CEPIA: Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Unknown status
CT.gov ID
NCT02664454
Collaborator
(none)
750
1
3
27
27.8

Study Details

Study Description

Brief Summary

Older patients account for around 10% of the population, of which 57% have a long-term illness, and 33% were admitted in the past year.

Geriatric assessment (GA) is a multidimensional assessment of general health status that can help identifying deficiencies and followed by a personalized care plan.

Assessment and management of elderly patients is a daily concern for the general practitioner (GP) but conflicting results have been reported so far relating to the clinical impact of GA when applied in the primary care setting.

This study protocol aims to assess the effect on morbi-mortality of a complex intervention in patients aged ≥70 years with chronic conditions in primary care. It aims to demonstrate that a GA adapted to primary care, followed by a personalized care plan and combined with successful interprofessional collaboration can improve clinically relevant outcomes in elderly patients with chronic conditions such as one-year overall mortality, unplanned hospital admission, emergency visits, or institutionalization.

The CEPIA study will also help addressing the issue of whether an improved benefit could be achieved from a systematic nurse-led or a case-by-case GP-led GA.

Condition or Disease Intervention/Treatment Phase
  • Other: health care organization
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
750 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care: A Pragmatic Three-arm Cluster Randomized Controlled Trial
Actual Study Start Date :
May 24, 2016
Anticipated Primary Completion Date :
Aug 24, 2018
Anticipated Study Completion Date :
Aug 24, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Systematic nurse-led GA

Interactive educational seminar for GPs and nurses, and focused on geriatric assessment in primary care combined with Systematic nurse-led GA and dedicated hotline for GPs seeking geriatric advice

Other: health care organization
Nurse-led or GP-led Geriatric assessment combined with an educational seminar focused on GA and personalized care-plan as well as a dedicated hotline for general practitioners seeking a geriatric advice Interactive educational seminar Primary care
Other Names:
  • Nurse-led or GP-led Geriatric assessment combined with an educational seminar
  • Experimental: GP-led GA on a case-by-case basis, as decided by the GP

    Interactive educational seminar for GPs, and focused on Geriatric assessment in primary care combined with a GP-led GA on a case-by-case basis, as decided by the GP, and a dedicated hotline for GPs seeking geriatric advice

    Other: health care organization
    Nurse-led or GP-led Geriatric assessment combined with an educational seminar focused on GA and personalized care-plan as well as a dedicated hotline for general practitioners seeking a geriatric advice Interactive educational seminar Primary care
    Other Names:
  • Nurse-led or GP-led Geriatric assessment combined with an educational seminar
  • No Intervention: No intervention

    No educational seminar Usual care

    Outcome Measures

    Primary Outcome Measures

    1. Primary composite endpoint combined with: - Percentage of all-cause mortality - Percentage of Unplanned hospital admission - Percentage of Emergency visits. - Percentage of Institutionalization [At 12 months]

    Secondary Outcome Measures

    1. Percentage of all-cause mortality [At 12 months]

    2. Percentage of Unplanned hospital admission [At 12 months]

    3. Percentage of Emergency visits [At 12 months]

    4. Percentage of Institutionalization [At 12 months]

    5. Quality of life (Duke profile score) [At Day 0 and 12 months]

    6. Autonomy by KATZ ALD score [At Day 0 and 12 months]

    7. Number of medication prescription (polypharmacy) [Up to 12 months]

    8. Percentage of Geriatric assessment performed [Up to 12 months]

    9. Percentage of personalized care plan performed [Up to 12 months]

    10. Percentage of geriatric phone advices requested by GPs [Up to 12 months]

    11. Percentage of health care actions planned [Up to 12 months]

    12. Percentage of satisfied general practitioner with the intervention [27months after the beginning of the study]

      self-assessment

    13. Satisfaction of general practitioners and nurses after completion of intervention [12 months after the beginning of the study]

      interview of general practionners and nurses by independant investigator

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged≥70 years with a long-term illness scheme or hospital admission the past 3 months

    • Visiting their preferred general practioner (GP) or another GP in the same practice

    • patient oral non opposition

    Exclusion Criteria:
    • Patient who does not speak French

    • Severe disease with a life expectancy <12 months

    • Institutionalized patients

    • Patient insured under the French national health insurance system

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculté de Médecine, Université Paris Est Créteil (UPEC) Creteil France 94010

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Emilie Ferrat, MCU-MG, Université Paris Est (UPEC), IMRB, A-TVB DHU, CEpiA EA 7376 (Clinical Epidemiology and Ageing Unit)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT02664454
    Other Study ID Numbers:
    • K140707
    First Posted:
    Jan 27, 2016
    Last Update Posted:
    Jul 26, 2017
    Last Verified:
    Jun 1, 2017
    Keywords provided by Assistance Publique - Hôpitaux de Paris

    Study Results

    No Results Posted as of Jul 26, 2017