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

NCT ID: NCT02618291

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 429 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-01-31

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.

Conditions

Geriatric Syndrome; Functional Ability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active Geriatric Evaluation (AGE tool)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Active geriatric evaluation

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne

OTHER

Sponsor Role: lead

Responsible Party

Nicolas Senn

Head of research and de development centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolas Senn, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of community medicine and ambulatory care, University of Lausanne

Locations

Department of Ambulatory Care and Community Medicine

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 34426445 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31845213 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

32003B_159863/1

Identifier Type: -

Identifier Source: org_study_id