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Completed

NCT Number: NCT02618291

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

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ambulatory Care and Community Medicine

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Geriatric Evaluation (AGE tool)

Other

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.

Other names: Active geriatric evaluation

Usual Care

Other

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.

Primary outcomes

  1. Instrumental Activities of Daily Living (IADL)

    Time frame: 2 years

    Proportion of patients losing at least 1 instrumental IADL (8 items developed to assess functional status)

  2. Basic Activities of Daily Living (ADL)

    Time frame: 2 years

    Proportion of patients losing at least 1 basic ADL (6 items developed to assess functional status)

Secondary outcomes

  1. Incidence of hospital admissions

    Time frame: During 2 years

    Number of hospital admissions per patient per year

  2. Incidence of institutionalization

    Time frame: During 2 years

    Number of institutionalization per patient per year

  3. Incidence of emergency visits

    Time frame: During 2 years

    Number of emergency visits per patient per year

  4. Incidence of outpatient visits

    Time frame: During 2 years

    Number of outpatient visits to GP per patient per year

  5. Health related quality of life (WHOQOL-OLD) score

    Time frame: 2 years

    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

Other outcomes

  1. Adhesion to Active Geriatric Evaluation Tool

    Time frame: 2 years

    Proportion of GPs completing the difference sections of the Active Geriatric Evaluation Tool

  2. Total cost

    Time frame: 2 years

    Comparison, by arm, of total cost, corresponding to the sum of costs billed by FPs, drug prescriptions, hospital and institutional admission costs

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Registry information

Official study 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

Acronym: AGE3

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 1, 2015
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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