title: 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.
abstract: BACKGROUND
  Telephone consultations in general practice are on the increase. However, data on their efficiency in terms of out-of-hours general practitioner (GP) workload, visits to hospital emergency departments (ED), cost, patient safety and satisfaction are relatively scant. The aim of this trial is to assess the effectiveness of telephone consultations provided by French emergency call centres in patients presenting with isolated fever or symptoms of gastroenteritis, mainly encountered diseases.
  
  
  METHODS
  This is a prospective, open-label, multicentre, pragmatic, cluster randomised clinical trial of an estimated 2880 patients making an out-of-hours call to one of six French emergency call centres for assistance with either fever or symptoms of gastroenteritis without seriousness criteria. Each call is handled by a call centre physician. Out-of-hours is 8 p.m. to 7.59 a.m. on weekdays, 1 p.m. to 7.59 a.m. on Saturdays and round-the-clock on Sundays and school holidays. Patients will be enrolled over 1 year. In the intervention arm, a telephone consultation based on a protocol, the formal Telephone Medical Advice (fTMA), is offered to each patient calling. This protocol aims to overcome a physical consultation during out-of-hours periods. It offers reassurance and explanations, advice on therapeutic management which may include, in addition to hygiene and diet measures, a telephone prescription of antipyretic, analgesic, rehydration medication or others, and recommendations on surveillance of the patient and any action to be taken. The patient is invited to call again if the condition worsens or new symptoms develop and to make an appointment with their family GP during office hours. In the control arm, the call centre physician handles calls as usual. This physician can carry out a telephone consultation with or without a telephone prescription, dispatch an on-duty GP, the fire brigade or an ambulance to the patient, or refer the patient to an on-duty physician or to the ED. Each patient will receive a follow-up call on day 15. The primary endpoint is the frequency of out-of-hours, face-to-face GP consultations or visits to the ED during the 15 days following the index call. The secondary endpoints measured on day 15 are the number of stays in intensive care, the number of hospital admissions, the number of interventions by the fire brigade, emergency medical and ambulance services, the number and length of prescribed sick-leave episodes, all-cause mortality, morbidity, clinical outcome, patient compliance, patient satisfaction, the number of renewed calls to the call centre, the number of patients receiving multiple face-to-face GP consultations and costs incurred.
  
  
  CONCLUSIONS
  This trial will assess the effectiveness and the cost-effectiveness of a formalised response to calls for assistance with fever or symptoms of gastroenteritis without seriousness criteria.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02286245 , registered on 9 September 2014.
authors.affiliation: Service des Urgences et Service d'Aide Médicale Urgente, Centre Hospitalier Universitaire Avicenne, Assistance Publique-Hôpitaux de Paris, 125 rue de Stalingrad, 93009, Bobigny Cedex, France. paul-georges.reuter@aphp.fr.|Université Paris 13, Sorbonne Paris Cité, EA 3509, Bobigny, France. paul-georges.reuter@aphp.fr.
authors.forename: Paul-Georges
authors.identifier: http://orcid.org/0000-0001-9022-5876
authors.initials: PG
authors.lastname: Reuter
authors.affiliation: Urgences et SAMU 25 - Centre Hospitalier Régional Universitaire de Besançon, 1 Bd Fleming, 25030, Besançon Cedex, France.|Université de Franche Comté-Bourgogne, UMR 6249 CNRS/UFC, 1 Bd Fleming, 25030, Besançon Cedex, France.
authors.forename: Thibaut
authors.initials: T
authors.lastname: Desmettre
authors.affiliation: Service des Urgences et Service d'Aide Médicale Urgente, Centre Hospitalier Universitaire Avicenne, Assistance Publique-Hôpitaux de Paris, 125 rue de Stalingrad, 93009, Bobigny Cedex, France.|Université Paris 13, Sorbonne Paris Cité, EA 3509, Bobigny, France.
authors.forename: Sabine
authors.initials: S
authors.lastname: Guinemer
authors.affiliation: SAMU-SMUR 95, Centre Hospitalier René Dubos, 6 Avenue de l'Île de France, 95300, Pontoise, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Ducros
authors.affiliation: Association COmtoise de REgulation Libérale, CHRU de Besançon, 1 Bd Fleming, 25030, Besançon Cedex, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Begey
authors.affiliation: SAMU-SMUR 95, Centre Hospitalier René Dubos, 6 Avenue de l'Île de France, 95300, Pontoise, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Ricard-Hibon
authors.affiliation: SAMU 44, PHU Urgences - Médecines - Soins Critiques, Centre Hospitalo-Universitaire de Nantes, 1 quai Moncousu, 44 093, Nantes Cedex, France.
authors.forename: Laurianne
authors.initials: L
authors.lastname: Billier
authors.affiliation: SAMU 44, PHU Urgences - Médecines - Soins Critiques, Centre Hospitalo-Universitaire de Nantes, 1 quai Moncousu, 44 093, Nantes Cedex, France.
authors.forename: Océane
authors.initials: O
authors.lastname: Grignon
authors.affiliation: SAMU SMUR Urgences, Centre Hospitalier Châteauroux, 216 avenue de Verdun, 36000, Châteauroux, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Megy-Michoux
authors.affiliation: SAMU SMUR Urgences, Centre Hospitalier Châteauroux, 216 avenue de Verdun, 36000, Châteauroux, France.
authors.forename: Jean-Noël
authors.initials: JN
authors.lastname: Latouff
authors.affiliation: SAMU 82, Centre Hospitalier de Montauban, 100 rue Léon Vladel, 82000, Montauban, France.
authors.forename: Adeline
authors.initials: A
authors.lastname: Sourbes
authors.affiliation: SAMU 82, Centre Hospitalier de Montauban, 100 rue Léon Vladel, 82000, Montauban, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Latier
authors.affiliation: Assistance Publique-Hôpitaux de Paris, URC Eco, Paris, France.|Inserm, ECEVE, U1123, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Durand-Zaleski
authors.affiliation: Service des Urgences et Service d'Aide Médicale Urgente, Centre Hospitalier Universitaire Avicenne, Assistance Publique-Hôpitaux de Paris, 125 rue de Stalingrad, 93009, Bobigny Cedex, France.|Université Paris 13, Sorbonne Paris Cité, EA 3509, Bobigny, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Lapostolle
authors.affiliation: Unité de Recherche Clinique, Saint Louis - Lariboisière - Fernand Widal University Hospital, AP-HP, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Vicaut
authors.affiliation: Service des Urgences et Service d'Aide Médicale Urgente, Centre Hospitalier Universitaire Avicenne, Assistance Publique-Hôpitaux de Paris, 125 rue de Stalingrad, 93009, Bobigny Cedex, France.|Université Paris 13, Sorbonne Paris Cité, EA 3509, Bobigny, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Adnet
keywords: Cluster randomised controlled trial; Compliance; Cost-effectiveness; Fever; Gastroenteritis; Primary care; Satisfaction; Telephone consultation