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临床试验/NCT01848574
NCT01848574已完成不适用

Satisfaction Understanding of Patients and Relatives in Emergency Room

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 1,816 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,816
试验地点
1
主要终点
Global Comprehension

研究概览

简要总结

Evaluation of global understanding and with items of patients admitted to the emergency.

Prospective observational study randomized in cluster during 6 weeks in 14 centers

详细描述

Patients' comprehension in the emergency department (ED) is relatively low. This is more evident for in-patients with more complex diseases. The preliminary study conducted suggests that patients' comprehension was improved by the use of standardized information and by opening a dialogue. This study however had its limits. It does not deliver proper information guideline to physicians working in the ED.

This study is reproduced on a larger scale for in-patients in the ED concerning their comprehension about the medical information given and thus improving the scientific evidence. This study has been conducted on a national level in 2 phases with 14 investigating centers spread in Paris and other provinces:

First, an observational period was conducted during 2 weeks in each center in order to document their homogeneity. At the same time, this period permitted to have a reference level of comprehension. During this period, investigators continued to give medical information to their patients as usual. The aim is to adjust the results of the comprehensions levels in 2 groups after the experimental study on the "baseline" data.

Second, an experimental period of 4 weeks: 7 centers are identified as "formal procedure group" and their investigators are provided with formal procedures on the patient's comprehension in the ED based on updated literature data. At the same time, recommendations are given on the information given to patients. 7 other centers "control group" only formal presentation on the patient's comprehension in the ED on updated literature data.

According to the center where the patient is included, he will be either in the "formal procedure group" or the "control group".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • •Patient aged 18 years and over
  • •Inpatient Unit in Short Term Hospitalization (UHCD)
  • •Patient who agreed to participate in the study
  • •Patient affiliated to a social security scheme (beneficiary or righ)

排除标准

  • •Patient has already been included in the study, which was re-hospitalized for the same reason UHCD
  • •Patient in judicial restraint (certificate of non-admission in custody, incarcerated)
  • •Patient for which a decision forced hospitalization was taken
  • •Patient non-Francophone
  • •Patients with underlying cognitive and unable to give their consent
  • •Patient opposed to participate in the study

研究组 & 干预措施

Usual procedure

No Intervention

Investigators will give medical information to their patients as usual.

Experimental procedure

Experimental

You must use the standardized patient information. The final Information of the patient before the final output should be clear and concise in the presence of trustworthy people if the patient wishes.

Deliver the following information in the orde of the items below:

Decline your identity and function Provide a final diagnosis, indicating the affected organ and Inform prognosis (any severity), and the potential duration of affection

Briefly additional tests:

  • Radio show
  • Explain the main abnormalities Explain treatment modalities and setpoint monitoring Finish with an open question: "Do you have questions? "If you think the state anxiety or depression alters the patient's understanding, still deliver all the information listed above.

干预措施: standardized multifaceted information procedure to improve patients' comprehension (Other)

结局指标

主要结局

Global Comprehension

时间窗: Day 0

Completing the questionnaire independently by the doctor and the patient after patient and physician interview final and comparison of responses

次要结局

  • Comprehension of each items(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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