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

Multimorbidity Clinical Trial

— CEPIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664454
• Other study ID #: K140707
• Status: Completed
• Phase: N/A
• Start date: May 24, 2016
• Est. completion date: August 24, 2018

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: August 24, 2018
• Est. primary completion date: August 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatric Assessment
• Multimorbidity

Intervention

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

Locations

Country	Name	City	State
France	Faculté de Médecine, Université Paris Est Créteil (UPEC)	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View 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. — View 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 1 — View 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. — View 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: 1 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of all-cause mortality		At 12 months
Secondary	Percentage of Unplanned hospital admission		At 12 months
Secondary	Percentage of Emergency visits		At 12 months
Secondary	Percentage of Institutionalization		At 12 months
Secondary	Quality of life (Duke profile score)		At Day 0 and 12 months
Secondary	Autonomy by KATZ ALD score		At Day 0 and 12 months
Secondary	Number of medication prescription (polypharmacy)		Up to 12 months
Secondary	Percentage of Geriatric assessment performed		Up to 12 months
Secondary	Percentage of personalized care plan performed		Up to 12 months
Secondary	Percentage of geriatric phone advices requested by GPs		Up to 12 months
Secondary	Percentage of health care actions planned		Up to 12 months
Secondary	Percentage of satisfied general practitioner with the intervention	self-assessment	27months after the beginning of the study
Secondary	Satisfaction of general practitioners and nurses after completion of intervention	interview of general practionners and nurses by independant investigator	12 months after the beginning of the study