Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord (QUALIPREPS)

Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord: Building a Conceptual Framework Based on the Perceptions and Behaviors of Patients and Professionals Involved

The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network of SCI patients whose general organization refers to the medical literature and the recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work (CFW) will be set up and semi-structured interviews will be conducted with patients and professionals. They will confirm or dismiss the CFW gradually with a refined coding As of domains and sub-domains of the skin preventing spinal cord injury related to the perceptions and behaviors of those involved in the sector. Quality control will be provided by experts in qualitative research and interviews will be stopped when the analyzes will further refine the domains and subdomains. A final framework will be validated to modulate our organization.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Pressure Ulcers
• Intervention / Treatment: Other: qualitative interviews

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

Contacts and Locations

Study Locations

• France
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consists of SCI patients recruited in the Physical Medicine and Nantes University Hospital Rehabilitation 15 to 30 patients will be included. Meanwhile, from 10 to 15 professionals involved in the care sector with SCI Nantes University Hospital (mainly caregivers and administrative staff)

Description

Inclusion Criteria:

• - Paying patients:
• Spinal cord injured person from any level of injury and any post-traumatic period
• Age 18 to 65 years inclusive
• Person affiliated to the social security or receiving such a plan
• Main ambulation mode: Wheelchair

• Agreeing to participate in interviews

  -- Professional side:

• Medical and paramedical health professionals involved in the care sector or studied various professionals (administrators, insurers, ...) involved in the studied care sector
• Agreeing to participate in interviews

Exclusion Criteria:

• Minors or patients older than 65 years
• Person unable to consent
• Who do not speak the French language
• Person refusing to attend meetings
• Hospitalized person without consent
• Cognitive pathologies incompatible with interviews
• Main wandering mode of patients: walking
• Protected adults

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients; SCI recruited Physical Medicine and Nantes University Hospital Rehabilitation. Recruitment will try to balance the number of people in four sub-groups followed and complicated (= history of pelvic pressure sores), not followed and uncomplicated, monitored and uncomplicated, not followed and complicated	Other: qualitative interviews; semi-structured interviews as a conceptual frame work
health professionals; those involved in the chain of care Spinal Cord concerning various professions (including medical, paramedical and administrative) decision and variable influence on the organization of the die care of spinal injuries.	Other: qualitative interviews; semi-structured interviews as a conceptual frame work

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of a comprehensive conceptual framework reflecting the perceptions and behaviors of patients and professionals involved in the organization of care	specific conceptual framework of preventive organization of the eschar with SCI from domains and subdomains reflecting the perceptions and behaviors of patients and professionals applicable to organizational changes in the medical care of spinal cord injury .	Baseline

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Marc LE FORT, Dr, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): September 1, 2022
• Study Completion (ACTUAL): September 1, 2022

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (ESTIMATE): September 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: prevention; pressure ulcers; organization
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Wounds and Injuries; Skin Ulcer; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Pressure Ulcer
• Other Study ID Numbers: RC15_0023