Feasibility Study of a Patient-centered CDS for Recommended Screenings in Primary Care (ADER-F)

March 30, 2026 updated by: Hospices Civils de Lyon

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Belley, France, 01300
      • Beynost, France, 01700
      • Bron, France, 69005
      • Bron, France, 69500
        • Not yet recruiting
        • CSCP - Centre de Santé Communautaire et Planétaire
        • Contact:
      • Craponne, France, 69290
      • Crêches-sur-Saône, France, 71680
      • Gleizé, France, 69400
      • LArbresle, France, 69210
      • Lyon, France, 69008
      • Lyon, France, 69008
      • Lyon, France, 69008
      • Saint-Pierre-la-Palud, France, 69210
      • Tignieu, France, 38230
        • Recruiting
        • MSP du Tissage
        • Contact:
          • Florian VALLE
          • Phone Number: florian.valle096@hotmail.fr
      • Villeurbanne, France, 69100
      • Villeurbanne, France, 69100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lianeli SADM fully used
Time Frame: Within 60 days of the inclusion consultation

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
Time Frame: Within 60 days of the inclusion consultation

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
Time Frame: Within 60 days of the inclusion consultation

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility criteria - GUIDES
Time Frame: Within 60 days of the inclusion consultation

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
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

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.
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
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)
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

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
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

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
Within 60 days of the inclusion consultation
HLS-UE16
Time Frame: Within 60 days of the inclusion consultation

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)
Within 60 days of the inclusion consultation
EPICES 11
Time Frame: Within 60 days of the inclusion consultation

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.
Within 60 days of the inclusion consultation
Organized cancer screenings (breast, cervical and colorectal)
Time Frame: Within 60 days of the inclusion consultation
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.
Within 60 days of the inclusion consultation
Individual cancer screening
Time Frame: Within 60 days
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.
Within 60 days
Feasibility criteria - metadata
Time Frame: Within 60 days of the inclusion consultation
Describe quantitatively the feasibility criteria for the implementation of the ADER-F intervention from Lianeli usage metadata
Within 60 days of the inclusion consultation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Estimated)

March 6, 2027

Study Completion (Estimated)

March 6, 2027

Study Registration Dates

First Submitted

September 10, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL23_1126
  • 2025-A00819-40 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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