Feasibility Study of a Patient-centered CDS for Recommended Screenings in Primary Care

NCT ID: NCT07270926

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-07-01

Brief Summary

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Primary care professionals (PCPs) are responsible for identifying patients who are eligible for all recommended screenings. Eligibility is difficult, given the number of screenings recommended by the French National Authority for Health (HAS), and the complexity of defining risk groups. When eligibility for one or more screenings is identified, the PCP informs the patient and can help him or her make the decision, considering his or her values and preferences.

Lack of information for patients and lack of time for PCPs are the main obstacles to prevention in primary care (PC). Another barrier identified is the lack of opportunity for patients who do not consult their PCP very often, as they are less likely to be approached for preventive interventions due to other more urgent reasons for consultation.

A Medical Decision Support System (MDSS) is a software application designed to be a direct aid to clinical decision-making, in which an inference engine matches individual patient characteristics with a computerized knowledge base or machine-learning algorithm to propose a risk assessment or adapted recommendations to the healthcare professional and/or patient.

The aim of the ADER-F research program is to support the development and evaluation of a complex intervention centred on the use of a MDSS called "Lianeli".

This complex intervention will ultimately contribute to structuring new consultations dedicated to prevention in general practice, by improving the physician's sense of self-efficacy in conducting the shared screening decision, and reducing the patient's decision-making conflict.

Detailed Description

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Conditions

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Primary Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

non-comparative experimental feasibility study, in a prospective, multicenter regional phase in the context of primary care clinical practice in France
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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ADER-F

The Lianeli digital platform is a SADM produced by PREVENEAR. The Lianeli SADM is designed to facilitate the identification of patients' eligibility for screening recommended by the HAS (French National Authority for Health), and shared decision-making. It will be used by the patient through a health self-questionnaire and access to factual information sheets, then by the patient and GP during the consultation dedicated to prevention. All the examinations suggested by Lianeli are based on national recommendations, mainly from the HAS.

A mixed methodology was used, combining the quantitative component with a qualitative component involving semi-structured interviews with volunteer healthcare professionals and a sample of volunteer patients from among those included.

Group Type EXPERIMENTAL

ADER-F quantitative assessment

Intervention Type OTHER

The Lianeli SADM is designed to facilitate the identification of patients eligible for screenings recommended by the HAS (French National Authority for Health) and to facilitate shared decision-making during a primary care consultation dedicated to prevention.

The Lianeli SADM will be used by the patient first via a health questionnaire, then by the patient and the general practitioner during the consultation dedicated to prevention.

Individual semi directive interview with the patient

Intervention Type OTHER

24 Semi-structured individual interviews will be conducted with a sample of volunteer patients, one month after the end of their follow-up, by a psychologist specializing in qualitative studies.

The objective is to describe qualitatively the feasibility criteria for implementing the intervention according to the GUIDES checklist domains (A favorable context of use, appropriate content, a high-performance system, adequate implementation)

Individual semi directive interview or r Focus Group with the primary care professional

Intervention Type OTHER

Semi-structured individual interviews or focus groups with 24 primary care professionals will be conducted by a psychologist specializing in qualitative studies with a sample of volunteers, one month after the last patient's last visit to the center.

The objective is to describe qualitatively the feasibility criteria for implementing the intervention according to the GUIDES checklist domains (A favorable context of use, appropriate content, a high-performance system, adequate implementation)

Interventions

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ADER-F quantitative assessment

The Lianeli SADM is designed to facilitate the identification of patients eligible for screenings recommended by the HAS (French National Authority for Health) and to facilitate shared decision-making during a primary care consultation dedicated to prevention.

The Lianeli SADM will be used by the patient first via a health questionnaire, then by the patient and the general practitioner during the consultation dedicated to prevention.

Intervention Type OTHER

Individual semi directive interview with the patient

24 Semi-structured individual interviews will be conducted with a sample of volunteer patients, one month after the end of their follow-up, by a psychologist specializing in qualitative studies.

The objective is to describe qualitatively the feasibility criteria for implementing the intervention according to the GUIDES checklist domains (A favorable context of use, appropriate content, a high-performance system, adequate implementation)

Intervention Type OTHER

Individual semi directive interview or r Focus Group with the primary care professional

Semi-structured individual interviews or focus groups with 24 primary care professionals will be conducted by a psychologist specializing in qualitative studies with a sample of volunteers, one month after the last patient's last visit to the center.

The objective is to describe qualitatively the feasibility criteria for implementing the intervention according to the GUIDES checklist domains (A favorable context of use, appropriate content, a high-performance system, adequate implementation)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years and ≤74 years,
* Consultant to general practitioner,
* Without communication barriers in French, able to read and write
* Have signed the written consent form to participate in the study

Exclusion Criteria

* Under legal protection (guardianship, curatorship, safeguard of justice or deprived of liberty)
* with a psychiatric pathology or disorder with impaired judgment, as determined by the GP
* Pregnant or breast-feeding
* Not affiliated to a social security scheme or not benefiting from a similar scheme
* Participating in another clinical study that may interfere with the ADER-F study-
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cabinet médical

Belley, , France

Site Status

Cabinet médical

Beynost, , France

Site Status

CSCP - Centre de Santé Communautaire et Planétaire

Bron, , France

Site Status

CSCP - Centre de Santé Communautaire et Planétaire

Bron, , France

Site Status

CSCP - Centre de Santé Communautaire et Planétaire

Bron, , France

Site Status

CSCP - Centre de Santé Communautaire et Planétaire

Bron, , France

Site Status

Cabinet médical

Craponne, , France

Site Status

MSP

Crêches-sur-Saône, , France

Site Status

Maison de santé Gleizé Epinay

Gleizé, , France

Site Status

Groupe Médical Claude Bernard

LArbresle, , France

Site Status

Groupe Médical Claude Bernard

LArbresle, , France

Site Status

Cabinet médical

Lyon, , France

Site Status

Maison de Santé Beauvisage

Lyon, , France

Site Status

Maison de Santé Beauvisage

Lyon, , France

Site Status

Maison de Santé Beauvisage

Lyon, , France

Site Status

Maison de Santé Beauvisage

Lyon, , France

Site Status

Cabinet médcial

Saint-Pierre-la-Palud, , France

Site Status

MSP du Tissage

Tignieu, , France

Site Status

Cabinet médical

Villeurbanne, , France

Site Status

Maison de Santé Clos Caroline

Villeurbanne, , France

Site Status

Countries

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France

Central Contacts

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Laurent LETRILLIART

Role: CONTACT

(33) 478 777 286

Julien PERON

Role: CONTACT

(33) 478 862 339

Facility Contacts

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Stéphanie BARON-BERTRAND

Role: primary

Marie RODIER

Role: primary

Emmanuelle GUIMARAES

Role: primary

Benoit BLAES

Role: primary

Vanina ARIGAULT

Role: primary

COUSYN Cecile

Role: primary

Florent TRONEL

Role: primary

Alexandre BREST

Role: primary

Isabelle PLANUS

Role: primary

Taiana KEMPF LEMARCHAND

Role: primary

Claire Elise DEAL

Role: primary

Philippe VERMOREL

Role: primary

Pierre-Yves MEUNIER

Role: primary

(33) 478 744 685

Emmanuel VIRY

Role: primary

France BARDONNET

Role: primary

Lea ASTYL

Role: primary

Isabelle DURAND

Role: primary

Florian VALLE

Role: primary

Anne HERSART

Role: primary

Sophie SUN

Role: primary

Other Identifiers

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2025-A00819-40

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL23_1126

Identifier Type: -

Identifier Source: org_study_id

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