Clinical trial NCT02618291: Efficacy of an Active Geriatric Evaluation for Geriatric Syndromes to Prevent Functional Decline in Family Medicine
Official title: Efficacy of a an Active Geriatric Evaluation (AGE Tool) for Geriatric Syndromes to Prevent Functional Decline in Elderly Patients in Family Medicine: a Pragmatic Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Syndrome
Functional Ability
Keywords: primary health care
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 429
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to test the efficacy of a comprehensive assessment and management tool (AGE: Active Geriatric Evaluation) for geriatric syndromes to prevent functional decline in elderly patients followed in family medicine. Family practitioners will be randomised either to the intervention, consisting of a yearly screening for eight geriatric syndromes accompanied by a management plan in case of positive screening, or to usual care. Level of functioning and quality of life of patients in both arms will be assessed over two years.

Detailed description: The ageing of the population is associated to a rapid increase of chronic conditions and more specifically geriatric syndromes for which the health care system is largely unprepared. Being in frontline of this huge arising burden, family practitioners (FP) will need adapted tools to identify and manage elderly patients with complex needs and prevent functional decline while improving quality of life. It is however well recognized that effective and efficient evidence-based interventions adapted to the primary care setting are lacking. The AGE program (Active Geriatric Evaluation) was launched in 2011 and aimed at developing a comprehensive assessment and management tool for FP's to better identify and manage geriatric syndromes. The AGE tool consists of a 20-minute clinical screening instrument (Brief Assessment Tool, BAT), which performances for identifying geriatric syndromes was already assessed in general practice along the AGE program, and a comprehensive approach that encompasses: complementary diagnostic evaluations and propositions of management \& treatment for each syndrome. The efficacy and efficiency of the AGE tool for preventing functional decline was never assessed in real life settings of general practice.

The aim of the study is to determine whether a comprehensive tool combining a brief assessment tool (BAT) for the early diagnosis of geriatric syndromes with a structured diagnostic and management strategy impacts on the functional decline and quality of life of elderly patients.

Design: Two-arm open label cluster randomized trial in FP practices, randomization unit: FP

Participants and setting: FP's and their patients aged ≥ 75 years in the French part of Switzerland. In total: 40 FP's (2x20) and 400 patients (2 x 200)

Intervention: Active Geriatric Evaluation. Controls: Usual care provided by FP's. Duration of study: 3 years (2 years of follow-up). Expected outcomes:functional ability of patients in the intervention arm ,measured through the activities of daily living, will be conserved compared to patients in the usual care arm.

Eligibility criteria: Inclusion Criteria:

* Aged 75 years or more
* Consider the enrolling physician as his/her reference FP
* Able to understand French
* Living at home (not in institutions)
* Visited his/her FP at least twice during the past year
* Giving signed informed consent (or, in the absence of discerning capacity, giving assent in the presence of a surrogate signing the consent form)

Exclusion Criteria:

* Having had a geriatric or specialized memory consultation in the past 3 months (including assessment during rehabilitation)
* Planning to leave the study area or to change of FP in the next 2 years

Primary outcomes:
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: 2 years
measure: Basic Activities of Daily Living (ADL)
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of hospital admissions
timeFrame: During 2 years
measure: Incidence of institutionalization
timeFrame: During 2 years
measure: Incidence of emergency visits
timeFrame: During 2 years
measure: Incidence of outpatient visits
timeFrame: During 2 years
measure: Health related quality of life (WHOQOL-OLD) score
timeFrame: 2 years
Other outcomes:
measure: Adhesion to Active Geriatric Evaluation Tool
timeFrame: 2 years
measure: Total cost
timeFrame: 2 years
Locations:
city: Lausanne
country: Switzerland
facility: Department of Ambulatory Care and Community Medicine
state: Vaud
Study officials:
affiliation: Department of community medicine and ambulatory care, University of Lausanne
name: Nicolas Senn, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller Y, Schwarz J, Monod S, Locatelli I, Senn N. Use of standardized brief geriatric evaluation compared with routine care in general practice for preventing functional decline: a pragmatic cluster-randomized trial. CMAJ. 2021 Aug 23;193(33):E1289-E1299. doi: 10.1503/cmaj.202887.
citation: Schnegg D, Senn N, Bugnon O, Schwarz J, Mueller Y. Drug Prescription in Older Swiss Men and Women Followed in Family Medicine. Drugs Real World Outcomes. 2020 Mar;7(1):87-95. doi: 10.1007/s40801-019-00175-6.