Clinical trial NCT02087982: Development of General Practitioners Screening Tool of Frail Older Old Community
Official title: Development of General Practitioners Screening Tool of Frail Older Old Community-dwellers: a Cohort Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aged (80 or More)
Healthy
Lead sponsor: Gerontopôle des Pays de la Loire
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
First posted: 2014-03-14
Enrollment: 840
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults aged 80 and over

Brief summary: The comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary diagnostic process to determine the medical, psychological, and functional capabilities of an elderly person, in order to develop a coordinated and integrated plan for treatment. It represents the first stage of the most appropriate care for elderly people who are frail or who cannot perform at least three daily tasks unaided.

It has been shown that the integration of CGA in the decision-making and care management at hospital improves inpatient's health and functional status, and reduces mortality rate and healthcare expenditures. The effects of CGA in daily practice of general practitioners remain unknown.

Implementation of a systematic CGA for every older old community-dwellers performed by a general practitioner remains yet difficult because of number of issues. First, although the number of older old community-dwellers keeps increasing, the number of health care professional with geriatric skills does not. Second, CGA is a complex and time-consuming process. Third, CGA requires a multidisciplinary geriatric team that cannot support alone the care of all frail older old community-dwellers due to their limited number. An implication of non-geriatricians in CGA is therefore required.

Recently, it was confirmed that CGA cannot be applied to all older adults, and that the best compromise could be the use of a two-step approach. The first step is the identification by non-geriatricians of elderly inpatients at high risk of adverse outcomes using a screening tool, and the second step is a CGA by geriatricians with a diagnosis purpose.

None of existing tools used for screening is adapted to the population of elderly people who visit general practitioners.Thus, healthcare professionals working in ED need a simple, standardized and brief geriatric assessment (BGA) to identify as soon as possible frail older old community-dwellers requiring specialized geriatric care.

The investigators hypothesized that a BGA older old community-dwellers carried out by a general practitioner could predict the adverse health events (i.e. hospitalization, institutionalisation, medical consultations and death) occurring during a 6-months follow-up period before the evaluation.


Eligibility criteria: Inclusion Criteria:

Eligible patients are those who meet the following inclusion criteria:

* the patient is aged 80 or more,
* the patient comes to a normal medical consultation without any acute health problem,
* the patient lives at home,
* the patient is able to respond to questions he is asked,
* the patient has given his agreement to answer questions during the initial consultation, to answer further questions by telephone after 3 months and to return in 6 months for a further consultation,
* the life expectancy of the patient as estimated by the primary care practitioner is greater than 6 months.
* the patient has french nationality and is a member of a national Social Security scheme.

Exclusion Criteria:

Patients are ineligible if :

* one inclusion criteria is not met,
* if a close relation of the patient does not agree the patient to be part of the study.

Primary outcomes:
measure: Number of non planned hospitalization by subjects
timeFrame: Hospitalization between inclusion and follow up to 6 months
Secondary outcomes:
measure: Number of subjects' institutionnalized
timeFrame: Institutionnalization between inclusion and follow up at 3 or 6 months
measure: Number of dead subjects
timeFrame: Death between inclusion and follow up at 3 or 6 months
Other outcomes:
measure: Number of non planned consultations by subjects
timeFrame: Number of non planned consultations between inclusion and follow up at 3 or 6 months
Locations:
city: Leers
country: France
facility: Nord Pas de Calais
Study officials:
affiliation: Nantes University Hospital
name: Gilles Berrut, PhD
role: PRINCIPAL_INVESTIGATOR
References: