Vulnerable Populations Clinical Trial
Official title:
Case Management for Frequent Users of the Emergency Department: A Randomized Controlled Trial
Verified date | May 2015 |
Source | University of Lausanne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Lausanne | Lausanne |
Lead Sponsor | Collaborator |
---|---|
University of Lausanne |
Switzerland,
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of life | Day of enrollement, 2 months, 5.5 months, 9 months and 12 months | No | |
Primary | number of Emergency Department visits | 12 months after enrollement | No | |
Secondary | total costs of the healthcare resource | costs concerning services provided by the University Hospital of Lausanne and cost concerning services used outside the Hospital | 12 months after enrollement | No |
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