Contribution of a Video Support to Inform the Patient Before a Complementary Examination in Infectious Diseases

Infectious Disease Clinical Trial

— AVIEMI  

Official title:

Non Interventional Study Evaluating the Contribution of a Video to Patient Information Before a Complementary Examination in Infectious Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06168448
• Other study ID #: APHP 230351
• Secondary ID: 2023-A00266-39
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Elisabete GOMES PIRES, Nurse
• Phone: +33 1 42 19 27 19
• Email: elisabete.gomes-pires[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is that a video tool coupled with standardized information can increase the patient's understanding of the information and thus optimize their medical care

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 97
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease

Intervention

Other:
• Oral and written information
Legal oral and written information given by physicians concerning additional examinations
• Video information
Explanatory video applied after physician's formal information

Locations

Country	Name	City	State
France	Hôpital Necker Enfants malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of perceived understanding of information before additional examination	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	Score of perceived understanding of information after additional examination	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
Secondary	Failure rate of examinations	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
Secondary	Missing elements	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
Secondary	Impact on caregivers' knowledge	using a self-questionnaire	1 day