Clinical trial NCT02286245: The Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Patients Calling for Primary Care
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Isolated Fever
Gastroenteritis Symptoms
Keywords: Triage
Hotline
Primary Health Care
Emergency Medical Service Communication Systems
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 2498
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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...)

Primary outcomes:
measure: Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods
timeFrame: at 15 days
Secondary outcomes:
measure: Cost effectiveness
timeFrame: at 15 days
measure: Care Mobile Units use
timeFrame: at 15 days
measure: Emergency Medical Service use
timeFrame: at 15 days
measure: Firemen use
timeFrame: at 15 days
measure: Recall at dispatching centre
timeFrame: at 15 days
measure: Number and length of sick leave
timeFrame: at 15 days
measure: All causes mortality
timeFrame: at 15 days
measure: Morbidity
timeFrame: at 15 days
measure: Patient satisfaction
timeFrame: at 15 days
measure: Patient adhesion
timeFrame: at 15 days
measure: Clinical outcome
timeFrame: at 15 days
measure: Number of stay in intensive care unit
timeFrame: at 15 days
measure: Number of hospitalisation
timeFrame: at 15 days
measure: Number of patients seen repeatedly
timeFrame: at 15 days
Other outcomes:
Locations:
city: Bobigny
country: France
facility: SAMU 93 - EA 3409 - Faculté de Médecine de Bobigny - Université Paris 13
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frédéric ADNET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reuter PG, Durand-Zaleski I, Ducros O, Grignon O, Megy-Michoux I, Sourbes A, Desmettre T, Javaud N, Lapostolle F, Vicaut E, Adnet F. Efficacy of emergency medical center use of a protocol during telephone calls to give medical advice related to fever or gastroenteritis: a cluster randomized controlled trial. Emergencias. 2021 Aug;33(4):292-298. English, Spanish.
citation: Reuter PG, Desmettre T, Guinemer S, Ducros O, Begey S, Ricard-Hibon A, Billier L, Grignon O, Megy-Michoux I, Latouff JN, Sourbes A, Latier J, Durand-Zaleski I, Lapostolle F, Vicaut E, Adnet F. Effectiveness and cost-effectiveness of telephone consultations for fever or gastroenteritis using a formalised procedure in general practice: study protocol of a cluster randomised controlled trial. Trials. 2016 Sep 22;17(1):461. doi: 10.1186/s13063-016-1585-9.