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临床试验/NCT04312321
NCT04312321已完成不适用

Audiovisual Consultations by Paramedics With an Emergency Medical Service Physician in Low Urgency Events: Randomised Controlled Trial

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
Non-transport of low urgency EMS case to hospital

研究概览

简要总结

This study investigates safety and efficacy of the use of audiovisual consultations of emergency medical service (EMS) doctor by paramedics for low urgency events in areas covered with paramedic crews only from emergency medical service stations with distant access to hospital.

详细描述

The study will be realized on Karlovy Vary EMS areas covered with paramedic crews only from emergency medical service stations with distant access to hospital. Each call on emergency line during 6 weeks study period will be assessed for eligibility. If deemed as low urgency, the event will be randomised into 3 groups. CONTROL group: routine operation of paramedic crew with optional consultation with a doctor over the phone. In the PHONE group and in the VIDEO group, there will be a mandatory consultation of a doctor over the phone or by audiovisual constultation, respectively. The primary outcome of the study is the percent of patients treated on site without the need of hospital transfer. The secondary safety outcome is to evaluate repeated ambulance trips within 48 hours after the patient had been treated at home. Moreover, a qualitative analysis of subjective perception of the event by the patients, paramedic and consulting doctor using the Likert scales will be performed by survey at the end or immediately after the event.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Each call on emergency line (in action radius of actual position of 11 of 19 Karlovy Vary EMS paramedic crews) will be assessed for eligibility by EMS call-taker in Karlovy Vary region.
  • Inclusion criteria are:
  • the call is evaluated as low urgency event (by criteria of Karlovy Vary EMS call-taker manual; the event is dedicated for paramedic crew only, without dispatchig doctor on site),
  • the case is determined for and will be served by one of 11 for study dedicated of total 19 paramedic crews in Karlovy Vary EMS,
  • dedicated doctor of Karlovy Vary EMS will be available for consultation during his shift.

排除标准

  • need for escalation of the care: paramedics' requirement for the doctor to arrive at the scene of intervention,
  • consulting doctor is not available for the study at the moment of randomisation,
  • consultation with other than trained and for study dedicated doctors,
  • patient - crew language barrier,
  • study refusal by the patient or legal representative, or refusal of audiovisual consultation,
  • technical, logistic or other (agressive patient, patient detained by police) problems evaluated by paramedic crew (not to conduct a study in PHONE and especially VIDEO group)

结局指标

主要结局

Non-transport of low urgency EMS case to hospital

时间窗: until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study

Based on Karlovy Vary EMS audit data, there is 10% of low urgency cases treated and left on site by paramedics so far. So the primary outcome is to evaluate the rate of non-transports in common daily routine, when the doctor provides phone call consultation on request of paramedics (based on Karlovy Vary EMS protocol) to mandatory phone call consultation and audiovisual consultation with a EMS doctor. Therefore, the primary objective is to evaluate potential benefit audiovisual consultation with EMS doctor on the rate of patients left at home after treatment on site by paramedics.

次要结局

  • The rate of repeated trips within 48 hours after the patient had been treated at home.(until 200 cases per group are collected, estimated time 6-8 weeks from the beginning of the study)

研究者

发起方
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roman Sýkora, MD, Ph.D.

Principal Investigator

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

研究点 (1)

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