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| ID | Type | Description | Link |
|---|---|---|---|
| N° IDRCB: 2024-A | Other Identifier | ANSM |
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The ECHO93 study is a non-healthcare interventional study. Its aim is to evaluate the effect of introducing the echOpen probe into the management of patients referred to the Jean Verdier UDR, in terms of time to diagnosis.
The study is divided into 3 phases:
Phase 1: opening of the Rapid Diagnosis Unit (UDR) at Jean Verdier Hospital Phase 2: Opening of the Jean Verdier Hospital UDR, MSP Pantin, Dr TAYBALY's medical practice in Aulnay-sous-Bois, one month after the start of phase 1.
Phase 3: Opening of the Jean Verdier Hospital Health Bus, one month after the start of phase 2.
This research will be carried out in 3 phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| echoscopy examination using the echOpen probe | Other | In addition to standard care, each patient will have a systematic 4-point echoscopy examination using the echOpen probe: liver, spleen, lymph nodes, thyroid and, depending on symptoms, lung, kidney, bladder, abdomen. The echOpen probe is CE marked. It will be used for all indications except certain areas of the body (thyroid, lymph nodes, bladder, liver, spleen, kidney, bladder and lymph nodes). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echoscopy examination using the echOpen probe | Device | In addition to standard care, each patient will have a systematic 4-point echoscopy examination using the echOpen probe: liver, spleen, lymph nodes, thyroid and, depending on symptoms, lung, kidney, bladder, abdomen. The echOpen probe is CE marked. It will be used for all indications except certain areas of the body (thyroid, lymph nodes, bladder, liver, spleen, kidney, bladder and lymph nodes). In addition to echoscopy with the echOpen probe, patient and physician satisfaction questionnaires will be used as part of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of introducing the echOpen probe into the management of patients referred to the Jean Verdier Rapid Diagnostic Unit (UDR) on time to diagnosis. | The time between the first contact with the Rapid Diagnosis Unit (RDU) and the date of the diagnosis (date of discharge from the RDU) in patients who had an ultrasound scan with the echOpen probe in consultation at the RDU (phase 1) and in patients who had it in consultation with a general practitioner or in the emergency department (phase 2), compared with the time before the echOpen was introduced. | Visite discharge from the RDU ( Maximum 2 months after inclusion visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used. | - The number of complementary examinations prescribed/avoided, in comparison with the number of examinations prior to the introduction of the echOpen. | Visite discharge from the RDU ( Maximum 2 months after inclusion visit) |
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Inclusion Criteria:
Adult patient over 18 years of age
Patient with signed informed consent
Patient managed by:
Exclusion Criteria:
Patient on the UDR iron-deficiency anemia clinical pathway
Patient deprived of liberty by judicial or administrative decision
Patient who does not speak French and cannot benefit from the presence of a relative or translator (physical or online)
Patient with a contraindication to the use of EchOPen:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne BOURGARIT, PUPH | Contact | 00331 48 02 61 59 | anne.bourgarit@aphp.fr | |
| Fadhila MESSANI | Contact | 0033148957471 | fadhila.messani@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne BOURGARIT, PUPH | HUPSSD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unite de Diagnostic Rapide - Medecine Interne Hopital Jean Verdier | Recruiting | Bondy | France |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used. | - The time between the first consultation and the radioguided biopsy, if this is to be carried out | Visite discharge from the RDU ( Maximum 2 months after inclusion visit) |
| Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used. | - The number of patients accessing the UDR day hospital directly will be evaluated in patients having had an echoscopy with the echOpen probe in consultation at the UDR (phase 1) in comparison with the number of patients before the introduction of the echOpen. | Visite discharge from the RDU ( Maximum 2 months after inclusion visit) |
| Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used. | - The number of patients referred to the emergency department facilitated by the echOpen probe will be evaluated among patients who had an echOpen probe in the Health Bus (phase 3), compared with the number of patients before the echOpen was introduced. | Visite discharge from the RDU ( Maximum 2 months after inclusion visit) |
| Evaluate the satisfaction of physicians participating in the study with the introduction of the echOpen probe in the management of patients referred to the Jean Verdier UDR. | Physician satisfaction (phases 1 and 2) will be assessed by a questionnaire carried out at the end of the study. For Health Bus doctors (phase 3), the questionnaire will be completed after each patient consultation. A visual analog scale will be proposed in this questionnaire to assess doctors' overall satisfaction with the use of EchOpen. This scale ranges from 0 (very dissatisfied) to 10 (very satisfied). | Through study completion, an average of 2 years for phase 1 and 2, at each inclusion visit of patient (day 1) for phase 3 |
| Evaluate the satisfaction of physicians participating in the study with the introduction of the echOpen probe in the management of patients referred to the Jean Verdier UDR. | Physicians' satisfaction will also be assessed by a weekly questionnaire sent directly to them by the EchOpen team. | once a week throughout the entire inclusion period which is 16 months |
| To assess patient satisfaction with the introduction of the echOpen probe in the management of patients referred to the Jean Verdier UDR. | Patient satisfaction (phases 1 and 2) will be assessed by a questionnaire administered on discharge from the UDR. For Health Bus patients (phase 3), the questionnaire will be carried out at the Inclusion/Final visit. This questionnaire will include a visual analog scale to assess patients' overall satisfaction with the EchOpen. The scale ranges from 0 (very dissatisfied) to 10 (very satisfied). | Visit discharge from the RDU ( Maximum 2 months after inclusion visit) for pahse 1 and 2. At the Inclusion visit (day 1) for phase 3 |