Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Primary Care: the Formalised Telephone Medical Advice Study, a Cluster Randomised Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,498
- 试验地点
- 1
- 主要终点
- Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods
研究概览
简要总结
Telephone medical advice in general practice is expanding. The Cochrane Database concludes in 2008 that there is not enough data about its use regarding out-of-hours general practitioners workload, emergency department visits, cost, safety and patient satisfaction. The aim of this study is to assess the effectiveness of telephone medical advice given by a general practitioner in a call centre for patient presenting isolated fever or gastroenteritis symptoms.
详细描述
This is a prospective, open label, cluster randomized trial of 2 880 expected patients who calling a French emergency medical service Dial 15 for fever or gastroenteritis symptoms during out-of-hours periods. All calls will be taken by a general practitioner (GP). Out-of-hours period is defined as 8 PM to 8 AM on weekdays, 1 PM to 8PM on Saturdays in addition to Sundays and holidays.To be exhaustive, we will enrol patients during one year.
In the experimental arm, the GP will implement a protocol of care to each patient call. The protocol includes medical advice, drug prescription by phone and supervisory board. Patients are invited to recall in case of worsening or onset of new symptoms and to get an appointment with their GP during working hours.
In the non-interventional arm, the GP will decide the need of telephone advice with or without drug prescription, home visit by a doctor, emergency department services with or without EMS system.
We will recall every patient at 15+/-4 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fever: temperature ≥ 38 ° C
- •Symptoms of gastroenteritis include nausea and / or vomiting and / or diarrhea
- •Onset of symptoms for less than 72 hours
- •Age ≥ 18 years caller
- •Patient age ≥ 1 year
- •Affiliation to the French National Health Service
排除标准
- •Pregnancy
- •Severity criteria (fever> 41 ° C, disturbance of consciousness, rash, dyspnea, signs of dehydration, chest pain, neurological signs, gastrointestinal bleeding)
- •Seeking advice from institutional correspondents (fire brigade, police, airport...)
- •Communication difficulties (non-communicating patient, language barrier...)
研究组 & 干预措施
1: focused Telephonic Medical Advice
The physician will implement a protocol of care to each patient call for an isolated fever and/or symptoms of gastroenteritis: medical advice, drug prescription by phone and supervisory board. Patients are invited to recall in case of worsening or onset of new symptoms and to get an appointment with their general practitioner during working hours.
干预措施: focused Telephonic Medical Advice (Other)
2: Usual practice
The physician will decide for the same disease (isolated fever and/or symptoms of gastroenteritis) the need of telephone advice with or without drug prescription, home visit by a doctor, emergency department services with or without EMS system.
干预措施: Usual practice (Other)
结局指标
主要结局
Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods
时间窗: at 15 days
Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods
次要结局
- Care Mobile Units use(at 15 days)
- Number of patients seen repeatedly(at 15 days)
- Patient satisfaction(at 15 days)
- Patient adhesion(at 15 days)
- Clinical outcome(at 15 days)
- Cost effectiveness(at 15 days)
- Emergency Medical Service use(at 15 days)
- Firemen use(at 15 days)
- Recall at dispatching centre(at 15 days)
- Number and length of sick leave(at 15 days)
- All causes mortality(at 15 days)
- Morbidity(at 15 days)
- Number of stay in intensive care unit(at 15 days)
- Number of hospitalisation(at 15 days)