Efficacy of an Active Geriatric Evaluation for Geriatric Syndromes to Prevent Functional Decline in Family Medicine

Functional Ability Clinical Trial

— AGE3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618291
• Other study ID #: 32003B_159863/1
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2021
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Ability
• Geriatric Syndrome
• Syndrome

Intervention

Other:
• Active Geriatric Evaluation (AGE tool)
Yearly administration of the brief assessment tool (BAT). Once the presence of one or more geriatric syndromes is suspected using the brief assessment tool, a management strategy is proposed. It is divided in two distinct steps: 1) perform additional tests to confirm or exclude the diagnosis and 2) to propose specific management attitudes. All proposed attitudes are based on literature review and geriatrician expertise. The FP remains free to follow the proposed attitudes.
• Usual care
No specific intervention will be provided to the patients, except what family practitioners (FPs) usually do. In this regard, it is possible that some FPs might use structured interventions similar to the AGE tool. This will be neither encouraged nor discouraged. FPs in the "usual care" arm will be asked to perform one BAT after 2 years of follow-up, at the final patient visit.

Locations

Country	Name	City	State
Switzerland	Department of Ambulatory Care and Community Medicine	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adhesion to Active Geriatric Evaluation Tool	Proportion of GPs completing the difference sections of the Active Geriatric Evaluation Tool	2 years
Other	Total cost	Comparison, by arm, of total cost, corresponding to the sum of costs billed by FPs, drug prescriptions, hospital and institutional admission costs	2 years
Primary	Instrumental Activities of Daily Living (IADL)	Proportion of patients losing at least 1 instrumental IADL (8 items developed to assess functional status)	2 years
Primary	Basic Activities of Daily Living (ADL)	Proportion of patients losing at least 1 basic ADL (6 items developed to assess functional status)	2 years
Secondary	Incidence of hospital admissions	Number of hospital admissions per patient per year	During 2 years
Secondary	Incidence of institutionalization	Number of institutionalization per patient per year	During 2 years
Secondary	Incidence of emergency visits	Number of emergency visits per patient per year	During 2 years
Secondary	Incidence of outpatient visits	Number of outpatient visits to GP per patient per year	During 2 years
Secondary	Health related quality of life (WHOQOL-OLD) score	questionnaire composed of 24 items. This broadly validated instrument is composed of six facets: 1) Sensory abilities, 2) Autonomy, 3) Past, present and future activities, 4) Social participation, 5) Death and dying and 6) Intimacy	2 years