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

Study Overview
=================
Brief 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.

Detailed 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.

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.

Conditions
-----------------
Isolated Fever, Gastroenteritis Symptoms

Intervention / Treatment
-----------------
* Other: focused Telephonic Medical Advice
* Other: Usual practice


Participation Criteria
=================
Eligibility Criteria
-----------------
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...)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: focused Telephonic Medical Advice<br>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. Patients are invited to recall in case of worsening or onset of new symptoms and to get an appointment with their general practitioner during working hours. | Other: focused Telephonic Medical Advice<br>* 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<br>|
| Active Comparator: 2: Usual practice<br>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. | Other: Usual practice<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness | Cost effectiveness based on the economic analysis in each arm (sick leaves, hospitalization, EMS or firemen use...) | at 15 days | 
| Care Mobile Units use |  | at 15 days | 
| Emergency Medical Service use |  | at 15 days | 
| Firemen use | Number of fireman use | at 15 days | 
| Recall at dispatching centre |  | at 15 days | 
| Number and length of sick leave |  | at 15 days | 
| All causes mortality |  | at 15 days | 
| Morbidity |  | at 15 days | 
| Patient satisfaction | Patient satisfaction evaluated by a 14 items questionnaire ans a numeric scale from 0 to 10 | at 15 days | 
| Patient adhesion | Percentage of patient's adhesion to the advice and/or drug prescriptions | at 15 days | 
| Clinical outcome | Percentage of relieved patients | at 15 days | 
| Number of stay in intensive care unit |  | at 15 days | 
| Number of hospitalisation |  | at 15 days | 
| Number of patients seen repeatedly |  | at 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Triage, Hotline, Primary Health Care, Emergency Medical Service Communication Systems