Risk Factors for Falls After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home

NCT04132544 | Completed

• 1 other identifier: RC31/17/0453
• Study Type: interventional
• Target: 952
• Locations: 1 country
• Sites: 12

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).

Conditions

Elderly

Keywords

risks factors; Fall Patients; elderly; Urgent Medical Assistance Service; Emergency Care; 911

Outcome Measures

Primary Outcomes (1)

• The delay between the T0 and Time of occurrence

  The composite criterion corresponding to the delay between the T0 and the occurrence of an institutionalization or a death before institutionalization (first event occurring). In this pilot study, the average age of subjects was 83.6 years. This is a population for which the goals of home care and delay in the onset of dependence and in the occurrence of death are interesting and feasible.

  2 years

Secondary Outcomes (7)

• Number of reminders to the SAMU for fall

  2 years

• Number of non-programmed hospitalizations

  2 years

• Evolution of the dependence level evaluated by the ADL scale

  2 years

• Evolution of the quality-of-life score evaluated by Short Form -12

  2 years

• Number of deceased or institutionalized subjects

  2 years

Study Arms (2)

Intervention group

EXPERIMENTAL

* a standardized gerontological evaluation (EGS) and a fall balance performed at home or teleconsultation by a Gerontological Assessment Nurse * the proposal for a Proposal for a personalized intervention plan (PIP) to correct potentially reversible and modifiable factors * a close follow-up by the Gerontological Assessment Nurse for the implementation of the PIP throughout the follow-up period of 24 months (6 home visits and 5 telephone follow-ups).

Other: standardized gerontological evaluation (EGS); Other: Proposal for a personalized intervention plan (PIP); Other: Follow-up

Comparison group - usual care

ACTIVE COMPARATOR

Usual Care with the provision of documentation on simple recommendations for the prevention of falls and aging well.

Other: Usual care

Interventions

standardized gerontological evaluation (EGS) OTHER

Evaluation (EGS): initially, the patient benefits from a complete EGS and a complete fall balance realized by a Gerontological Assessment Nurse (initial visit V0) in the 7 working days following the intervention of the SAMU for fall. This assessment is based on the EGS and the assessment of risk factors for falls (HAS, INPES).

Intervention group

Proposal for a personalized intervention plan (PIP) OTHER

A PIP containing personalized recommendations to improve the patient's state of health, treatment and environment as well as risk factors for falls is proposed during the multi-professional consultation and discussed by telephone with the attending physician (pre-arranged telephone appointment). with the latter). The PIP validated by the attending physician is delivered and explained to the patient by the Gerontological Assessment Nurse in the week following the Multidisciplinary Team Meeting (MDTM) during the V1 visit to the patient's home.

Intervention group

Follow-up OTHER

Four follow-up visits at 6, 12, 18 and 24 months (V2, V3, V4, V5) are performed at the patient's home. During these visits, the Gerontological Assessment Nurse reassesses the person from the gerontological point of view and from the point of view of risk factors for falls. A mail containing the elements of interest is sent to the attending physician after each visit. The patient is also contacted by telephone by the Gerontological Assessment Nurse at 2, 4, 9, 15 and 21 months of follow-up to maintain a link, identify possible difficulties and encourage him / her to apply the PIP recommendations.

Intervention group

Usual care OTHER

The patients included in the "control" group will benefit from the usual care as well as documentation on general recommendations to be put in place to prevent falls and to age in good health \[series of brochures published by INPES for the elderly. They are informed by telephone of their home group by the Gerontological Assessment Nurse. The documents are sent by mail to the patient's home address.

Comparison group - usual care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (12)

CH Albi

Albi, France

Location

CH Cahors

Cahors, France

Location

CH Castres-Mazamet

Castres, France

Location

CHIVA

Foix, France

Location

CH Lannemezan

Lannemezan, France

Location

CH Lavaur

Lavaur, France

Location

CH Montauban

Montauban, France

Location

CH Rodez

Rodez, France

Location

CH Ariège Couserans

Saint-Girons, France

Location

CH Bigorre

Tarbes, France

Location

University Hospital Toulouse

Toulouse, 31059, France

Location

Maison de Santé Pluri-professionnelle

Vic-Fezensac, France

Location

Related Publications (3)

• 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.

  PMID: 35246053 RESULT

• Bouzid W, Tavassoli N, Berbon C, Qassemi S, Vaysset S, Poly M, Bounes V, Shourick J, Nourhashemi F. Exploring Population Characteristics and Recruitment Challenges in Older People Experiencing Falls at Home without Hospitalization or with an Emergency Department Visit: Insights from the RISING-DOM Experience. Clin Interv Aging. 2023 Dec 1;18:1995-2008. doi: 10.2147/CIA.S421053. eCollection 2023.

  PMID: 38058551 RESULT

• 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.

  PMID: 35120719 RESULT

Study Officials

• Fati Nourhashemi, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional multicenter and open, randomized study in parallel groups comparing two arms

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: October 1, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: February 2, 2026

Record last verified: 2024-05

Locations

FR (12)