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MultimorbidityCEPIANCT02664454

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

A study testing health care organization in people with Multimorbidity and Geriatric Assessment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Multimorbidity, Geriatric Assessment
What is being tested?
health care organization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
1 siteFrance
Study dates
24 May 2016to 24 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Faculté de Médecine, Université Paris Est Créteil (UPEC)

    Créteil, 94010

Other trials in France

About this study

Official title: Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care: A Pragmatic Three-arm Cluster Randomized Controlled Trial

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.

Read more

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.

Being tested
health care organization
Keywords
Elderly, Health care organization, Primary care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • health care organizationOther

    Also called Nurse-led or GP-led Geriatric assessment combined with an educational seminar

    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

Study groups in NCT02664454
Study groupRoleWhat they receive
Systematic nurse-led GAExperimentalInteractive 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
Receives: Other: health care organization
GP-led GA on a case-by-case basis, as decided by the GPExperimentalInteractive 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
Receives: Other: health care organization
No interventionNo interventionNo educational seminar Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At 12 months

Secondary outcomes (13)

  1. Percentage of all-cause mortality

    Measured: At 12 months

  2. Percentage of Unplanned hospital admission

    Measured: At 12 months

  3. Percentage of Emergency visits

    Measured: At 12 months

  4. Percentage of Institutionalization

    Measured: At 12 months

  5. Quality of life (Duke profile score)

    Measured: At Day 0 and 12 months

  6. Autonomy by KATZ ALD score

    Measured: At Day 0 and 12 months

  7. Number of medication prescription (polypharmacy)

    Measured: Up to 12 months

  8. Percentage of Geriatric assessment performed

    Measured: Up to 12 months

  9. Percentage of personalized care plan performed

    Measured: Up to 12 months

  10. Percentage of geriatric phone advices requested by GPs

    Measured: Up to 12 months

  11. Percentage of health care actions planned

    Measured: Up to 12 months

  12. Percentage of satisfied general practitioner with the intervention

    self-assessment

    Measured: 27months after the beginning of the study

  13. Satisfaction of general practitioners and nurses after completion of intervention

    interview of general practionners and nurses by independant investigator

    Measured: 12 months after the beginning of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2016 (estimated)
  2. Study start24 May 2016
  3. Primary completion24 Aug 2018
  4. Study completion24 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
750 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02664454
Sponsor's protocol ID
K140707
Acronym
CEPIA
Status last verified
May 2024
First submitted
22 Jan 2016
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18387184

  • 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.

    PubMed 15381343

  • 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.

    PubMed 8105269

  • 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.

    PubMed 11866651

  • 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.

    PubMed 22790107

  • 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.

    PubMed 21735403

  • 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.

    PubMed 20171455

  • 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.

    PubMed 41469541

  • 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.

    PubMed 39334117

  • 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.

    PubMed 29654038

Questions about this trial

What is this clinical trial studying?

A study testing health care organization in people with Multimorbidity and Geriatric Assessment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary composite endpoint combined with: - Percentage of all-cause mortality - Percentage of Unplanned hospital admission - Percentage of Emergency visits. - Percentage of Institutionalization (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02664454, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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