title: Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Despite the availability of guidelines for the specific treatment of hereditary angioedema (HAE) attacks, HAE morbidity and mortality rates remain substantial. HAE attacks are a major medical issue requiring specific treatment as well as a considerable socio-economic burden. We report a protocol designed to test whether a dedicated call centre is more effective than usual practice in the management of patients experiencing an HAE attack.
  
  
  METHODS
  This prospective, cluster-randomised, single-blind, parallel-group, multicentre trial evaluates the morbidity and consequent socio-economic costs of the management of patients experiencing an HAE attack by a dedicated call centre as compared to usual practice. The trial aims to recruit 200 patients. Patients in the intervention arm are provided with an SOS-HAE card with the call centre's freephone number that they can access in the case of an attack. The centre's mission is to provide recommended expert advice on early home treatment. The centre can route the call to a local emergency medical service with competency in HAE management or even arrange for the drugs needed for the specific treatment of an HAE attack to be sent to the emergency department of the local hospital. The primary outcome measure is the number of hospital admissions for an HAE attack. Each patient will be followed up every 2 months for 2 years. The study has been approved by the ethics committee (Comité de Protection des Personnes d'Ile de France 10; registration number: 2012-A00044-39; date of approval: 19 January 2012).
  
  
  CONCLUSIONS
  The SOS-HAE protocol has been designed to address the handling of attacks experienced by patients with HAE in the home. The proposed trial will determine whether the setting up of a dedicated call centre is more effective than usual practice in terms of reducing morbidity as given by the numbers of hospital admissions. The results are also anticipated to have important implications in terms of socio-economic costs for both healthcare services and patients.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01679912 .
authors.affiliation: Service des Urgences, Hôpital Louis Mourier, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Assistance Publique - Hôpitaux de Paris, Université Paris 7, 178 Rue des Renouillers, 92 700, Colombes, France. nicolas.javaud@aphp.fr.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Javaud
authors.affiliation: Service de Médecine Interne, DHUi2B, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Assistance Publique - Hôpitaux de Paris, Hôpital Saint-Antoine, Université Paris 6, 75 012, Paris, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Fain
authors.affiliation: URCEco Ile de France, Assistance Publique - Hôpitaux de Paris, Hôpital de l'Hôtel-Dieu, Université Paris 12, 75 004, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Durand-Zaleski
authors.affiliation: Service de Médecine Interne, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Université de Lille, CHRU de Lille, 59037, Lille, Cedex, France.
authors.forename: David
authors.initials: D
authors.lastname: Launay
authors.affiliation: Service de Médecine Interne, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), CHU de Grenoble, 38043, Grenoble, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Bouillet
authors.affiliation: Département d'Endocrinologie Gynécologique, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Assistance Publique - Hôpitaux de Paris, Hôpital Port Royal, Université Paris 5, 75001, Paris, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Gompel
authors.affiliation: T2i, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Assistance Publique - Hôpitaux de Paris, Hôpital Hôtel Dieu, Université Paris 5, 75004, Paris, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Sobel
authors.affiliation: SAMU-SMUR 93, Assistance Publique - Hôpitaux de Paris, Hôpital Avicenne, Université Paris 13, 93 000, Bobigny, France.
authors.forename: Maguy
authors.initials: M
authors.lastname: Woimant
authors.affiliation: URCEco Ile de France, Assistance Publique - Hôpitaux de Paris, Hôpital de l'Hôtel-Dieu, Université Paris 12, 75 004, Paris, France.
authors.forename: Hasina
authors.initials: H
authors.lastname: Rabetrano
authors.affiliation: SAMU-SMUR 93, Assistance Publique - Hôpitaux de Paris, Hôpital Avicenne, Université Paris 13, 93 000, Bobigny, France.
authors.forename: Tomislav
authors.initials: T
authors.lastname: Petrovic
authors.affiliation: SAMU-SMUR 93, Assistance Publique - Hôpitaux de Paris, Hôpital Avicenne, Université Paris 13, 93 000, Bobigny, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Lapostolle
authors.affiliation: Service de Médecine Interne, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), CHU de Grenoble, 38043, Grenoble, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boccon-Gibod
authors.affiliation: SAMU-SMUR 93, Assistance Publique - Hôpitaux de Paris, Hôpital Avicenne, Université Paris 13, 93 000, Bobigny, France.
authors.forename: Paul-Georges
authors.initials: PG
authors.lastname: Reuter
authors.affiliation: SAMU-SMUR 93, Assistance Publique - Hôpitaux de Paris, Hôpital Avicenne, Université Paris 13, 93 000, Bobigny, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Bertrand
authors.affiliation: Service de Médecine Interne, et, 69 437, Lyon, Cedex, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Coppere
authors.affiliation: Service de Réanimation, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), CHU Edouard Herriot, 69 437, Lyon, Cedex, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Floccard
authors.affiliation: Service de Médecine Interne, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), CHU de Nancy, 54 035, Nancy, France.
authors.forename: Gisele
authors.initials: G
authors.lastname: Kanny
authors.affiliation: Service de Dermatologie, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Université d'Angers, CHU d'Angers, 49 933, Angers, Cedex, France.
authors.forename: Ludovic
authors.initials: L
authors.lastname: Martin
authors.affiliation: Unité de Recherche Clinique, Assistance Publique - Hôpitaux de Paris, Hôpital Fernand Widal, Université Paris 7, 75 010, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Vicaut
authors.affiliation: SAMU-SMUR 93, Assistance Publique - Hôpitaux de Paris, Hôpital Avicenne, Université Paris 13, 93 000, Bobigny, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Adnet
mesh_terms: D054179:Angioedemas, Hereditary / Q000175:diagnosis / Q000191:economics / Q000628:therapy*; D000070456:Call Centers / Q000191:economics; D017281:Cost of Illness; D019033:Delivery of Health Care, Integrated / Q000191:economics; D004632:Emergency Medical Services; D005602:France; D017048:Health Care Costs; D005102:Health Expenditures; D006297:Health Services Accessibility / Q000191:economics; D006699:Home Care Services; D006801:Humans; D010343:Patient Admission; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Call centre; Emergency; Hereditary angioedema; Icatibant; Plasma-derived C1 inhibitor