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

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

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.

Study Overview

• Status: Completed
• Conditions: Disabilities Mental; Disabilities Physical

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38028
    • Groupe hospitalier mutualiste de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with physical or mental disability, planned for surgical procedure and requiring an adaptation of their healthcare circuit

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who followed the entirety of INFRA circuit	At discharge, assessed up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of pain evaluation scale selected by the INFRA nurse		enrollment
Number of healthcare adaptations implemented during hospitalization		At discharge, assessed up to 4 weeks
Satisfaction of patients and caregivers	Satisfaction survey answered by patients and caregivers	At discharge, assessed up to 4 weeks
Satisfaction of healthcare staff	Satisfaction survey answered by healthcare staff	At discharge, assessed up to 4 weeks

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Mutualiste de Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2019/09-ERA-GHMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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