Clinical trial NCT02664454: Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care
Official title: Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care: A Pragmatic Three-arm Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity
Geriatric Assessment
Keywords: Elderly
Health care organization
Primary care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 750
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary composite endpoint combined with: - Percentage of all-cause mortality - Percentage of Unplanned hospital admission - Percentage of Emergency visits. - Percentage of Institutionalization
timeFrame: At 12 months
Secondary outcomes:
measure: Percentage of all-cause mortality
timeFrame: At 12 months
measure: Percentage of Unplanned hospital admission
timeFrame: At 12 months
measure: Percentage of Emergency visits
timeFrame: At 12 months
measure: Percentage of Institutionalization
timeFrame: At 12 months
measure: Quality of life (Duke profile score)
timeFrame: At Day 0 and 12 months
measure: Autonomy by KATZ ALD score
timeFrame: At Day 0 and 12 months
measure: Number of medication prescription (polypharmacy)
timeFrame: Up to 12 months
measure: Percentage of Geriatric assessment performed
timeFrame: Up to 12 months
measure: Percentage of personalized care plan performed
timeFrame: Up to 12 months
measure: Percentage of geriatric phone advices requested by GPs
timeFrame: Up to 12 months
measure: Percentage of health care actions planned
timeFrame: Up to 12 months
measure: Percentage of satisfied general practitioner with the intervention
timeFrame: 27months after the beginning of the study
measure: Satisfaction of general practitioners and nurses after completion of intervention
timeFrame: 12 months after the beginning of the study
Other outcomes:
Locations:
city: Creteil
country: France
facility: Faculté de Médecine, Université Paris Est Créteil (UPEC)
Study officials:
affiliation: Université Paris Est (UPEC), IMRB, A-TVB DHU, CEpiA EA 7376 (Clinical Epidemiology and Ageing Unit)
name: Emilie Ferrat, MCU-MG
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.