Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01934322
Other study ID # FNS 30023B_135762/1
Secondary ID
Status Completed
Phase N/A
First received August 29, 2013
Last updated May 26, 2015
Start date June 2012
Est. completion date July 2014

Study information

Verified date May 2015
Source University of Lausanne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Case Management
Furnish specific assistance and to provide referrals for the patients: If the social determinants are not adequate, the team will lend assistance for obtaining income entitlements, health insurance coverage if eligible, stable housing, schooling for children, etc. If there are mental disturbances, the team will refer to mental health departments inside the hospital, and if necessary, to a psychiatrist, psychologist or general practitioner (GP) out in the community. If the patient presents risk behaviors, the team will refer to substance abuse services and links to community services in order to maintain continuity of care. In case of somatic problems, the team will find a new GP or make contact with the previous provider, contingent on the patient's consent.

Locations

Country Name City State
Switzerland University Hospital of Lausanne Lausanne

Sponsors (1)

Lead Sponsor Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05228886 - The SINCERE Intervention to Address COVID-19 Health Disparities N/A
Not yet recruiting NCT05544578 - Korean Translation and Validation of the K- HEPI by a Phase 1 Feasibility Study in NYC N/A
Completed NCT05455580 - Nurses Taking On Readiness Measures - Mercer County, New Jersey N/A
Completed NCT03456921 - Using an End-of-life Conversation Game to Engage Underserved Communities in Advance Care Planning N/A
Not yet recruiting NCT05972421 - Enrollment in and Utilization of the Flex Nutrition Program N/A