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INFRA: Feasibility and Effectiveness of a Coordinated Healthcare Circuit Dedicated to Patients With Handicap

Sponsor
Groupe Hospitalier Mutualiste de Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT04991558
Collaborator
(none)
36
Enrollment
1
Location
23.9
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

France currently has more than 10 million disabled people, including 3 millions who could be better treated. In fact, people with disabilities face many obstacles in accessing care and receiving appropriate support (physical access to certain locations, communication...). Difficulties are also encountered by the healthcare staff, leading to often heterogeneous practices in health establishments.

The INFRA health circuit has been set up at the "Groupe Hospitalier Mutualiste de Grenoble" since June 2018 according to the guidelines published by the French High Authority for Health (HAS) on improving professional practices "Reception, support and organization of care in health establishments for people in situation of handicap "of July 2017. The INFRA nurse collects and anticipates the necessary adaptations for the patient's stay, in conjunction with their caregivers (whether family or institutional). They are an interface with other healthcare professionals to adapt care procedures and protocols (body care, feeding methods, pain management, drug management) to the patient's disability. Before hospitalization and until the patient is discharged, the INFRA nurse transmits to the personnel involved all the information necessary for the proper continuation of care. In addition to legal and regulatory obligations, the INFRA nurse ensures the effective accessibility of the establishment's facilities and premises, and helps maintaining patient autonomy.

The INFRA study is an observational study aimed at assessing the feasibility of the INFRA health circuit and evaluating the benefit for the patients and the healthcare staff.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    36 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Prospective, Single-center Observational Study to Assess the Feasibility and Evaluate the Effectiveness of a Coordinated Healthcare Circuit Dedicated to Patients With Mental and Physical Disabilities Undergoing Planned Surgery
    Actual Study Start Date :
    Sep 3, 2020
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients who followed the entirety of INFRA circuit [At discharge, assessed up to 4 weeks]

    Secondary Outcome Measures

    1. Type of pain evaluation scale selected by the INFRA nurse [enrollment]

    2. Number of healthcare adaptations implemented during hospitalization [At discharge, assessed up to 4 weeks]

    3. Satisfaction of patients and caregivers [At discharge, assessed up to 4 weeks]

      Satisfaction survey answered by patients and caregivers

    4. Satisfaction of healthcare staff [At discharge, assessed up to 4 weeks]

      Satisfaction survey answered by healthcare staff

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 13 years old or more

    • Physical or mental disability, according to french law n°2005-102 of February 11th, 2005

    • Requiring an adaptation of the healthcare circuit

    • Indication of a planned surgical procedure

    Exclusion Criteria:

    • Outpatient

    • Emergency surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Mutualiste de Grenoble Grenoble France 38028

    Sponsors and Collaborators

    • Groupe Hospitalier Mutualiste de Grenoble

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Mutualiste de Grenoble
    ClinicalTrials.gov Identifier:
    NCT04991558
    Other Study ID Numbers:
    • 2019/09-ERA-GHMG
    First Posted:
    Aug 5, 2021
    Last Update Posted:
    Mar 16, 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

    Study Results

    No Results Posted as of Mar 16, 2022