Satisfaction Understanding of Patients and Relatives in Emergency Room (SUPER4)
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|ClinicalTrials.gov Identifier: NCT01848574|
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : September 28, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|All Inpatient in Short Stays Emergencies||Other: standardized multifaceted information procedure to improve patients' comprehension||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1816 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Satisfaction Understanding of Patients and Relatives in Emergency Room|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
No Intervention: Usual procedure
Investigators will give medical information to their patients as usual.
Experimental: Experimental procedure
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:
Other: standardized multifaceted information procedure to improve patients' comprehension
- Global Comprehension [ Time Frame: Day 0 ]Completing the questionnaire independently by the doctor and the patient after patient and physician interview final and comparison of responses
- Comprehension of each items [ Time Frame: Day 0 ]Completing the questionnaire independently by the doctor and the patient after patient and physician interview final and comparison of responses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848574
|Paris, France, 75014|
|Principal Investigator:||Yann-Erick Claessens, MD, PhD||Cochin Hospital|