LOGOGRAM: Validation of Allergy Care Flowcharts in Primary Care: Experience From Occitanie

NCT07631039 | Not Yet Recruiting

• 2 other identifiers: RECHMPL23_03272025-A02183-46
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Allergy

Keywords

diagnosis; general practitioner; flowchart; care pathway

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Ease of use of the clinical decision trees

  through study completion, an average of 4 years

Study Arms (2)

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

Other: Implementation of an innovative tool based around AI-automated decision trees on an application

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.

Interventions

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.

Interventional arm

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected asthma, anaphylaxis, drug allergy, food allergy, rhinitis and urticaria.
• Patient or legal representative of the minor patient who agrees to participate in the research.

You may not qualify if:

• Adults placed under guardianship or curatorship.
• Patients already followed by an allergist and/or a specialist doctor for their allergies.
• Patients who participate in a clinical research study relating to an antiallergic medication, immunosuppressant, immunomodulator in the year preceding their consultation visit with the GP.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (10)

Msp Espace Sante Servian

Béziers, Occitanie, 34500, France

Location

MSP Universitaire Avicenne

Cabestany, Occitanie, 66330, France

Location

Msp Montpellier -Cevenne

Montpellier, Occitanie, 34080, France

Location

Msp Narbo Ouest

Narbonne, Occitanie, 11100, France

Location

Msp Charles Gide

Nîmes, Occitanie, 30000, France

Location

Msp Beau Art

Perpignan, Occitanie, 66000, France

Location

MSP Calypso

Roujan, Occitanie, 34320, France

Location

Département Universitaire de Médecine Générale MSPU CHU Montpellier

Saint-Georges-dOrques, Occitanie, 34680, France

Location

Msp Sud Minevoir

Saint-Marcel-sur-Aude, Occitanie, 11120, France

Location

MSP Pézenas-Tourbes

Tourbes, Occitanie, 34120, France

Location

MeSH Terms

Conditions

Hypersensitivity; Disease

Condition Hierarchy (Ancestors)

Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pascal DEMOLY, Pr

CONTACT

+33467336107; pascal.demoly@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 5, 2026

Record last verified: 2026-05

Locations

FR (10)