Specialist Advice Support for Management of Severe Hereditary Angioedema Attacks: A Multicenter Cluster-Randomized Controlled Trial.

STUDY OBJECTIVE: Hereditary angioedema is a rare disease associated with unpredictable, recurrent attacks of potentially life-threatening edema. Management of severe attacks is currently suboptimal because emergency medical teams are often unaware of new specific treatments. The objective of this trial is to test whether a dedicated national telephone care-management strategy would reduce resource use during severe hereditary angioedema attacks. METHODS: We conducted a cluster-randomized multicenter prospective trial of patients with a documented diagnosis of hereditary angioedema (type I, II or FXII hereditary angioedema). Participants were enrolled between March 2013 and June 2014 at 8 participating reference centers. The randomized units were the reference centers (clusters). Patients in the intervention arm were given a national free telephone number to call in the event of a severe attack. Emergency physicians in the SOS-hereditary angiœdema (SOS-HAE) call center were trained to advise or prescribe specific treatments. The primary outcome was number of admissions for angioedema attacks. Economic evaluation was also performed. RESULTS: We included 100 patients in the SOS-HAE group and 100 in the control group. During the 2 years, there were 2,368 hereditary angioedema attacks among 169 patients (85%). Mean number of hospital admissions per patient in the 2-year period was significantly greater in the usual-practice group (mean 0.16 [range 0 to 2] versus 0.03 [range 0 to 1]); patient risk difference was significant: -0.13 (95% confidence interval -0.22 to -0.04; P=.02). Probabilistic sensitivity graphic analysis indicated a trend toward increased quality-adjusted life-years in the SOS-HAE group. CONCLUSION: A national dedicated call center for management of severe hereditary angioedema attacks is associated with a decrease in hospital admissions and may be cost-effective if facilities and staff are available to deliver the intervention alongside existing services.

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.

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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02286245 , registered on 9 September 2014.

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

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 .