Feasibility Study of a Patient-centered CDS for Recommended Screenings in Primary Care
ConditionPrimary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorHospices Civils de Lyon
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ADER-F quantitative assessment
Other interventionThe 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
Other intervention24 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
Other interventionSemi-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)
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: ADER-FExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
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)
Time frame
Within 60 days of the inclusion consultation2
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)
Time frame
Within 60 days of the inclusion consultation3
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)
Time frame
Within 60 days of the inclusion consultationSecondary outcomes
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
Time frame
Within 60 days of the inclusion consultation2
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.
Time frame
Within 30 days after the dedicated screening consultation with the GP3
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)
Time frame
Within 30 days after the dedicated screening consultation with the GP4
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
Time frame
Within 30 days after the dedicated screening consultation with the GPSponsors and contacts
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Source ClinicalTrials.gov