cost-utility ratio.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lausanne, Switzerland, 1011
- University Hospital of Lausanne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 5 or more attendances during the previous 12 months at the Emergency Department of the University Hospital of Lausanne
- Be capable of communicating in any of the languages spoken by the team (i.e. French, English, German, Italian and Spanish) or through a community interpreter
Exclusion Criteria:
- Patients who cannot give informed consent or are ineligible to receive Case Managers services (e.g. acutely confused, acutely psychotic, intoxicated)
- Patients who are in prison
- Patients with a diagnose of cognitive disorders (delirium, dementia, and other cognitive disorders)
- Patients who are not expected to survive at least 18 months after enrollment
- Patients who will not remain in Switzerland for 12 to 18 months after enrollment
- Family members of a participant already included
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Case Management
Furnish specific assistance and to provide referrals for the patients:
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Furnish specific assistance and to provide referrals for the patients:
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No Intervention: Control
Patients randomized to control group (usual care) will receive standard emergency care by physicians (resident or attending physician) and nurses, without the case manager been involved.
Nevertheless, the mobile team will take contact with each patient of the control group, giving them short information through a flyer (flyer) which will underline the existence of the mobile team, its addresses and telephone numbers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of Emergency Department visits
Time Frame: 12 months after enrollement
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12 months after enrollement
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total costs of the healthcare resource
Time Frame: 12 months after enrollement
|
costs concerning services provided by the University Hospital of Lausanne and cost concerning services used outside the Hospital
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12 months after enrollement
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life
Time Frame: Day of enrollement, 2 months, 5.5 months, 9 months and 12 months
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Day of enrollement, 2 months, 5.5 months, 9 months and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bodenmann Patrick, PD, MER, MSc, University of Lausanne
Publications and helpful links
General Publications
- Bieler G, Paroz S, Faouzi M, Trueb L, Vaucher P, Althaus F, Daeppen JB, Bodenmann P. Social and medical vulnerability factors of emergency department frequent users in a universal health insurance system. Acad Emerg Med. 2012 Jan;19(1):63-8. doi: 10.1111/j.1553-2712.2011.01246.x. Epub 2012 Jan 5.
- Shumway M, Boccellari A, O'Brien K, Okin RL. Cost-effectiveness of clinical case management for ED frequent users: results of a randomized trial. Am J Emerg Med. 2008 Feb;26(2):155-64. doi: 10.1016/j.ajem.2007.04.021.
- Althaus F, Paroz S, Hugli O, Ghali WA, Daeppen JB, Peytremann-Bridevaux I, Bodenmann P. Effectiveness of interventions targeting frequent users of emergency departments: a systematic review. Ann Emerg Med. 2011 Jul;58(1):41-52.e42. doi: 10.1016/j.annemergmed.2011.03.007.
- Althaus F, Stucki S, Guyot S, Trueb L, Moschetti K, Daeppen JB, Bodenmann P. Characteristics of highly frequent users of a Swiss academic emergency department: a retrospective consecutive case series. Eur J Emerg Med. 2013 Dec;20(6):413-9. doi: 10.1097/MEJ.0b013e32835e078e.
- Iglesias K, Baggio S, Moschetti K, Wasserfallen JB, Hugli O, Daeppen JB, Burnand B, Bodenmann P. Using case management in a universal health coverage system to improve quality of life of frequent Emergency Department users: a randomized controlled trial. Qual Life Res. 2018 Feb;27(2):503-513. doi: 10.1007/s11136-017-1739-6. Epub 2017 Nov 29.
- Bodenmann P, Velonaki VS, Ruggeri O, Hugli O, Burnand B, Wasserfallen JB, Moschetti K, Iglesias K, Baggio S, Daeppen JB. Case management for frequent users of the emergency department: study protocol of a randomised controlled trial. BMC Health Serv Res. 2014 Jun 17;14:264. doi: 10.1186/1472-6963-14-264.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FNS 30023B_135762/1
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.
Clinical Trials on Frequent Users of the Emergency Department
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University of Lausanne HospitalsUnknownFrequent Users of Emergency Department (FUEDs)Switzerland
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Beth Israel Deaconess Medical CenterWithdrawnOperational Metrics of the Emergency DepartmentUnited States
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Aarhus University HospitalUnknownPoint of Care Ultrasonography in the Emergency Department.Denmark
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Health NavigatorVastra Gotaland Region; Region Stockholm; Ostergotland County Council, Sweden; Uppsala... and other collaboratorsUnknownThe Focus is to Investigate Effect of a Case Management Interventions in Frequent Visitors to Emergency DepartmentsSweden
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Beth Israel Deaconess Medical CenterWithdrawnScribes in the Emergency Department
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Jewish General HospitalActive, not recruitingPhysical Frailty | Cognitive Frailty | Older Emergency Department UsersCanada
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Hospital of South West JutlandUniversity of Southern DenmarkCompletedMedical Patients in the Emergency DepartmentDenmark
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Meir Medical CenterUnknownChildren Referred to the Pediatric Emergency DepartmentIsrael
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Assistance Publique - Hôpitaux de ParisCompletedElderly Patients Visiting the Emergency DepartmentFrance
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CHU de ReimsCompletedthe Observance of Emergency Exit Treatments During the Stay of Care at the Exit of Reims EmergenciesPatient Coming to the Emergency Department for Any ReasonFrance
Clinical Trials on Case Management
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National Taiwan University HospitalCompleted
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Minneapolis Veterans Affairs Medical CenterCompletedDiabetes MellitusUnited States
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New York State Psychiatric InstituteEmory UniversityCompletedDepressive Disorder | Bipolar Disorder | Mental Disorders, Severe | Schizophrenia and Related Disorders
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Johns Hopkins UniversityJohns Hopkins Community PhysiciansWithdrawnSubstance-related DisorderUnited States
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Centre Hospitalier Universitaire de NīmesRecruiting
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Kaiser PermanenteNot yet recruiting
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Dalin Tzu Chi General HospitalCompletedArthritis, Rheumatoid | Case Management | Managed Care ProgramsTaiwan
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Yong Seog OhUnknown
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National Clinical Research Coordination Center,...CompletedMajor Depressive Disorders | Senile; DepressionKorea, Republic of