Clinical trial NCT04132544: Risk Factors for Falls After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home
Official title: Impact of an Assessment of Risk Factors for Falls and Personalized Care, on Mortality and Institutionalization, After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: risks factors
Fall Patients
elderly
Urgent Medical Assistance Service
Emergency Care
911
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 952
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional multicenter and open, randomized study in parallel groups comparing two arms
Primary purpose: OTHER

Brief summary: In this project, the investigators are interested in a particular population, that of elderly subjects who used the SAMU after a fall and who are not hospitalized or are hospitalized less than 24 hours. The scientific literature concerning this population is poor . However, this is a particularly vulnerable population. The Direction of research, studies, evaluation and statistics (DREES) report notes that in 2005 in metropolitan France, 24% of people aged 65 to 75 said they had fallen in the last 12 months. Home falls among seniors may require emergency medical services (EMS).

Detailed description: The first cause of accidental death in people over 65, the fall often has a pejorative impact on the physical, psychological and quality of life . It is also predictive of entry into an institution.

In this project, the investigators propose to evaluate the patient at home with a Gerontological Assessment Nurse working in collaboration with the attending physician, whenever the fall triggers a call to the SAMU (without hospitalization or with hospitalization of less than 24 hours). In addition to the evaluation, the nurse will propose a personalized intervention plan (PIP) based on targeted and prioritized actions.

The Main objective is to study the effect of a personalized intervention plan (PIP) proposed by a Gerontological Assessment Nurse at home in the elderly who used the SAMU for a fall (with on-site care or hospitalization inferior to 24h), on the delay institutionalization or death before institutionalization compared to standard care.

Eligibility criteria: Inclusion Criteria:

* Living at home
* Living at maximum 45 minutes from a hospital center participating in the study (for logistical reasons and practices of study organization)
* Intervention of the SAMU for a fall at home without there being hospitalization or with hospitalization lasting less than 24h
* Patient or trusted person capable of giving telephone information
* Patient or his / her trusted person who has agreed to participate in the study
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Total dependency (ADL at 0)
* Entry in nursing home already scheduled within 3 months

Primary outcomes:
measure: The delay between the T0 and Time of occurrence
timeFrame: 2 years
Secondary outcomes:
measure: Number of reminders to the SAMU for fall
timeFrame: 2 years
measure: Number of non-programmed hospitalizations
timeFrame: 2 years
measure: Evolution of the dependence level evaluated by the ADL scale
timeFrame: 2 years
measure: Evolution of the quality-of-life score evaluated by Short Form -12
timeFrame: 2 years
measure: Number of deceased or institutionalized subjects
timeFrame: 2 years
Other outcomes:
Locations:
city: Albi
country: France
facility: CH Albi
city: Cahors
country: France
facility: CH Cahors
city: Castres
country: France
facility: CH Castres-Mazamet
city: Foix
country: France
facility: CHIVA
city: Lannemezan
country: France
facility: CH Lannemezan
city: Lavaur
country: France
facility: CH Lavaur
city: Montauban
country: France
facility: CH Montauban
city: Rodez
country: France
facility: CH Rodez
city: Saint-Girons
country: France
facility: CH Ariège Couserans
city: Tarbes
country: France
facility: CH Bigorre
city: Toulouse
country: France
facility: University Hospital Toulouse
city: Vic-Fezensac
country: France
facility: Maison de Santé Pluri-professionnelle
Study officials:
affiliation: University Hospital, Toulouse
name: Fati Nourhashemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouzid W, Tavassoli N, Berbon C, Qassemi S, Bounes V, Azema O, Shourick J, Nourhashemi F. Impact of a personalised care plan for the elderly calling emergency medical services after a fall at home: The RISING-DOM multi-centre randomised controlled trial protocol. BMC Geriatr. 2022 Mar 4;22(1):182. doi: 10.1186/s12877-022-02850-w.
citation: Ailliaud A, Moulis E, Vaysset S, Berbon C, Tavassoli N, Bouzid W, Oliveira Soares C, Qassemi S, Nourashemi F. [Assessment in the home of the elderly following a first fall with Samu intervention]. Soins Gerontol. 2022 Jan-Feb;27(153):23-25. doi: 10.1016/j.sger.2021.11.008. Epub 2021 Nov 24. French.