Feasibility Study of a Patient-centered CDS for Recommended Screenings in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADER-F quantitative assessment, Individual semi directive interview with the patient, Individual semi directive interview or r Focus Group with the primary care professional.
- Who it may be relevant to
- Registry conditions: Primary Care. Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility Study of a Patient-centered Clinical Decision Support System for Recommended Screenings in Primary Care
Overview
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.
Interventions
- Other 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. - 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) - 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)
Primary outcome measures
- Lianeli SADM fully used [Time frame: Within 60 days of the inclusion consultation]
- Lianeli SADM fully used [Time frame: Within 60 days of the inclusion consultation]
- Lianeli SADM fully used [Time frame: Within 60 days of the inclusion consultation]
Secondary outcome measures (10)
- Feasibility criteria - GUIDES [Time frame: Within 60 days of the inclusion consultation]
- Feasibility crtiteria (Patient satisfaction questionnaire) [Time frame: Within 30 days after the dedicated screening consultation with the GP]
- Feasibility criteria (Primary care professional satisfaction questionnaire) [Time frame: Within 30 days after the dedicated screening consultation with the GP]
- Patient usability of Lianeli SADM [Time frame: Within 30 days after the dedicated screening consultation with the GP]
- Interprofessional use of the Lianeli SADM [Time frame: Within 60 days of the inclusion consultation]
- HLS-UE16 [Time frame: Within 60 days of the inclusion consultation]
- EPICES 11 [Time frame: Within 60 days of the inclusion consultation]
- Organized cancer screenings (breast, cervical and colorectal) [Time frame: Within 60 days of the inclusion consultation]
- Individual cancer screening [Time frame: Within 60 days]
- Feasibility criteria - metadata [Time frame: Within 60 days of the inclusion consultation]
Eligibility criteria
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-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 20 centers
- Cabinet médical — Belley
- Cabinet médical — Beynost
- CSCP - Centre de Santé Communautaire et Planétaire — Bron
- CSCP - Centre de Santé Communautaire et Planétaire — Bron
- CSCP - Centre de Santé Communautaire et Planétaire — Bron
- CSCP - Centre de Santé Communautaire et Planétaire — Bron
- Cabinet médical — Craponne
- MSP — Crêches-sur-Saône
- … and 12 more centers
Identifiers
NCT: NCT07270926 · 69HCL23_1126 · 2025-A00819-40