- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03117179
Patient Follow-up After Consultation in Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Each year more than 15 million French people visit the emergency services and almost 80% of them come out without hospitalization after having undergone a clinical examination and possibly additional examinations.
Following their discharge, compliance with discharge requirements and recommendations (treatment, monitoring, follow-up, etc.) is a determining factor in improving their health. Non-membership is linked to an increase in morbidity, mortality and use of the health system. Patient adherence to discharge instructions is conditional on patient understanding. Unfortunately, the environment of an emergency service often creates conditions for information and education of the patient that are often far from optimal or at least that are specific to a typical consultation.
Data from the international literature showed that 78% of people who come out of emergency after consultation do not clearly understand the instructions and only 20% are aware of their lack of understanding. Waisman et al. Documented that 25% of patients did not understand their diagnosis and that 13% to 18% did not understand treatment instructions. Heng et al. Have shown that patients leaving after head trauma are unable to cite the symptoms that should prompt them to consult quickly.
The involvement of healthcare teams to inform patients with the help of different communication media is therefore particularly important in trying to improve understanding and adherence to exit instructions. However, Zavala et al. Point to the fact that this is not necessarily sufficient.
Some authors have identified factors of poor adherence: multiple chronic diseases, multiple drug treatments, psychiatric disorders, but also age, social isolation, depression, quality of life and socio-economic and cultural level , A low level of health literacy, or planned medical follow-up, the severity of the pathology and the perception of that severity by the patient, or the patient's dissatisfaction with medical instructions.
The patients' adherence to the literature is evaluated in a varied manner according to the pathologies concerned: counting the number of tablets; Patient self-tracking log; Reports from physicians, reports by third parties (such as the patient's spouse); Electronic measurements (for example, metered-dose inhalers or electronic drop dispensers); Blood or urine dosage. The different methods used have advantages and disadvantages that need to be assessed according to the needs of the study we wish to implement. While declarative investigations in the assessment of patient adherence are criticized, no method has unfortunately been used as a benchmark for assessing adherence. The bibliographic search did not find any questionnaires that had been validated in this context. In order to evaluate the adhesion, the investigator will therefore opt for a semi-directed interview at D7 in order to better control a possible bias of memorization. This tool has known limitations including a tendency to overestimate adhesion, because patients tend to respond to what doctors want to hear. This will be taken into account in the interpretation of the results.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maxime GIGNON, Dr
- Phone Number: +33322667606
- Email: gignon.maxime@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80054
- CHU Amiens Picardie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Major patient not benefiting from any legal protection measures.
- Speaking French.
- Outgoing after having received a consultation in a hospital emergency department.
- Accepting to participate in the study after being informed of the protocol.
- Having the possibility to be reached by telephone on J7.
Exclusion Criteria:
- Patient with a pathology that does not allow him or her to understand instructions or express themselves.
- Patient under tutelage or curatorship or deprived of all freedom.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patient with an interview
|
Discharge from patient after consultation in emergency department
|
Other: Patient without an interview
|
Discharge from patient after consultation in emergency department
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of patient compliance with discharge
Time Frame: 7 days
|
Analysis of patient compliance with discharge orders issued after consultation in emergencies determined by telephone interview
|
7 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2013_843_0012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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