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

NCT07270926 | Not Yet Recruiting

• 2 other identifiers: 69HCL23_11262025-A00819-40
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Primary Care

Keywords

Primary care; Recommended screening; Medical Decision Support System (MDSS); patient-centered Clinical Decision Support (CDS)

Outcome Measures

Primary Outcomes (3)

• Lianeli SADM fully used

  The primary outcome is a composite criterion. This composite criterion is the proportion of patients with full use of the Lianeli SADM. A "yes" answer to the three following items defines full use of the Lianeli SADM: * Validation by the patient of their answers to the Lianeli health questionnaire (yes/no) * Validation by the general practitioner of the patient's responses to the Lianeli health questionnaire (yes/no) * Completion of the consultation dedicated to screening (yes/no)

  Within 60 days of the inclusion consultation

• Lianeli SADM fully used

  Proportion of patients included for whom the Lianeli SADM was fully used : Verification of the questionnaire by the GP (validate/not validated)

  Within 60 days of the inclusion consultation

• Lianeli SADM fully used

  Proportion of patients included for whom the Lianeli SADM was fully used : Dedicated screening consultation with the GP (done/not done)

  Within 60 days of the inclusion consultation

Secondary Outcomes (10)

• Feasibility criteria - GUIDES

  Within 60 days of the inclusion consultation

• Feasibility crtiteria (Patient satisfaction questionnaire)

  Within 30 days after the dedicated screening consultation with the GP

• Feasibility criteria (Primary care professional satisfaction questionnaire)

  Within 30 days after the dedicated screening consultation with the GP

• Patient usability of Lianeli SADM

  Within 30 days after the dedicated screening consultation with the GP

• Interprofessional use of the Lianeli SADM

  Within 60 days of the inclusion consultation

Study Arms (1)

ADER-F

EXPERIMENTAL

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.

Other: ADER-F quantitative assessment; Other: Individual semi directive interview with the patient; Other: Individual semi directive interview or r Focus Group with the primary care professional

Interventions

ADER-F quantitative assessment 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.

ADER-F

Individual semi directive interview with the patient 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)

ADER-F

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

ADER-F

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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-

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (20)

Cabinet médical

Belley, 01300, France

Location

Cabinet médical

Beynost, 01700, France

Location

CSCP - Centre de Santé Communautaire et Planétaire

Bron, 69005, France

Location

CSCP - Centre de Santé Communautaire et Planétaire

Bron, 69005, France

Location

CSCP - Centre de Santé Communautaire et Planétaire

Bron, 69005, France

Location

CSCP - Centre de Santé Communautaire et Planétaire

Bron, 69500, France

Location

Cabinet médical

Craponne, 69290, France

Location

MSP

Crêches-sur-Saône, 71680, France

Location

Maison de santé Gleizé Epinay

Gleizé, 69400, France

Location

Groupe Médical Claude Bernard

LArbresle, 69210, France

Location

Groupe Médical Claude Bernard

LArbresle, 69210, France

Location

Cabinet médical

Lyon, 69008, France

Location

Maison de Santé Beauvisage

Lyon, 69008, France

Location

Maison de Santé Beauvisage

Lyon, 69008, France

Location

Maison de Santé Beauvisage

Lyon, 69008, France

Location

Maison de Santé Beauvisage

Lyon, 69008, France

Location

Cabinet médcial

Saint-Pierre-la-Palud, 69210, France

Location

MSP du Tissage

Tignieu, 38230, France

Location

Cabinet médical

Villeurbanne, 69100, France

Location

Maison de Santé Clos Caroline

Villeurbanne, 69100, France

Location

Central Study Contacts

Laurent LETRILLIART

CONTACT

(33) 478 777 286; laurent.letrilliart@univ-lyon1.fr

Julien PERON

CONTACT

(33) 478 862 339; julien.peron@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-comparative experimental feasibility study, in a prospective, multicenter regional phase in the context of primary care clinical practice in France

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

FR (20)