NCT02664454

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

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

First Submitted

Initial submission to the registry

January 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

May 24, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2018

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

January 22, 2016

Last Update Submit

May 15, 2024

Conditions

Keywords

ElderlyHealth care organizationPrimary care

Outcome Measures

Primary Outcomes (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 Outcomes (13)

  • Percentage of all-cause mortality

    At 12 months

  • Percentage of Unplanned hospital admission

    At 12 months

  • Percentage of Emergency visits

    At 12 months

  • Percentage of Institutionalization

    At 12 months

  • Quality of life (Duke profile score)

    At Day 0 and 12 months

  • +8 more secondary outcomes

Study Arms (3)

Systematic nurse-led GA

EXPERIMENTAL

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

GP-led GA on a case-by-case basis, as decided by the GP

EXPERIMENTAL

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

No intervention

NO INTERVENTION

No educational seminar Usual care

Interventions

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

Also known as: Nurse-led or GP-led Geriatric assessment combined with an educational seminar
GP-led GA on a case-by-case basis, as decided by the GPSystematic nurse-led GA

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculté de Médecine, Université Paris Est Créteil (UPEC)

Créteil, 94010, France

Location

Related Publications (10)

  • Bouman A, van Rossum E, Nelemans P, Kempen GI, Knipschild P. Effects of intensive home visiting programs for older people with poor health status: a systematic review. BMC Health Serv Res. 2008 Apr 3;8:74. doi: 10.1186/1472-6963-8-74.

  • Kuo HK, Scandrett KG, Dave J, Mitchell SL. The influence of outpatient comprehensive geriatric assessment on survival: a meta-analysis. Arch Gerontol Geriatr. 2004 Nov-Dec;39(3):245-54. doi: 10.1016/j.archger.2004.03.009.

  • Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6. doi: 10.1016/0140-6736(93)92884-v.

  • Stuck AE, Egger M, Hammer A, Minder CE, Beck JC. Home visits to prevent nursing home admission and functional decline in elderly people: systematic review and meta-regression analysis. JAMA. 2002 Feb 27;287(8):1022-8. doi: 10.1001/jama.287.8.1022.

  • Frese T, Deutsch T, Keyser M, Sandholzer H. In-home preventive comprehensive geriatric assessment (CGA) reduces mortality--a randomized controlled trial. Arch Gerontol Geriatr. 2012 Nov-Dec;55(3):639-44. doi: 10.1016/j.archger.2012.06.012. Epub 2012 Jul 11.

  • Ellis G, Whitehead MA, O'Neill D, Langhorne P, Robinson D. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD006211. doi: 10.1002/14651858.CD006211.pub2.

  • Li CM, Chen CY, Li CY, Wang WD, Wu SC. The effectiveness of a comprehensive geriatric assessment intervention program for frailty in community-dwelling older people: a randomized, controlled trial. Arch Gerontol Geriatr. 2010 Feb;50 Suppl 1:S39-42. doi: 10.1016/S0167-4943(10)70011-X.

  • Orcel V, Ferrat E, Moscova L, Vigneron L, Michau B, Cittee J, Adeline F, Audureau E, Hagege M. Barriers to and facilitators of comprehensive geriatric assessment in primary care in France: a qualitative study exploring physicians' and nurses' experiences. BMC Prim Care. 2025 Dec 30;26(1):414. doi: 10.1186/s12875-025-03085-5.

  • Orcel V, Banh L, Bastuji-Garin S, Renard V, Boutin E, Gouja A, Caillet P, Paillaud E, Audureau E, Ferrat E. Effectiveness of comprehensive geriatric assessment adapted to primary care when provided by a nurse or a general practitioner: the CEpiA cluster-randomised trial. BMC Med. 2024 Sep 27;22(1):414. doi: 10.1186/s12916-024-03613-7.

  • Ferrat E, Bastuji-Garin S, Paillaud E, Caillet P, Clerc P, Moscova L, Gouja A, Renard V, Attali C, Breton JL, Audureau E. Efficacy of nurse-led and general practitioner-led comprehensive geriatric assessment in primary care: protocol of a pragmatic three-arm cluster randomised controlled trial (CEpiA study). BMJ Open. 2018 Apr 12;8(4):e020597. doi: 10.1136/bmjopen-2017-020597.

Study Officials

  • Emilie Ferrat, MCU-MG

    Université Paris Est (UPEC), IMRB, A-TVB DHU, CEpiA EA 7376 (Clinical Epidemiology and Ageing Unit)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

May 24, 2016

Primary Completion

August 24, 2018

Study Completion

August 24, 2018

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations