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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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)
• Другое 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)

Первичные конечные точки

• Lianeli SADM fully used [Срок оценки: Within 60 days of the inclusion consultation]
• Lianeli SADM fully used [Срок оценки: Within 60 days of the inclusion consultation]
• Lianeli SADM fully used [Срок оценки: Within 60 days of the inclusion consultation]

Вторичные конечные точки (10)

• Feasibility criteria - GUIDES [Срок оценки: Within 60 days of the inclusion consultation]
• Feasibility crtiteria (Patient satisfaction questionnaire) [Срок оценки: Within 30 days after the dedicated screening consultation with the GP]
• Feasibility criteria (Primary care professional satisfaction questionnaire) [Срок оценки: Within 30 days after the dedicated screening consultation with the GP]
• Patient usability of Lianeli SADM [Срок оценки: Within 30 days after the dedicated screening consultation with the GP]
• Interprofessional use of the Lianeli SADM [Срок оценки: Within 60 days of the inclusion consultation]
• HLS-UE16 [Срок оценки: Within 60 days of the inclusion consultation]
• EPICES 11 [Срок оценки: Within 60 days of the inclusion consultation]
• Organized cancer screenings (breast, cervical and colorectal) [Срок оценки: Within 60 days of the inclusion consultation]
• Individual cancer screening [Срок оценки: Within 60 days]
• Feasibility criteria - metadata [Срок оценки: Within 60 days of the inclusion consultation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 20 центров

• 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
• … и ещё 12 центров

Идентификаторы

NCT: NCT07270926 · 69HCL23_1126 · 2025-A00819-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗