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

Disabilities Mental Clinical Trial

— INFRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991558
• Other study ID #: 2019/09-ERA-GHMG
• Status: Completed
• Start date: September 3, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Mutualiste de Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disabilities Mental
• Disabilities Physical

Locations

Country	Name	City	State
France	Groupe Hospitalier Mutualiste de Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Mutualiste de Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who followed the entirety of INFRA circuit		At discharge, assessed up to 4 weeks
Secondary	Type of pain evaluation scale selected by the INFRA nurse		enrollment
Secondary	Number of healthcare adaptations implemented during hospitalization		At discharge, assessed up to 4 weeks
Secondary	Satisfaction of patients and caregivers	Satisfaction survey answered by patients and caregivers	At discharge, assessed up to 4 weeks
Secondary	Satisfaction of healthcare staff	Satisfaction survey answered by healthcare staff	At discharge, assessed up to 4 weeks