The Use of a Monitoring Device by General Practitioners During Out-of-hours Care: Protocol of a Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 866
- 试验地点
- 2
- 主要终点
- The number of correct referred participants in the intervention arm is a minimum of 11% higher than the correct referred participants in the usual care arm.
研究概览
简要总结
All calls that end up on the out-of-hours general practitioners' service (OHGPS), which contain a demand for an urgent home visit, are passed on to the on-call general practitioner (GP). These calls are randomized into two arms: after the patient's informed consent, they are assigned either to one arm where the monitoring device, PICO, is applied together with the GP's general care or to the other arm where only the usual care is provided. All data such as suspected diagnosis, treatment or referral, influence of the parameters, ECG and/or alarms on the management and the user-friendliness are recorded. After 30 days, the diagnosis and evolution is requested from the patient's own GP or, if referred to a hospital, in the hospital in order to be able to compare the effect of the approach by the GP between both arms. The aim is to investigate if 1/ the use of the PICO monitoring device could improve GPs' decisions to refer to hospital or not in urgent cases; 2/ there is a difference between the diagnosis with and without the use of the monitoring device using the final diagnosis by the electronic health record of the own GP of the patient; 3/ the call to send a GP for an emergency contained sufficient information for the OHGPS phone operator to take an appropriate decision; 4/ the build-in alarms help the GP during his intervention; 5/ the PICO is easy to use during an emergency; 6/ the use of the device makes them feel more confident in transmitting the information to the Medical Emergency Team.
详细描述
INTRODUCTION Calls to an out-of-hours general practitioner's service (OHGPS) for an emergency could originate from different types of callers. Based on the information provided over the phone, it is sometimes difficult to figure out to what extent the call can actually be considered urgent.
The development of the out-of-hours services by GPs in Belgium recently led to the introduction of a uniform urgent phone number 1733 for out-of-hours calls. The phone operator can send a GP for an urgent home-visit, ask the patient to go to the OHGPS, to wait until the next available appointment with his/her regular GP or go to the emergency department (ED) immediately. The OHGPS phone operator must be able to differentiate an urgent situation from the vast majority of semi-urgent calls.
The assessment of an acutely ill patient relies on the clinical data observed and measured by GPs. During an urgent home visit, a GP is typically multitasking: taking clinical history, performing clinical examination, formulating a diagnostic hypothesis, administering medication and also checking as many vital parameters as possible. There is hardly any time left to make notes. They could also miss some changes in the patient's status and they do not have a monitoring device similar to the one EPs carry.
The possibility of checking the monitored records retrospectively, is not only useful to review data during the period between the GP's and the emergency physician's (EP) arrival. Data can also be reproduced at a later stage, e.g. during transport of the patient or during stay at the ED. All information, recorded by a GP before the arrival of the EP, is crucial to support diagnosis, treatment and prognosis.
After an extensive literature review, the investigators did not find a single paper on the use of portable monitoring devices by GPs in out-of-hospital emergencies. There are many devices on the market capable of measuring more than one parameter. Unfortunately, most of them are too large and heavy, and do not record all parameters, are unable to transmit results to another device, or do not contain a reproducible memory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From the calls at the 112-1733 dispatch sent to the OHGPS dispatch centre, those for whom the decision by the OHGPS dispatcher is to send a GP for an urgent home visit.
- •All GPs on duty and chauffeurs of the OHGPS in Belgium, present during the study period are recruited after signing an ICF. GPs' age, gender and years of practice will be recorded.
- •All patients 18 years and older, for whom a home visit is requested, seen by a participating GP and if the informed consent form is signed either by the patient or by the legal representative, either onsite or at a later time.
排除标准
- •Patients younger than 18 years
- •Patients not seen during home visits,
- •Patients failed to provide informed consent
- •Patients with an acute trauma but not in a possible life-threatening situation (e.g. a broken bone)
- •Victims found lying on the street
- •Patients seen after the intervention of an ambulance, a Primary Intervention Team (PIT) or a Medical Emergency Team (MET)
- •Patients not meeting inclusion criteria
- •Patients refusing to participate
结局指标
主要结局
The number of correct referred participants in the intervention arm is a minimum of 11% higher than the correct referred participants in the usual care arm.
时间窗: 30 days after intervention
A correct referral is defined as follows: a patient referred to hospital staying more than 12 hours in the hospital; a patient referred only for a diagnostic test, e.g. an X-Ray, an ECG, a blood test, advice of a consultant, and no hospitalisation followed; a patient referred to his own GP was not hospitalised within 72 hours for the same reason. The aim of the study is to investigate the percentage of correct referrals in both arms and to determine if the percentage in the intervention arm is 11% or more higher than in the usual care arm.
次要结局
- The rate of correct diagnosis in the intervention arm is a minimum of 11% higher than the rate of correct diagnosis in the usual care arm.(30 days after intervention)