The Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Patients Calling for Primary Care

Gastroenteritis Symptoms Clinical Trial

— CMTp  

Official title:

Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Primary Care: the Formalised Telephone Medical Advice Study, a Cluster Randomised Control Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286245
• Other study ID #: K120104
• Secondary ID: 2013-AO1722-43
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: January 10, 2017
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Telephone medical advice in general practice is expanding. The Cochrane Database concludes in 2008 that there is not enough data about its use regarding out-of-hours general practitioners workload, emergency department visits, cost, safety and patient satisfaction. The aim of this study is to assess the effectiveness of telephone medical advice given by a general practitioner in a call centre for patient presenting isolated fever or gastroenteritis symptoms.

Description:

This is a prospective, open label, cluster randomized trial of 2 880 expected patients who calling a French emergency medical service Dial 15 for fever or gastroenteritis symptoms during out-of-hours periods. All calls will be taken by a general practitioner (GP). Out-of-hours period is defined as 8 PM to 8 AM on weekdays, 1 PM to 8PM on Saturdays in addition to Sundays and holidays.To be exhaustive, we will enrol patients during one year.

In the experimental arm, the GP will implement a protocol of care to each patient call. The protocol includes medical advice, drug prescription by phone and supervisory board. Patients are invited to recall in case of worsening or onset of new symptoms and to get an appointment with their GP during working hours.

In the non-interventional arm, the GP will decide the need of telephone advice with or without drug prescription, home visit by a doctor, emergency department services with or without EMS system.

We will recall every patient at 15+/-4 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2498
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Disease:

• Fever: temperature = 38 ° C

• Symptoms of gastroenteritis include nausea and / or vomiting and / or diarrhea

• Onset of symptoms for less than 72 hours

• Age = 18 years caller

• Patient age = 1 year

• Affiliation to the French National Health Service

Exclusion Criteria:

• Pregnancy

• Severity criteria (fever> 41 ° C, disturbance of consciousness, rash, dyspnea, signs of dehydration, chest pain, neurological signs, gastrointestinal bleeding)

• Seeking advice from institutional correspondents (fire brigade, police, airport…)

• Communication difficulties (non-communicating patient, language barrier...)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroenteritis
• Gastroenteritis Symptoms
• Isolated Fever

Intervention

Other:
• focused Telephonic Medical Advice
The physician will implement a protocol of care to each patient call for an isolated fever and/or symptoms of gastroenteritis: medical advice, drug prescription by phone and supervisory board
• Usual practice
The physician will decide for the same disease (isolated fever and/or symptoms of gastroenteritis) the need of telephone advice with or without drug prescription, home visit by a doctor, emergency department services with or without EMS system.

Locations

Country	Name	City	State
France	SAMU 93 - EA 3409 - Faculté de Médecine de Bobigny - Université Paris 13	Bobigny	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods	Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods	at 15 days	No
Secondary	Cost effectiveness	Cost effectiveness based on the economic analysis in each arm (sick leaves, hospitalization, EMS or firemen use...)	at 15 days	No
Secondary	Care Mobile Units use		at 15 days	Yes
Secondary	Emergency Medical Service use		at 15 days	No
Secondary	Firemen use	Number of fireman use	at 15 days	No
Secondary	Recall at dispatching centre		at 15 days	No
Secondary	Number and length of sick leave		at 15 days	No
Secondary	All causes mortality		at 15 days	Yes
Secondary	Morbidity		at 15 days	Yes
Secondary	Patient satisfaction	Patient satisfaction evaluated by a 14 items questionnaire ans a numeric scale from 0 to 10	at 15 days	No
Secondary	Patient adhesion	Percentage of patient's adhesion to the advice and/or drug prescriptions	at 15 days	No
Secondary	Clinical outcome	Percentage of relieved patients	at 15 days	Yes
Secondary	Number of stay in intensive care unit		at 15 days	Yes
Secondary	Number of hospitalisation		at 15 days	Yes
Secondary	Number of patients seen repeatedly		at 15 days	No