Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study (evAB)

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05303350
Collaborator
French Society of Rheumatology (Other)
4,182
1
30.2
138.4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare web FLS model (e_FLS) to conventional FLS in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Osteoporotic fractures such as hip fractures and severe fractures are associated with increased morbidity and mortality and impose a large financial burden on healthcare systems. Patients with osteoporosis-related fractures are at higher risk of subsequent fractures. Other severe fractures (pelvis, vertebrae, humerus) have similar consequences, pelvis. The risk of refracture after fracture depends on the time: it is 5 times higher in the first 2-3 years, and 2 times higher after. This notion of Imminent Fracture Risk is the basis for the development of post-fracture care pathways called "fracture liaison. The implementation of FLS is the most effective way to reduce the risk of secondary fracture. Despite their success, FLS programs are not an integral part of post-fracture care throughout the France. The investigators believe that the barriers to the implementation of such a pathway are multiple and are largely related to the lack of accessibility for patients to FLS, and to the mobilization of important and unsustainable human resources. Some French public hospitals or institutions are currently building some e_FLS models based on an automatic detection of patients with fractures, and a on a cloud-based system where practitioners across the health care sector can communicate and jointly manage osteoporotic patients. The investigators' hypothesis is that this web FLS (e_FLS) is at least as effective as the classical FLS for the secondary fracture prevention.

    The objective of the investigators' study is to compare web FLS model (e_FLS) to conventional FLS in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture (evAB project).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    4182 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multicentric Study of Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study
    Anticipated Study Start Date :
    Jun 6, 2022
    Anticipated Primary Completion Date :
    Jun 6, 2024
    Anticipated Study Completion Date :
    Dec 12, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    e_FLS

    Patients detected by an automated patient detection tool with a web-based platform

    FLS

    Control group / Conventional group : Patients followed in a conventional fracture liaison department

    Outcome Measures

    Primary Outcome Measures

    1. To compare the efficacy of eFLS to conventional FLS to initiate an antiosteoporotic treatment after a recent fracture (<3 months) at one year in patients aged 60 years and more [one year]

      Number of patients receiving an antiosteoporotic treatment at one year

    Secondary Outcome Measures

    1. To compare the number of patients with recent fracture (less of 3 months) in the eFLS and conventional FLSs [one year]

      Number of patients seen in the FLS

    2. To compare the proportion of patients with incident fracture over one year seen in the eFLS and in conventional FLS [one year]

      Incident fracture rate over 1 year

    3. To compare the proportion of patients with deaths over one year in the eFLS and in conventional FLS [one year]

      Mortality rate over 1 year

    4. To compare the proportion of patients with bone densitometry performed over one year in the eFLS and in conventional FLS [one year]

      Bone densitometry at 1 year

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Men and women aged above 60 years, living in France, with fragility fractures in response to low-energy trauma (e.g., a fall from standing height).

    • The patient or his legal representative does not object to the patient's participation in the research Note: Patients in guardianship or curatorship can be included in this protocol

    Exclusion Criteria:
    • Pathological fractures, high trauma fractures and per prosthetic fractures.

    • Non registration with a social security scheme (holder or beneficiary).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cochin Hospital, Rheumatology Department Paris France 75014

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris
    • French Society of Rheumatology

    Investigators

    • Principal Investigator: Karine BRIOT, MD, PhD, APHP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05303350
    Other Study ID Numbers:
    • APHP211339
    • 2022-A00553-40
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022