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Efficacy of an Active Geriatric Evaluation for Geriatric Syndromes to Prevent Functional Decline in Family Medicine (AGE3)

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ClinicalTrials.gov Identifier: NCT02618291
Recruitment Status : Active, not recruiting
First Posted : December 1, 2015
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Nicolas Senn, University of Lausanne

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.

Condition or disease Intervention/treatment Phase
Geriatric Syndrome Functional Ability Other: Active Geriatric Evaluation (AGE tool) Other: Usual care Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Active Geriatric Evaluation (AGE tool)
The Active Geriatric Evaluation is a comprehensive assessment and management tool consisting of a 20-minute clinical screening instrument (Brief Assessment Tool, BAT) to identify 8 geriatric syndromes, and complementary diagnostic evaluations and propositions of management & treatment for each syndrome.
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.
Other Name: Active geriatric evaluation

Active Comparator: 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.
Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618291


Locations
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Switzerland
Department of Ambulatory Care and Community Medicine
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne
Investigators
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Principal Investigator: Nicolas Senn, MD PhD Department of community medicine and ambulatory care, University of Lausanne
  Study Documents (Full-Text)

Documents provided by Nicolas Senn, University of Lausanne:
Statistical Analysis Plan  [PDF] November 29, 2018
Study Protocol  [PDF] December 19, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nicolas Senn, Head of research and de development centre, University of Lausanne
ClinicalTrials.gov Identifier: NCT02618291    
Other Study ID Numbers: 32003B_159863/1
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Keywords provided by Nicolas Senn, University of Lausanne:
primary health care
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes