Satisfaction Understanding of Patients and Relatives in Emergency Room

All Inpatient in Short Stays Emergencies Clinical Trial

— SUPER4  

Official title:

Satisfaction Understanding of Patients and Relatives in Emergency Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848574
• Other study ID #: NI10067
• Status: Completed
• Phase: N/A
• First received: February 19, 2013
• Last updated: September 24, 2015
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1816
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• All Inpatient in Short Stays Emergencies
• Emergencies

Intervention

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

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Comprehension	Completing the questionnaire independently by the doctor and the patient after patient and physician interview final and comparison of responses	Day 0	No
Secondary	Comprehension of each items	Completing the questionnaire independently by the doctor and the patient after patient and physician interview final and comparison of responses	Day 0	No