Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Satisfaction Understanding of Patients and Relatives in Emergency Room (SUPER4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01848574
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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


Condition or disease Intervention/treatment Phase
All Inpatient in Short Stays Emergencies Other: standardized multifaceted information procedure to improve patients' comprehension Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1816 participants
Allocation: Randomized
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

Arm Intervention/treatment
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:

  • 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.
Other: standardized multifaceted information procedure to improve patients' comprehension



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
France
Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Yann-Erick Claessens, MD, PhD Cochin Hospital

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01848574     History of Changes
Other Study ID Numbers: NI10067
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: August 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Understanding
Patients
Emergency
Information

Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes