- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01848574
Satisfaction Understanding of Patients and Relatives in Emergency Room (SUPER4)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Paris, France, 75014
- Cochin Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual procedure
Investigators will give medical information to their patients as usual.
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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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Day 0
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yann-Erick Claessens, MD, PhD, Cochin Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI10067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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