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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05238870
Other study ID # ProneTection#1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 8, 2022
Est. completion date September 1, 2022

Study information

Verified date February 2022
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is study 1 of 3 - of the overall project: The ProneTection Quality Improvement Project. The three aims of this study, study 1 are: 1. to establish the training needs critical care clinicians have regarding prone positioning, 2. to investigate the conditions for effective implementation as in an intensive care setting, 3. to develop an education and training package (The ProneTection package) for an interdisciplinary team of clinicians on skin damage prevention of patients in the prone position


Description:

Conduct a needs assessment by using semi-structured interviews with an interdisciplinary team of clinicians (Ghent University Hospital (UZ Gent), Brussels University Hospital (UZ Brussel) and several institutions in Sweden, mainly Örebro University Hospital). Concurrently, investigate the conditions for effective implementation in a critical care facility using the same interviews and participants (interviewees). Develop the education and training package (the ProneTection package). The ProneTection package will be based on 1. the results of our recently published gap-analysis study, 2. the needs assessment results from the interviews, keeping the optimal conditions (facilitators) in mind for successful implementation, and 3. the critical review and evaluation by eleven key opinion leaders from the established international expert panel


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date September 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 65 Years
Eligibility Inclusion Criteria: - • Clinicians (nurses, allied health professionals and doctors) working in intensive care units (ICU) are eligible to participate. This can include critical care nurses, respiratory therapists, physiotherapists etc. and/or - Nurses studying towards their speciality as critical care nurses. and/or - Wound care specialists or those responsible for advising on skin damage prevention or managing skin damage/ wounds of the patient in the prone position. and/or • Educators / clinical training facilitators within the hospital or teaching at the university. and/or - Quality assurance managers or hospital managers. and - Signed informed consent and voluntary participation. Exclusion Criteria: - Other than the inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interviews for the needs analysis. No intervention.
To develop the education and training package, a needs-analysis is necessary. The clinicians' training needs will be established through interviews.

Locations

Country Name City State
Belgium UZ Gent Gent Oost-Vlaanderen
Belgium Universitair Ziekenhuis Brussel Jette

Sponsors (2)

Lead Sponsor Collaborator
University Ghent Örebro University, Sweden

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Fourie A, Ahtiala M, Black J, Hevia H, Coyer F, Gefen A, LeBlanc K, Smet S, Vollman K, Walsh Y, Beeckman D. Skin damage prevention in the prone ventilated critically ill patient: A comprehensive review and gap analysis (PRONEtect study). J Tissue Viability. 2021 Nov;30(4):466-477. doi: 10.1016/j.jtv.2021.09.005. Epub 2021 Sep 23. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Opinion and information regarding the training needs critical care clinicians have regarding prone positioned patients, with a specific focus on skin damage prevention. Information regarding the training needs critical care clinicians have regarding prone positioning,
Opinions regarding the optimal conditions for effective implementation of the educational interventions in an intensive care setting,
Interviews will be conducted within 1-2 months.
Secondary The development of an education and training package (The ProneTection package) for an interdisciplinary team of clinicians on skin damage prevention of patients in the prone position Development of online educational materials based on evidence, training needs assessments and expert opinions. 2-4 months
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