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

Study Overview

• Status: Not yet recruiting
• Conditions: Geriatric Assessment; Primary Care; Implementation Research; Frailty at Older Adults; Interprofessional Collaboration

• Study Type: Observational
• Enrollment (Estimated): 726

Contacts and Locations

• Study Contact: Name: Léon BANH, Dr; Phone Number: 01 60 17 65 65; Email: leon.banh@u-pec.fr
• Study Contact Backup: Name: Fazia chelli, Mrs; Email: f.chelli@cnge.fr

Study Locations

• France
  • Rue Charlie-Chaplin
    • Torcy, Rue Charlie-Chaplin, France, 77200
      • MSPU Torcy
      • Contact: Léon Banh; Phone Number: 01 60 17 65 65; Email: leon_banh@hotmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 years older among GP's patients in primary care

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who have benefited from at least one screening or frailty assessment associated with a personalized care plan	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of all-cause mortality and unplanned hospitalizations among patients included in the study	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	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	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)	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)	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

Collaborators and Investigators

• Sponsor: CNGE Conseil

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): January 2, 2029

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-A00640-49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No