- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02712450
Tools Development for Geriatric Emergency Regulation (REGESA)
Tools Development for Geriatric Emergency Regulation at the Emergency Service Centre, in the Rhône Area
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69003
- Service Gériatrie - Hôpital Edouard Herriot, Hospices Civils de Lyon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control group
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Experimental group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of patients sent to an emergency department
Time Frame: 24 hours after patient's call
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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.
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24 hours after patient's call
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Duration of the hospital stay in emergency department
Time Frame: 7 days after patient's call
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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.
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7 days after patient's call
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Occurence of non-programmed hospitalization in emergency department
Time Frame: 7 days after patient's call
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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
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7 days after patient's call
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Geriatric channel utilisation rate
Time Frame: 24 hours after patient's call
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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
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24 hours after patient's call
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Training course feasibility
Time Frame: 24 hours after patient's call
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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)
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24 hours after patient's call
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Medical cost for patient
Time Frame: 7 days after patient's call
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7 days after patient's call
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Non medical cost for patient
Time Frame: 7 days after patient's call
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7 days after patient's call
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Training course cost
Time Frame: 7 days after patient's call
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7 days after patient's call
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL14_0449
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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