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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02712450
Other study ID # 69HCL14_0449
Secondary ID
Status Completed
Phase N/A
First received February 16, 2016
Last updated February 23, 2018
Start date January 2016
Est. completion date August 2017

Study information

Verified date February 2018
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

According to surveys, 13% to 20% of the Service Médical d'Urgence (SAMU) centre 15 (French 911) calls concern elderly patients above 75 years of age. For these patients, the clinical pathway should be decided on the basis of the symptomatology described during the call, but also with the gathering of specific data such as medical social and psychological evaluation. These items allow the regulating doctor to assess comorbidity, on-going treatment, psycho-cognitive status, previous hospitalisations, social situation, and patient expectations and needs.

However, data collected in order to assess the situation on the phone and take the orientation decision are mainly limited to the severity of clinical symptoms. Medical, psychological and social aspects are rarely gathered, for several reasons :

- Phone call shortness : emergency calls should be treated quickly

- Regulating doctors are not trained to take in account the specificities or geriatric patients in their decision making. Besides, they are not informed about alternatives to the hospital emergency department, such as "geriatric channel" system.

An observational study was performed in 2012 on 692 calls about elderly patients referred to the SAMU centre 15 during 7 days : 63% of these patients were transferred to an emergency department. Regardless of severe cases "hospital regulation", 55% of the least serious cases ("liberal regulation") were transferred to an emergency department.

Regulation is inadequate to elderly patients for whom 1) the situation assessment and the appropriate decision making require specific items that are not known by regulating doctors, 2) the medical care and the clinical pathway could be improved by the knowledge of on-field "geriatric channel", 3) the emergency department care is particularly long, 4) and could be pernicious to younger patients.

1920 patients will be recruited between January 2016 and August 2017, including a 6 months wash-out in order to train regulating doctors. This training will include geriatric patient's specificities, and geriatric channels. A 12% difference between the 2 groups (before and after the training) is expected, considering a 80% statistical power. The design is a time series experiment.


Recruitment information / eligibility

Status Completed
Enrollment 2279
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria:

- Patient above 75 years olds

- Patient calling for a liberal regulation

- Patient calling between 8 a.m. and 6 p.m. from monday to friday

Exclusion Criteria:

- Patient calling for vital emergency (hospital regulation)

- Patient calling for inter-hospital transport

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service Gériatrie - Hôpital Edouard Herriot, Hospices Civils de Lyon Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients sent to an emergency department The training course efficiency (which contains specific regulation tools and emergency regulation doctors formation) will be assessed by evaluating the proportion of 75 years old patients and older sent to an emergency department after a liberal regulation. 24 hours after patient's call
Secondary Duration of the hospital stay in emergency department The training course efficiency on hospital stay duration will be assessed by evaluating the duration of the hospital stay in emergency department, after regulating doctor decision. 7 days after patient's call
Secondary Occurence of non-programmed hospitalization in emergency department The training course efficiency on non-programmed hospitalization in emergency department will be assessed by evaluating the occurence of these type of hospitalization one week after call regulation 7 days after patient's call
Secondary Geriatric channel utilisation rate Training course efficiency on the geriatric channel utilization by regulating doctors will be assessed using multiple parameters : geriatric hotline use, intra-hospital geriatric mobile team mobilisation, extra-hospital geriatric mobile team mobilisation, direct hospitalization in geriatric department 24 hours after patient's call
Secondary Training course feasibility Training course feasibility will be assessed using multiple parameters : regulation call duration, regulating doctor orientation respect, contact between regulating doctor and physician (GP, geriatric doctor, emergency doctor, geriatric channel) 24 hours after patient's call
Secondary Medical cost for patient 7 days after patient's call
Secondary Non medical cost for patient 7 days after patient's call
Secondary Training course cost 7 days after patient's call