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Impact of Systematic Tracking of Dementia Cases on the Rate of Hospitalization in Emergency Care Units (IDEM)

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01569997
First received: July 4, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

Introduction: Epidemiological data show that in France only half of patients with Alzheimer disease are currently diagnosed in the general population. The absence of early diagnosis of dementia reduces the opportunities of patients to receive optimal care. One of the consequences of undiagnosed dementia is inadequate use of emergency care units.

The main objective: The main aim of this study is to evaluate the impact of a systematic case-finding procedure of dementia cases in nursing homes through a MDTM on the rate of hospitalization in emergency care units.

Secondary objectives:

To assess the impact of systematic tracking of dementia cases on the:

  • Quantity and quality of drug-prescription
  • Appropriateness of hospitalizations
  • Prevalence of neuropsychiatric symptoms
  • Dependency
  • Quality of life
  • Burden of nursing staff working conditions
  • Planning of specific therapeutic measures
  • Overall health care costs

Condition Intervention
Dementia in Nursing Home
 Other: MultiDisciplinary Team Meetings (MDTM)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Interest of Systematic Tracking of Dementia Cases in Nursing Homes: Analysing the Contribution of MultiDisciplinary Team Meeting (MDTM) in Alzheimer's Disease and Related Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Incidence of hospitalizations in emergency care units [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Monthly collection during follow-up (18 months)


Secondary Outcome Measures:
  • Prevalence of antipsychotic prescription [ Time Frame: Baseline visit, 4 months, 18 months ] [ Designated as safety issue: No ]
  • Incidence of inappropriate hospitalizations [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Monthly collection during follow-up (18 months)

  • Prevalence of neuropsychiatric symptoms evaluated by NPI-nursing staff version [ Time Frame: Baseline visit, 18 months ] [ Designated as safety issue: No ]
  • Dependency evaluated by AGGIR and IADL-4 items [ Time Frame: Baseline visit, 18 months ] [ Designated as safety issue: No ]
  • Quality of life evaluated by QOL-AD [ Time Frame: Baseline visit, 18 months ] [ Designated as safety issue: No ]
  • Number of nursing staff's time off work [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Monthly collection during follow-up (18 months)

  • Number of days off work by nursing staff [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Monthly collection during follow-up (18 months)

  • Presence of advanced care planning in patients medical records [ Time Frame: Baseline visit, 18 months ] [ Designated as safety issue: No ]
    Advanced care planning will be checked through behavioural disosders, transfer to hospital intensive care and resuscitation

  • Overall healthcare costs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Monthly collection during follow-up (18 months)


Estimated Enrollment: 2000
Study Start Date: May 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention group
Intervention group: nursing homes whose residents benefit from MDTM to identify the cases of dementia and to propose an adequate care project
 Other: MultiDisciplinary Team Meetings (MDTM)
The MDTM, between the memory experts and Nursing Home coordinating practitioners, could help the nursing home medical staff identify the cases of dementia and propose these residents an adequate healthcare project (supplementary investigations, therapeutic modifications, hospitalizations...)
No Intervention: control group
Control group: nursing homes whose residents continue to benefit from usual care

Detailed Description:

This is a multicentre, cluster randomized study comparing two parallel groups:

  • Intervention group: nursing homes whose residents benefit from MDTM to identify the cases of dementia and to propose an adequate care project
  • Control group: nursing homes whose residents continue to benefit from usual care In each group, 1000 elderly subjects aged over 60 years without documented diagnosis of dementia will be included and monitored for a period of 18 months.

Information about the main and secondary aims will be collected monthly through online questionnaires.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Residents of both sex, aged 60 years or over
  • Residents living in a nursing home participating in the study
  • Residents living in the nursing home for 30 days or more

  • Residents without diagnosed and documented dementia, identified as follows:

    • residents not identified by the French Healthcare system as suffering from dementia (ALD 15)
    • residents not benefiting from a specific care program or a specialized follow-up for dementia
    • residents for whom there is no appropriate investigation for dementia diagnosis in medical records
    • residents not taking specific drugs for dementia (Cholinesterase inhibitors and/or Memantine)
  • Residents and their GP having received information about the study
  • Residents and their GP having expressed their agreement to participate in the study

Exclusion Criteria:

  • Residents aged less than 60 years
  • Residents not living in a nursing home participating in study
  • Residents living in nursing home for less than 30 days

  • Residents with diagnosed and documented dementia, identified as follows:

    • residents Identified by the French Healthcare system as suffering from dementia (ALD 15)
    • residents benefiting from specific care programme or specialized follow-up for dementia
    • residents for whom there is appropriate investigation for dementia diagnosis in medical records
    • residents taking specific drugs for dementia (Cholinesterase inhibitors and/or Memantine)
  • Residents and/or their GP who received no information about the study
  • Residents and/or their GP having expressed their opposition to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569997

Contacts
Contact: Yves ROLLAND, MD, PhD 05 34 55 76 07 ext 33 rolland.y@chu-toulouse.fr
Contact: Neda TAVASSOLI, PharmD, PhD 05 61 77 64 94 ext 33 tavassoli.n@chu-toulouse.fr

  Show 91 Study Locations
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Pierre ALLAN, MD EHPAD MAISON DE RETRAITE SAINT JOSEPH - MAZAMET
Principal Investigator: Véronique ARNAUD-ULLIET, MD EHPAD MA MAISON MONTPELLIER
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01569997     History of Changes
Other Study ID Numbers: 0910701, 2009-A01062-55
Study First Received: July 4, 2011
Last Updated: January 22, 2013
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
nursing home
Dementia
emergency hospitalization
multidisciplinary meeting
cognitive decline
disability
 residents
facilities
long term care unit
health policy
general practitioner
prevention

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013