Implementation of a Clinical Decision Support System in Primary Care for the Screening and Assessment of Frailty in Patients Aged 65 and Over (FRAGICLIC)
Implementation of a Clinical Decision Support System in Primary Care for the Screening and Assessment of Frailty in Patients Aged 65 and Over: A Real-World Prospective Cohort Study
This observational study aims to evaluate the real-life use of a digital tool (Fragiclic) by general practitioners (GPs) and nurses to screen and assess frailty in adults aged 65 and over. Frailty is a syndrome that increases the risk of loss of autonomy, falls, hospitalizations, or death. The tool includes simple screening questionnaires (such as SEGAm) and a comprehensive assessment (CGA - Comprehensive Geriatric Assessment) to better manage patients' health.
The main question it aims to answer is:
- What proportion of patients aged 65 and over will benefit from frailty screening or assessment using Fragiclic over 12 months?
A secondary question is
- Does the use of Fragiclic reduce the risk of unplanned hospitalizations or death in these patients?
For the secondary question, researchers will compare patients who received screening or assessment (with or without a Personalized Care Plan (PCP)) to those who did not, to determine if Fragiclic improves their health outcomes.
Participants will not have additional tasks: Their GP or nurse will use Fragiclic during routine consultations. Some patients may be asked to provide information about their health or quality of life (via their healthcare provider).
All data will be collected anonymously and securely
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Léon BANH, Dr
- 电话号码:01 60 17 65 65
- 邮箱:leon.banh@u-pec.fr
研究联系人备份
- 姓名:Fazia chelli, Mrs
- 邮箱:f.chelli@cnge.fr
学习地点
-
-
Rue Charlie-Chaplin
-
Torcy、Rue Charlie-Chaplin、法国、77200
- MSPU Torcy
-
接触:
- Léon Banh
- 电话号码:01 60 17 65 65
- 邮箱:leon_banh@hotmail.fr
-
-
参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Patients aged 65 years or older
- Patient or trusted person who provided oral non-opposition after receiving full information about the protocol
- Managed by the general practitioner if the patient or nurse during the study period. If patients are assessed by a nurse : Patients whose general practitioner is a participating physician in the study
Exclusion Criteria:
- Patients unable to express non-opposition or without a trusted person available to express non-opposition
- Patients whose general practitioner (GP) is not a participating GP in the study
- Patients or trusted persons who do not speak French
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan
大体时间:From patient enrollment to the end of follow-up at 12+/-1 months
|
This includes the implementation of a screening and/or assessment, whether complete or incomplete (incomplete grid and/or incomplete or not performed PCP)
|
From patient enrollment to the end of follow-up at 12+/-1 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rates of all-cause mortality and unplanned hospitalizations among patients included in the study
大体时间:From patient enrollment to the end of follow-up at 12+/-1 months
|
The rates of all-cause mortality and unplanned hospitalizations among patients included in the study, based on whether they underwent screening or assessment (complete or incomplete implementation) versus no implementation, and according to the assessment tool used within the Fragiclic site (SEGAm alone +/- PCP vs. CGA alone +/- PCP vs. SEGAm+CGA +/- PCP)
|
From patient enrollment to the end of follow-up at 12+/-1 months
|
|
Number, percentage, and type of personalized care plans prescribed based on the tool used and the degree of PCP implementation
大体时间:at 3 months after prescription
|
Number, percentage, and type of personalized care plans (PPS) prescribed based on the tool used (SEGAm alone vs. EGS alone vs. SEGAm + EGS), and the degree of PPS implementation (actions implemented)
|
at 3 months after prescription
|
|
Acceptability of the use of the Fragiclic platform among healthcare professionals (HCP) who are users and non-users
大体时间:at the end of patients follow-up, 12 months after enrollment
|
Feasibility (number of SEGAm, EGS, and PPS completed by users, completion time, patient refusals, number of users, and monthly logins) Perceived satisfaction with the use of the tool (qualitative study) Perceived usefulness of the tool (actions implemented, observed health outcomes) (qualitative study) Perceived difficulties in screening, frailty assessment, and implementing care and support actions (qualitative study)
|
at the end of patients follow-up, 12 months after enrollment
|
|
Socio-demographic profiles of healthcare professionals (HCP) who are users and non-users (age, gender, mode of practice) and usage profiles (number of logins, SEGAm, EGS, and PPS completed, average usage duration)
大体时间:at the end of patients follow-up, 12 months after enrollment
|
Socio-demographic profiles : age, gender, mode of practice Usage profile : number of logins, SEGAm, CGA, and PCP completed, average usage duration
|
at the end of patients follow-up, 12 months after enrollment
|
|
Number and percetange of complete implementation (patients with complete screening or assessment: complete frailty assessment grid and complete PPS)
大体时间:at the end of patients follow-up, 12 months after enrollment
|
Complete implementation = patients with complete screening or assessment: complete frailty assessment grid and complete PPS
|
at the end of patients follow-up, 12 months after enrollment
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2025-A00640-49
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.