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Primary CareADER-FNCT07270926

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

A study testing ADER-F quantitative assessment, Individual semi directive interview with the patient and Individual semi directive interview or r Focus Group with the primary care professional in people with Primary Care, run by Hospices Civils de Lyon at 20 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 yearsHealthy volunteers can take part
Conditions the study is for
Primary Care
What is being tested?
ADER-F quantitative assessment, Individual semi directive interview with the patient and Individual semi directive interview or r Focus Group with the primary care professional
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
20 sitesFrance
Study dates
6 Mar 2026to 6 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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-

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

20 sites in 1 country

France20 sites, 20 recruiting
  • Cabinet médical

    Belley, 01300

    Stéphanie BARON-BERTRAND, dr.baron.stephanie@gmail.com

    Recruiting
  • Cabinet médical

    Beynost, 01700

    Marie RODIER, drmrodier@gmail.com

    Recruiting
  • CSCP - Centre de Santé Communautaire et Planétaire

    Bron, 69005

    Emmanuelle GUIMARAES, emmanuelle.guimaraes@cscp-bron.fr

    Not yet recruiting
  • CSCP - Centre de Santé Communautaire et Planétaire

    Bron, 69005

    Benoit BLAES, benoit.blaes@cscp-bron.fr

    Not yet recruiting
  • CSCP - Centre de Santé Communautaire et Planétaire

    Bron, 69005

    Vanina ARIGAULT, vanina.arigault@cscp-bron.fr

    Not yet recruiting
  • CSCP - Centre de Santé Communautaire et Planétaire

    Bron, 69500

    COUSYN Cecile, cecile.cousyn@cscp-bron.fr

    Not yet recruiting
  • Cabinet médical

    Craponne, 69290

    Florent TRONEL, docteur.tronel@gmail.com

    Not yet recruiting
  • MSP

    Crêches-sur-Saône, 71680

    Alexandre BREST, drbrest@orange.fr

    Recruiting
  • Maison de santé Gleizé Epinay

    Gleizé, 69400

    Isabelle PLANUS, planusisabelle@gmail.com

    Recruiting
  • Groupe Médical Claude Bernard

    LArbresle, 69210

    Taiana KEMPF LEMARCHAND, Taiana.kempf@gmail.com

    Recruiting
  • Groupe Médical Claude Bernard

    LArbresle, 69210

    Claire Elise DEAL, clarie.elise.deal@gmail.com

    Recruiting
  • Cabinet médical

    Lyon, 69008

    Philippe VERMOREL, dr.vermorel@orange.fr

    Not yet recruiting
  • Maison de Santé Beauvisage

    Lyon, 69008

    Pierre-Yves MEUNIER, (33) 478 744 685, pierre-yves.meunier@univ-lyon1.fr

    Recruiting
  • Maison de Santé Beauvisage

    Lyon, 69008

    Emmanuel VIRY

    Not yet recruiting
  • Maison de Santé Beauvisage

    Lyon, 69008

    France BARDONNET, francecharvet@hotmail.com

    Recruiting
  • Maison de Santé Beauvisage

    Lyon, 69008

    Lea ASTYL, lea.astyl@gmail.com

    Not yet recruiting
  • Cabinet médcial

    Saint-Pierre-la-Palud, 69210

    Isabelle DURAND, ifuvel@gmail.com

    Recruiting
  • MSP du Tissage

    Tignieu, 38230

    Florian VALLE, florian.valle096@hotmail.fr

    Recruiting
  • Cabinet médical

    Villeurbanne, 69100

    Anne HERSART, anne.hdlv@gmail.com

    Recruiting
  • Maison de Santé Clos Caroline

    Villeurbanne, 69100

    Sophie SUN, sophie.sun@univ-lyon1.fr

    Recruiting

Other trials in France

About this study

Official title: Feasibility Study of a Patient-centered Clinical Decision Support System for Recommended Screenings in Primary Care

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.

Read more

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
Being tested
ADER-F quantitative assessment, Individual semi directive interview with the patient, Individual semi directive interview or r Focus Group with the primary care professional
Keywords
Primary care, Recommended screening, Medical Decision Support System (MDSS), patient-centered Clinical Decision Support (CDS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADER-F quantitative assessmentOther

    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 patientOther

    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 professionalOther

    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)

Study groups in NCT07270926
Study groupRoleWhat they receive
ADER-FExperimentalThe 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Within 60 days of the inclusion consultation

  2. 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)

    Measured: Within 60 days of the inclusion consultation

  3. 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)

    Measured: Within 60 days of the inclusion consultation

Secondary outcomes (10)
  1. Feasibility criteria - GUIDES

    Describe quantitatively the feasibility criteria for the implementation of the ADER-F intervention according to the GUIDES checklist domains.

    The checklist GUIDES is the standard for evaluating indicators that promote the implementation of an CDS (computerized decision support) system based on clinical practice recommendations. According to this guide, indicators evenly distributed across four areas (a favorable context for use, an appropriate content, an effective system, a proper implementation) determine the success of an CDS system implementation. Questionnaire GUIDES consists of 12 items distributed across this four areas. Each item is scored using a 7-point Likert scale. Responses were code as follows : 1 for strongly disagree, 2 for disagree, 3 for somewhat disagree, 4 for undecided, 5 for somewhat agree, 6 for agree, 7 for strongly agree.

    The scores per domain are the average of the scores assigned to the various items comprising each domain (range 1 to 7). Domains with l

    Measured: Within 60 days of the inclusion consultation

  2. Feasibility crtiteria (Patient satisfaction questionnaire)

    Describe quantitatively the feasibility criteria for the implementation of the ADER-F intervention according to the GUIDES checklist domains using patient satisfaction questionnaire (12 items - 7-point Likert scale).

    The satisfaction questionnaire is interpreted according to the areas of the GUIDES Check List. According to this guide, 16 indicators, evenly distributed across 4 areas, determine the success of implementing a SADM (Simplified Access Management System). These four areas lead researchers to ensure that the context of use is favorable, the content appropriate, the system efficient, and the implementation adequate.

    Measured: Within 30 days after the dedicated screening consultation with the GP

  3. Feasibility criteria (Primary care professional satisfaction questionnaire)

    Describe quantitatively the feasibility criteria for the implementation of the ADER-F intervention according to the areas GUIDES checklist domains using primary care professional questionnaire (11 items - 7-point Likert scale)

    Measured: Within 30 days after the dedicated screening consultation with the GP

  4. Patient usability of Lianeli SADM

    Assessment of the Lianeli SADM user experience (patient and Primary care professional) using the SUS scale The System Usability Scale (SUS) is a questionnaire for measuring the usability of interactive systems, comprising ten items formulated in the form of affirmative sentences. For each sentence, users are asked to express their agreement or disagreement, using a 5-point Lickert scale.

    Assessment of the Lianeli SADM user experience (patient and Primary care professional) using the SUS scale The System Usability Scale (SUS) is a questionnaire for measuring the usability of interactive systems, comprising ten items formulated in the form of affirmative sentences. For each sentence, users are asked to express their agreement or disagreement, using a 5-point Lickert scale. The results of the SUS questionnaire are used to calculate the satisfaction score. This score ranges from 1 to 100. A score of 75 or above is generally considered "good," while a score between 50 and 75 is considered

    Measured: Within 30 days after the dedicated screening consultation with the GP

  5. Interprofessional use of the Lianeli SADM

    To assess the effect of interprofessional use of the Lianeli SADM on the primary endpoint.

    Interprofessional work will be defined as the collaboration of at least two healthcare professionals (including the general practitioner) with the patient as part of the ADER-F intervention

    Measured: Within 60 days of the inclusion consultation

  6. HLS-UE16

    To assess the effect of patients' health literacy on the primary endpoint. Health literacy will be assessed using the HLS-EU16 (European Health Literacy Survey Questionnaire). This questionnaire comprises 16 questions using a 5-point Likert scale. The HLS-EU16 L scale assesses one dimension of health literacy in the general population. The French version of the HLS-EU-Q16 has acceptable psychometric properties.

    European Health Literacy Survey Questionnaire (Erreur dans proto - échelle Likert en 4 points) The results of the HLS-EU16 scale reveal the health literacy levels of the participants. Responses were coded as follows: 0 for "quite difficult" and "very difficult," and 1 for "quite easy" and "very easy." The total score, which ranges from 0 to 16, allows participants' health literacy to be classified into three levels: Inadequate (0-8), Problematic (9-12), Sufficient (13-16)

    Measured: Within 60 days of the inclusion consultation

  7. EPICES 11

    EPICES : Assessment of Precarity and Health Inequalities in Health Examination Centers To assess the effect of patients' precariousness and health inequalities on the primary outcome.

    Health insecurity will be assessed using the EPICES scale. This questionnaire is an individual indicator of precariousness that considers the multidimensional nature of precariousness. It consists of 11 binary yes/no questions. The answer to each question is assigned a coefficient, and the sum of the 11 answers gives the EPICES score. The score is continuous, ranging from 0 (absence of precariousness) to 100 (maximum precariousness). A single score of 30.17 is considered relevant.

    Measured: Within 60 days of the inclusion consultation

  8. Organized cancer screenings (breast, cervical and colorectal)

    The proportion of patients for whom the intervention is likely to improve participation in the three organized cancer screenings (colorectal, breast, cervical) will be assessed within the population of patients identified as eligible for at least one of the three organized screenings (previous examination performed within a timeframe greater than the recommended timeframe, or never performed) by the proportion of patients who attended the dedicated screening consultation within 60 days of the inclusion consultation.

    Measured: Within 60 days of the inclusion consultation

  9. Individual cancer screening

    The proportion of patients for whom the intervention is likely to improve participation in opportunistic cancer screening will be assessed within the population of patients identified as eligible for at least one of the opportunistic cancer screenings (high-risk colorectal cancer, high-risk breast cancer, high-risk stomach cancer - previous examination performed within a timeframe greater than the recommended timeframe or never performed) by the proportion of patients who attended the dedicated screening consultation within 60 days of the inclusion consultation.

    Measured: Within 60 days

  10. Feasibility criteria - metadata

    Describe quantitatively the feasibility criteria for the implementation of the ADER-F intervention from Lianeli usage metadata

    Measured: Within 60 days of the inclusion consultation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start6 Mar 2026
  3. Primary completion6 Mar 2027 (estimated)
  4. Study completion6 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
non-comparative experimental feasibility study, in a prospective, multicenter regional phase in the context of primary care clinical practice in France
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07270926
Sponsor's protocol ID
69HCL23_1126
Other IDs
2025-A00819-40
Acronym
ADER-F
Status last verified
Mar 2026
First submitted
10 Sep 2025
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Meunier PY, Magaud L, Varnier R, Goetz E, Bekaddour M, Albert L, Khati I, Bensekka I, Haesebaert J, Maillet D, Peron J, Letrilliart L. Patient-Centered Clinical Decision Support for Recommended Screenings in French Primary Care: Protocol for a Multicenter Mixed Methods Feasibility Study. JMIR Res Protoc. 2026 Sep 3;15:e89922. doi: 10.2196/89922.

    PubMed 42691486

Questions about this trial

What is this clinical trial studying?

A study testing ADER-F quantitative assessment, Individual semi directive interview with the patient and Individual semi directive interview or r Focus Group with the primary care professional in people with Primary Care, run by Hospices Civils de Lyon at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laurent LETRILLIART ((33) 478 777 286, laurent.letrilliart@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lianeli SADM fully used (time frame: Within 60 days of the inclusion consultation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07270926, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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