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临床试验/NCT03840564
NCT03840564已完成不适用

Impact of Biological Point of Care Devices Implementation on the Length of Stay of Patients in Emergency Room

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2018年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20,000
试验地点
1
主要终点
length of stay (LOS) of patients consulting the ED

研究概览

简要总结

"Main objective: to demonstrate that the implementation of an extended panel solution for the point of care analysis of biological parameters (point of care : POC) in an emergency department (ED) reduces the length of stay (LOS) of patients Secondary objectives: to demonstrate the feasibility of implementing an expanded panel of POC solutions in an ED and the reduction of emergency overcrowding in the POC group.

To determine the medico-economic impact of the extended implementation of POC solutions (cost-efficiency and health-economic study), to collect the satisfaction of medical (emergency physicians, medical biologists) and paramedical personnel as well as the satisfaction of patients.

Inclusion criteria: Any patient consulting in the emergency department during the study period Non-inclusion criteria: Patients attending the emergency departments as part of dressing or trauma follow-up consultations Main criteria of judgment: Time between administrative registration and the patient's discharge or hospitalization decision, compared between the control period and the intervention period (POC).

Design: Prospective, monocentric, controlled, cluster- randomized per week. Duration of center preparation (technical preparation and training of laboratory staff): 4 weeks Duration of inclusion period: 18 weeks Duration of patient participation: 1 day Total trial duration time: 22 weeks"

详细描述

"SUPOC is a monocentric, prospective, open-label, controlled study, randomized into one-week inclusion periods, with 2 types of period: period POC (biological analysis performed as POC in a dedicated emergency room implemented with POC devices) and period control (analysis performed sent and processed in the central laboratory). Randomisation will be carried out by periods of one week (periods of a whole week 24h/24 from Monday 8am to Sunday 8 pm: control period or POC period, with a wash-out period between Sunday 08 pm and Monday 8am before each change of period (in order to limit the patients overlap on 2 periods). The entire medical care including the clinical examination, the prescriptions for additional radiological or biological examinations, requests for specialist advice, as well as the conclusion of the medical file will be left to the sole discretion of the emergency physician in charge of the patient and dictated solely by the reason for consultation and the patient evolution. The comparability of the POC and control periods will be verified, quantitatively (number of patients, average number of paramedical personnel present, the number of medical personnel being fixed) and qualitatively (triage scale applied by the triage nurses into 5 classes).

Despite the randomization of the two periods, the study type is best described as "Observational" because there is no specific intervention or health outcome at the subject level at all. The fact that blood samples are sent in the central laboratory or in the POC platform are both considered as routine medical care. No investigator assigns a specific intervention to the study participants; it is the emergency department itself which changes its internal organization (the destination of the biologic samples) every week. In conclusion, the purpose of the study is to examine the effect of a health provider intervention (POC vs central laboratory use) on a health provider outcome (mean length of stay according to the study period), and there is no health outcomes at the patient level. According to the ICMJE guidelines, this type of study should not be considered as an interventional clinical trial (http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/).

For organizational reasons, 3 laboratory technicians will be recruited and trained specifically for the study. They will be in charge of biological testing during POC periods.

Primary evaluation criteria: length of stay (LOS) of patients consulting the ED, defined by the time between the administrative registration and the medical decision of discharge or hospitalization of the patient. This LOS for each patient meeting the eligibility criteria will be extracted by the hospital's informatic department from the emergency file database. Secondary endpoints: - -the feasibility of an expanded POC menu in the ED will be assessed by the ""converted"" analysis rate, i.e. the number of analyses sent to the central laboratory in the POC period divided by the total number of analyses performed as POC during the period, the rate of unavailability of each POC device for maintenance or breakdown, i.e. the cumulative number of minutes of unavailability for all the POC equipment compared to the total duration of the POC group's periods.

ED's crowding will be evaluated by: the waiting time in each period (time in minutes between emergency registration and first medical contact), the occupancy rate defined by - at time t- the number of patients present / ED's capacity. The capacity of the service is estimated on the basis of the total number of boxes and beds, including short-term hospitalisation units. An overcrowding is set to an occupancy rate> 150%. In practice,it will be extracted by the informatic department from emergency database every day of the study at 12pm, 6pm, 12am and 8am.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient consulting in the emergency department during the study period

排除标准

  • Patients attending the emergency departments as part of dressing or trauma follow-up consultations

结局指标

主要结局

length of stay (LOS) of patients consulting the ED

时间窗: 1 Week

length of stay (LOS) of patients consulting the ED For each patient the time frame of LOS is comprised between the admission schedule in the ED and the schedule of medical conclusion on the medical file of each patient consulting the emergency department

次要结局

  • satisfaction of patients(the last two weeks of the study: one week in the intervention period (POC) and one week in the control period (usual care))
  • Incidence and duration of technical adverse events encountered with the POC platform(through study completion (18 weeks))
  • ED's crowding(1 Week, i.e. the size of one cluster period of observation)
  • The time to results in each period and by biological parameter(1 Week, i.e. the size of one cluster period of observation)
  • health-economic impact(through study completion (18 Weeks))
  • satisfaction of all staff(the last two weeks of the study: one week in the intervention period (POC) and one week in the control period (usual care))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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