Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-04-30

AUTHORS

Nicolas Javaud, Olivier Fain, Isabelle Durand-Zaleski, David Launay, Laurence Bouillet, Anne Gompel, Alain Sobel, Maguy Woimant, Hasina Rabetrano, Tomislav Petrovic, Frédéric Lapostolle, Isabelle Boccon-Gibod, Paul-Georges Reuter, Philippe Bertrand, Brigitte Coppere, Bernard Floccard, Gisele Kanny, Ludovic Martin, Eric Vicaut, Frédéric Adnet

ABSTRACT

BackgroundDespite 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/designThis 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).DiscussionThe 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.Trial registrationClinicalTrials.gov NCT01679912. More... »

PAGES

225

References to SciGraph publications

  • 2010-07-28. HAE international home therapy consensus document in ALLERGY, ASTHMA & CLINICAL IMMUNOLOGY
  • 2006-02-08. Symptoms, Course, and Complications of Abdominal Attacks in Hereditary Angioedema Due to C1 Inhibitor Deficiency in THE AMERICAN JOURNAL OF GASTROENTEROLOGY
  • 2011-04-12. One hypovolaemic shock…two kinin pathway abnormalities in INTENSIVE CARE MEDICINE
  • Journal

    TITLE

    Trials

    ISSUE

    1

    VOLUME

    17

    Author Affiliations

  • 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
  • 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
  • URCEco Ile de France, Assistance Publique - Hôpitaux de Paris, Hôpital de l’Hôtel-Dieu, Université Paris 12, 75 004, Paris, France
  • Service de Médecine Interne, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Université de Lille, CHRU de Lille, 59037, Lille, Cedex, France
  • Service de Médecine Interne, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), CHU de Grenoble, 38043, Grenoble, France
  • 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
  • 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
  • SAMU-SMUR 93, Assistance Publique - Hôpitaux de Paris, Hôpital Avicenne, Université Paris 13, 93 000, Bobigny, France
  • Service de Médecine Interne, et, 69 437, Lyon, Cedex, France
  • Service de Réanimation, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), CHU Edouard Herriot, 69 437, Lyon, Cedex, France
  • Service de Médecine Interne, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), CHU de Nancy, 54 035, Nancy, France
  • Service de Dermatologie, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Université d’Angers, CHU d’Angers, 49 933, Angers, Cedex, France
  • Unité de Recherche Clinique, Assistance Publique - Hôpitaux de Paris, Hôpital Fernand Widal, Université Paris 7, 75 010, Paris, France
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s13063-016-1350-0

    DOI

    http://dx.doi.org/10.1186/s13063-016-1350-0

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1029806629

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/27140403


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