"Clinical Ultrasound, a New Link Between Town and Hospital in Seine-Saint-Denis". (ECHO93)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Clinical Ultrasound; Diagnosis

Treatments: Device: Echoscopy examination using the echOpen probe

Study type: Interventional

Funder types: Other

Identifiers

NCT06774924

APHP 240421

N° IDRCB: 2024-A (Other Identifier)

Details and patient eligibility

About

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.

Full description

This research will be carried out in 3 phases:

• Phase 1: implementation of the tool within the hospital for UDR doctors and evaluation of the effect of this implementation on the organizations: shorter time to diagnosis, increased accuracy of diagnosis, reduced number of complementary examinations. This first phase will begin with EchOpen training for doctors, and will continue with inclusions and testing of the added value of using the probe within the UDR.
• Phase 2: implementation of the tool in the structures referring patients to the UDR, whether the SAU de Jean Verdier, for clearing before referral to the UDR, or the structures of town doctors (CPTS Livry Gargan, MSP Pantin and Cabinet Médical du Dr TAYBALY at Aulnay-sous-Bois) for clearing before referral to the UDR. As in phase 1, the aim is to assess the effect of the new approach on organization, and to report on follow-up indicators, such as the number of patients with direct access to biopsy, the reduction in diagnosis time, and the targeting and reduction of additional examinations. This second phase will begin one month after phase 1, starting with EchOpen training for doctors and continuing with inclusions and experimentation within the adult emergency departments of Jean Verdier Hospital and the multi-professional health centers named above.
• Phase 3: implementation of the tool in the Health Bus, as part of the "go-to" approach. The monitoring indicator will be the number of situations in which the echOpen solution has made it possible to sort between pathologies that require an emergency service or that can be managed in the Health Bus. This third phase will begin one month after phase 2, starting with EchOpen training for doctors and continuing with inclusions and testing of the probe in the Health Bus.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patient over 18 years of age

2. Patient with signed informed consent

3. Patient managed by:

   • one of the structures involved (UDR/ SAU Jean Verdier, MSP Pantin, Cabinet Médical du Dr TAYBALY à Aulnay-sous-Bois) for referral to the UDR for rapid diagnosis (phases 1 and 2)
   • the Health Bus (phase 3)

Exclusion criteria

1. Patient on the UDR iron-deficiency anemia clinical pathway

2. Patient deprived of liberty by judicial or administrative decision

3. Patient who does not speak French and cannot benefit from the presence of a relative or translator (physical or online)

4. Patient with a contraindication to the use of EchOPen:

   • patients with a body mass index greater than 34.9 kg/m2
   • life-threatening patients requiring emergency medical care.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

echoscopy examination using the echOpen probe

Other group

Description:

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).

Treatment:

Device: Echoscopy examination using the echOpen probe