遗传性血管性水肿发作专用呼叫中心（SOS-HAE）：一项随机对照试验的研究方案
Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial.
作者信息
Javaud Nicolas, Fain Olivier, Durand-Zaleski Isabelle, Launay David, Bouillet Laurence, Gompel Anne, Sobel Alain, Woimant Maguy, Rabetrano Hasina, Petrovic Tomislav, Lapostolle Frédéric, Boccon-Gibod Isabelle, Reuter Paul-Georges, Bertrand Philippe, Coppere Brigitte, Floccard Bernard, Kanny Gisele, Martin Ludovic, Vicaut Eric, Adnet Frédéric
机构信息
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.
出版信息
Trials. 2016 Apr 30;17(1):225. doi: 10.1186/s13063-016-1350-0.
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/DESIGN: 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).
DISCUSSION
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.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01679912 .
背景
尽管有针对遗传性血管性水肿（HAE）发作的特定治疗指南，但HAE的发病率和死亡率仍然很高。HAE发作是一个需要特定治疗的重大医学问题，也是一个相当大的社会经济负担。我们报告了一项方案，旨在测试一个专门的呼叫中心在管理HAE发作患者方面是否比常规做法更有效。
方法/设计：这项前瞻性、整群随机、单盲、平行组、多中心试验评估了与常规做法相比，由专门的呼叫中心管理HAE发作患者的发病率及由此产生的社会经济成本。该试验旨在招募200名患者。干预组的患者会收到一张带有呼叫中心免费电话号码的SOS-HAE卡，在发作时可以拨打。该中心的任务是提供关于早期家庭治疗的专家建议。该中心可以将呼叫转接至具备HAE管理能力的当地紧急医疗服务机构，甚至安排将HAE发作特定治疗所需的药物送到当地医院的急诊科。主要结局指标是因HAE发作而住院的次数。每位患者将在2年内每2个月接受一次随访。该研究已获得伦理委员会批准（法兰西岛大区保护人类委员会10；注册号：2012-A00044-39；批准日期：2012年1月19日）。
讨论
SOS-HAE方案旨在解决HAE患者在家中发作的处理问题。拟进行的试验将确定建立一个专门的呼叫中心在降低住院次数所反映的发病率方面是否比常规做法更有效。预计结果在医疗服务和患者的社会经济成本方面也将具有重要意义。
试验注册
ClinicalTrials.gov NCT01679912
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