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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02183-46 | Registry Identifier | ID-RCB |
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This study, aimed at validating decision trees developed through collaboration between general practitioners and allergists, seeks to provide French data to optimize care pathways for patients with allergic diseases from the primary care level and to reduce the delays and negative consequences associated with incorrect diagnoses. Most patients with allergic conditions are initially seen in primary care, often during exacerbations. Although allergies, in their many clinical forms, account for approximately 6-8% of primary care consultations, clinicians frequently receive little or no formal training in this field and may not be fully aware of the latest evidence, associated risks, or appropriate referral pathways. These gaps can significantly affect the quality of care and patients' quality of life, while also contributing to higher morbidity and mortality. In this context, the European Academy of Allergy and Clinical Immunology established a multidisciplinary task force to transform existing allergy guidelines into simple, practical, and accessible tools to facilitate diagnosis and management in primary care. The group developed five decision trees covering asthma, anaphylaxis, drug allergy, food allergy, rhinitis, and urticaria to support primary care physicians and other non-specialists in managing patients with symptoms suggestive of allergic or hypersensitivity reactions. The results of this project will be directly applicable to the daily clinical practice of general practitioners in France and could serve as a model for replication in other regions and countries, although adaptations may be required depending on national healthcare systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | Patients consulting in participating centers after implementation of decision trees designed to support physicians in the diagnosis and management of allergic diseases |
|
| Non-interventional arm | No Intervention | Patients consulting in participating centers before implementation of clinical decision trees intended to support physicians in the diagnosis and management of allergic diseases. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation of an innovative tool based around AI-automated decision trees on an application | Other | The application provides immediate access to the algorithms (decision trees). Investigators can access a dedicated interface and enter participant data, including the suspected diagnosis, symptoms, acute episode or history of allergic disease, and the medical decision made (diagnosis, therapeutic management, or referral to a specialist). Management options based on the five algorithms are then generated to support physicians in the diagnosis and management of allergic diseases. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of referral to allergy specialists following primary care consultations for allergic diseases | Comparison of the proportion of patients referred to an allergy specialist by general practitioners after consultations for suspected allergic diseases before and after implementation of the clinical decision trees in participating centers. | through study completion, an average of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of use of the clinical decision trees | The ease of use of the clinical decision trees will be assessed using an online questionnaire completed by general practitioners at the end of their participation. The questionnaire will evaluate ease of use (score from 1 to 5, from very difficult to very easy), precision of the clinical decision trees (score from 1 to 5, from inaccurate to very precise), confidence felt during their application in clinical practice (score from 1 to 5, from not confident at all to totally confident), average duration of use (minutes), and willingness to continue using the clinical decision trees in routine practice (yes/no). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascal DEMOLY, Pr | Contact | +33467336107 | pascal.demoly@inserm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Msp Espace Sante Servian | Béziers | Occitanie | 34500 | France |
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Stepped-wedge cluster randomized study design. Participants are enrolled in 10 investigation centers. Centers (clusters), rather than individual participants, are randomized according to a stepped-wedge cluster design, with sequential implementation of the intervention at predefined time periods until all centers receive the intervention.
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| through study completion, an average of 4 years |
| MSP Universitaire Avicenne | Cabestany | Occitanie | 66330 | France |
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| Msp Montpellier -Cevenne | Montpellier | Occitanie | 34080 | France |
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| Msp Narbo Ouest | Narbonne | Occitanie | 11100 | France |
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| Msp Charles Gide | Nîmes | Occitanie | 30000 | France |
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| Msp Beau Art | Perpignan | Occitanie | 66000 | France |
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| MSP Calypso | Roujan | Occitanie | 34320 | France |
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| Département Universitaire de Médecine Générale MSPU CHU Montpellier | Saint-Georges-dOrques | Occitanie | 34680 | France |
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| Msp Sud Minevoir | Saint-Marcel-sur-Aude | Occitanie | 11120 | France |
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| MSP Pézenas-Tourbes | Tourbes | Occitanie | 34120 | France |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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