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

Primary Purpose

All Inpatient in Short Stays Emergencies

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standardized multifaceted information procedure to improve patients' comprehension
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for All Inpatient in Short Stays Emergencies focused on measuring Understanding, Patients, Emergency, Information

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual procedure

Experimental procedure

Arm Description

Investigators will give medical information to their patients as usual.

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.

Outcomes

Primary Outcome Measures

Global Comprehension
Completing the questionnaire independently by the doctor and the patient after patient and physician interview final and comparison of responses

Secondary Outcome Measures

Comprehension of each items
Completing the questionnaire independently by the doctor and the patient after patient and physician interview final and comparison of responses

Full Information

First Posted
February 19, 2013
Last Updated
September 24, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01848574
Brief Title
Satisfaction Understanding of Patients and Relatives in Emergency Room
Acronym
SUPER4
Official Title
Satisfaction Understanding of Patients and Relatives in Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
All Inpatient in Short Stays Emergencies
Keywords
Understanding, Patients, Emergency, Information

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1816 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual procedure
Arm Type
No Intervention
Arm Description
Investigators will give medical information to their patients as usual.
Arm Title
Experimental procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
standardized multifaceted information procedure to improve patients' comprehension
Primary Outcome Measure Information:
Title
Global Comprehension
Description
Completing the questionnaire independently by the doctor and the patient after patient and physician interview final and comparison of responses
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Comprehension of each items
Description
Completing the questionnaire independently by the doctor and the patient after patient and physician interview final and comparison of responses
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yann-Erick Claessens, MD, PhD
Organizational Affiliation
Cochin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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Satisfaction Understanding of Patients and Relatives in Emergency Room

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