- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06168448
Contribution of a Video Support to Inform the Patient Before a Complementary Examination in Infectious Diseases (AVIEMI)
Non Interventional Study Evaluating the Contribution of a Video to Patient Information Before a Complementary Examination in Infectious Diseases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients admitted to the Infectious and Tropical Diseases Department (MIT) undergo a large number of complementary examinations. In view of their specificity, justified by the often lengthy diagnostic process, as well as by the complexity and diversity of the pathologies, the site of infection and the patient's background (adolescents and adults, migrant patients, immunocompromised patients, Human Immunodeficiency Virus, primary immunodeficiencies, organ transplants, patients with haemopathies, marrow transplants, among others). As a matter of practice, the doctor informs the patient of the prescribed examinations, explaining their purpose and procedure, and outlining any benefits and risks.
The intention is to introduce a tool that complements the information usually provided, and that can be of high quality to improve the patient's perception of understanding. To this end, investigators hypothesize that a tool in video format, built in collaboration with the experience of various technical platforms, could make the experience of understanding information more complete and more accessible to all patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75015
- Hôpital Necker Enfants Malades
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Hospitalized patients in the Department of Infectious and Tropical Diseases at Hôpital Necker- Enfants maladies.
Caregivers working in the Infectious and Tropical Diseases Department at Necker Hospital
Description
Inclusion Criteria:
- Patient aged ≥ 18 years
- French speaking language
- Hospitalized in the Department of Infectious and Tropical Diseases at Hôpital Necker- Enfants malades
Prescription, for the first time in its medical history, of one of the following complementary examinations:
- Bronchial FibroscopyIRM
- PICC line insertion
- PET Scanner
- No expressed oral opposition
Exclusion Criteria:
- Patients with dementia or cognitive impairment
- Non-French-speaking patient
Caregivers' inclusion Criteria:
- Caregiver belonging at nurse or doctor's category
- Caregiver working in the Infectious and Tropical Diseases Department at Necker Hospital
- No expressed oral opposition
- Caregivers who are not in contact with patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1 : Patients with oral and written information
Group made up of patients hospitalized at that time in the infectious diseases department who met the eligibility criteria set out in the protocol. This group of patients will receive the legal oral and written information concerning the additional examination prescribed, as usually delivered by their doctor. |
Legal oral and written information given by physicians concerning additional examinations
|
|
Group 2 : Patients with oral and written information + video information
Group made up of patients hospitalized at that time in the infectious diseases department who met the eligibility criteria set out in the protocol. This group of patients will receive the legal oral and written information concerning the additional examination prescribed, as usually delivered by their physician, and in addition the video tool will be applied to them. |
Legal oral and written information given by physicians concerning additional examinations
Explanatory video applied after physician's formal information
|
|
Group 3 : Caregivers
Nurses and physicians working in the infectious and tropical diseases department. This group of caregivers will assess the impact of the intervention on their practice. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score of perceived understanding of information before additional examination
Time Frame: up to 7 days
|
Measure the patient's perception of comprehension prior to the examination, using a self-assessment Numerical Scale (NRS) defined from zero (no comprehension) to ten (perfect comprehension).
The assessment will be collected by a caregiver who is not in charge of the patient, within a maximum of 24 hours after the carried out examination.
|
up to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score of perceived understanding of information after additional examination
Time Frame: up to 7 days
|
Measure the patient's perception of comprehension after the examination, using a self-assessment Numerical Scale (NRS) defined from zero (no comprehension) to ten (perfect comprehension).
|
up to 7 days
|
|
Failure rate of examinations
Time Frame: up to 7 days
|
A failure is defined as an examination not performed and/or an examination that cannot be interpreted.
The failure is recorded upon return from the examination via the report provided by the technical platform and certified by the physician
|
up to 7 days
|
|
Missing elements
Time Frame: up to 7 days
|
Collection of elements identified as missing by the patient during the examination.
A questionnaire will completed by the patient at his return, in a maximum of 24 hours
|
up to 7 days
|
|
Impact on caregivers' knowledge
Time Frame: 1 day
|
using a self-questionnaire
|
1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Fanny LANTERNIER, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Principal Investigator: Elisabete GOMES-PIRES, Nurse, Assistance Publique - Hôpitaux de Paris
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP 230351
- 2023-A00266-39 (Other Identifier: ID-RCB)
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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