NCT01934322

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.1 years

First QC Date

August 29, 2013

Last Update Submit

May 26, 2015

Conditions

Keywords

frequent users of the emergency departmentvulnerable populationscase managementcost savings interventionquality of lifenumber of emergency department visits

Outcome Measures

Primary Outcomes (1)

  • number of Emergency Department visits

    12 months after enrollement

Secondary Outcomes (1)

  • total costs of the healthcare resource

    12 months after enrollement

Other Outcomes (1)

  • Quality of life

    Day of enrollement, 2 months, 5.5 months, 9 months and 12 months

Study Arms (2)

Case Management

EXPERIMENTAL

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.

Other: Case Management

Control

NO INTERVENTION

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.

Interventions

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.

Case Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Related Publications (6)

  • 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.

    PMID: 21689565BACKGROUND
  • 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.

    PMID: 22221292BACKGROUND
  • 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.

    PMID: 23337095BACKGROUND
  • 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.

    PMID: 18272094BACKGROUND
  • 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.

MeSH Terms

Interventions

Case Management

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Bodenmann Patrick, PD, MER, MSc

    University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD, MER, MSc

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 4, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations