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Clinical Trial Summary

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


Clinical Trial Description

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".

Among all in-patients in the ED, it is planned to include:

- 700 patients in the observational period (50 in each center)

- 1400 patients in the experimental period (700 in the formal procedure group and 700 in the control group)

Improvement in the information given to patients is expected due to the participation of the centers in this study. This improvement is expected in both arms only due to the fact of their participation. Better information level is expected in the "formal procedure group".

If this study proves a better information in the procedure group, then our aim will be to propose recommendations to ED physicians to improve the information given to in-patients in the ED. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT01848574
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase N/A
Start date February 2012
Completion date March 2013