Feasibility Study of a Patient-centered Clinical Decision Support System for Recommended Screenings in Primary Care
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 23
- 主要终点
- Lianeli SADM fully used
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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-
研究组 & 干预措施
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.
干预措施: ADER-F quantitative assessment (Other)
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.
干预措施: Individual semi directive interview with the patient (Other)
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.
干预措施: Individual semi directive interview or r Focus Group with the primary care professional (Other)
结局指标
主要结局
Lianeli SADM fully used
时间窗: 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)
次要结局
- Feasibility criteria - GUIDES(Within 60 days of the inclusion consultation)
- Feasibility crtiteria (Patient satisfaction questionnaire)(Within 30 days after the dedicated screening consultation with the GP)
- Feasibility criteria (Primary care professional satisfaction questionnaire)(Within 30 days after the dedicated screening consultation with the GP)
- Patient usability of Lianeli SADM(Within 30 days after the dedicated screening consultation with the GP)
- Interprofessional use of the Lianeli SADM(Within 60 days of the inclusion consultation)
- HLS-UE16(Within 60 days of the inclusion consultation)
- EPICES 11(Within 60 days of the inclusion consultation)
- Organized cancer screenings (breast, cervical and colorectal)(Within 60 days of the inclusion consultation)
- Individual cancer screening(Within 60 days)
- Feasibility criteria - metadata(Within 60 days of the inclusion consultation)