Satisfaction Understanding of Patients and Relatives in Emergency Room

NCT ID: NCT01848574

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1816 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-03-31

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

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.

Conditions

All Inpatient in Short Stays Emergencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual procedure

Investigators will give medical information to their patients as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

standardized multifaceted information procedure to improve patients' comprehension

Intervention Type: OTHER

Interventions

standardized multifaceted information procedure to improve patients' comprehension

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yann-Erick Claessens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cochin Hospital

Locations

Cochin Hospital

Paris, , France

Countries

France

Other Identifiers

NI10067

Identifier Type: -

Identifier Source: org_study_id