Clinical trial NCT01848574: Satisfaction Understanding of Patients and Relatives in Emergency Room
Official title: Satisfaction Understanding of Patients and Relatives in Emergency Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: All Inpatient in Short Stays Emergencies
Keywords: Understanding
Patients
Emergency
Information
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 1816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Global Comprehension
timeFrame: Day 0
Secondary outcomes:
measure: Comprehension of each items
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Cochin Hospital
name: Yann-Erick Claessens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: