Optimizing Access to Care Through New Technologies: a Randomized Study Evaluating the Impact of Telephone Contact and the Sending by the General Practitioner of Suspicious Lesions Melanoma Photographs Taken With a Smartphone, on the Time Limit to the Consultation With a Dermatologist

NCT03137511 | Completed

• 1 other identifier: RC16_0033
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Early detection of melanoma showed an impact on the thickness of the lesions at the time of diagnosis. One challenge is to improve the modalities. Decrease the rate of non-compliant patients among patients referred to the dermatologist for a suspicious lesion (patients who will never go to the consultation), and reduce the time interval between the first identification of the lesion and the excision allowing the diagnosis are major issues. Direct contact between the general practitioner (GP) and the dermatologist would probably make it possible to shorten the care pathway of patients with lesions justifying excision. The objective is to evaluate whether contacting the dermatologist directly by telephone and e-mailing the photograph of a suspicious melanoma lesion can significantly reduce the time required for access to the consultation for the following patients: (a) referred for a suspicious lesion of melanoma by the GP (b) and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision (true positives). Expected results: The procedure should shorten the care pathway for patients with melanoma and decrease the proportion of patients who do not consult the dermatologist when they were referred ("non-observing patients"). This should facilitate the identification of thinner lesions. The benefit for the patient is then direct with a survival at 5 years higher. In public health terms, it is expected a benefit as better optimization of resources. In a situation of shortage of professionals, access to the dermatologist should be optimized by optimizing emergency access for patients who require it.

Conditions

Patients at Risk for Melanoma

Keywords

Public Health; General Medicine; Dermatology

Outcome Measures

Primary Outcomes (1)

• Time limit for consultation general practitioner / dermatologist, patients having a sufficiently suspicious lesion of melanoma

  Time limit for consultation between consultation of the general practitioner and consultation with the dermatologist, for patients: 1. referred for a suspicious lesion of melanoma by the general practitioner, 2. and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision

  12 months

Secondary Outcomes (2)

• Time limit for consultation general practitioner / dermatologist, patients NOT having a sufficiently suspicious lesion of melanoma

  12 months

• "Non-observing" patients between the 2 randomization groups

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

General practitioners will be invited to screen for melanoma as part of their regular consultations. * The MG collects relevant clinical information * The MG takes 2 photographs of the lesion with his smartphone. * The MG sends to the dermatologist by e-mail the 2 photographs of the lesion accompanied by relevant clinical information * The MG calls the secretariat of the dermatologist to record the admissibility of the mail, to give the identity and the coordinates of the patient whose photos have just been sent and to obtain an appointment. * The dermatologist proposes an appointment to the patient.

Other: Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist

Control group

NO INTERVENTION

General practitioners will be invited to screen for melanoma as part of their regular consultations. General practitioners and dermatologists continue their practice in the usual way.

Interventions

Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist OTHER

Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• Consulting a general practitioner participating in the study,
• Having a suspicious cutaneous lesion of melanoma according to the MG,
• Referred to a dermatologist who agreed to participate in the study,
• \> = 18 years of age, with written informed consent,
• Affiliated to a social security scheme

You may not qualify if:

• Patients:
• Consulting a general practitioner who does not participate in the study,
• Having no suspect melanoma lesion according to MG,
• Referred to the dermatologist for symptoms or pathologies unrelated to a suspicion of melanoma
• Wishing to consult a dermatologist who refused to participate in the study,
• Refusing the transmission by mail of 2 anonymised photos,
• \<18 years of age, or with no written informed consent.
• Major under tutelage, under curatorship

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, France

Location

Related Publications (1)

• Bouton C, Schmeltz H, Leveque C, Gaultier A, Quereux G, Dreno B, Nguyen JM, Rat C. Early diagnosis of melanoma: a randomized trial assessing the impact of the transmission of photographs taken with a smartphone from the general practitioner to the dermatologist on the time to dermatological consultation. BMC Health Serv Res. 2024 May 24;24(1):660. doi: 10.1186/s12913-024-11106-9.

  PMID: 38783296 DERIVED

Study Design

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

Model Details: Cluster randomization of MGs corresponding to their exercise sites

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 2, 2017
• Study Start: May 23, 2017
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)