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

Nicolas Javaud,Laurence Bouillet,Ludovic Martin,Hasina Rabetrano,David Launay,Frédéric Lapostolle,Anne Gompel,Olivier Fain,Maguy Woimant,Bernard Floccard,Frédéric Adnet,Éric Vicaut ,Isabelle Boccon‐Gibod ,Alain Sobel ,Philìppe Bertrand ,Tomislav Pétrovic ,Isabelle Durand‐Zaleski ,B Coppéré ,G Kanny ,Paul‐Georges Reuter

doi:10.1186/s13063-016-1350-0

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.

Highlights

Despite the availability of guidelines for the specific treatment of hereditary angioedema (HAE) attacks, HAE morbidity and mortality rates remain substantial
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
A prospective study on the impact of measures, in particular specific home treatments, that might shorten the time from attack onset to first contact with a healthcare professional is required [12]

Summary

Introduction

Despite the availability of guidelines for the specific treatment of hereditary angioedema (HAE) attacks, HAE morbidity and mortality rates remain substantial. Patients with C1-INH deficiency may have type I or type II HAE [2, 3]. Patients with a family history of angioedema but with normal C1-INH levels may have a mutation of the gene encoding human coagulation factor XII (FXII-HAE) [2]. More than half of all HAE patients experience at least one laryngeal attack during their lifetime with the associated risk of asphyxiation [7]. Despite the availability of guidelines on specific treatments for HAE attacks, morbidity and mortality rates remain substantial [2, 3, 8]

Objectives

Methods

Findings

Conclusion