Prevention of Skin Damage in the Patient in Prone Position: Development of Education Interventions Based on a Training Needs Assessment Study.

NCT ID: NCT05238870

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-08

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Ulcer Skin Lesion Acute Respiratory Distress Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clinicians (interviewees) from Ghent University Hospital, Belgium

Semi-structured interviews with clinicians

Interviews for the needs analysis. No intervention.

Intervention Type OTHER

To develop the education and training package, a needs-analysis is necessary. The clinicians' training needs will be established through interviews.

Clinicians (interviewees) from Brussels University Hospital, Belgium

Semi-structured interviews with clinicians

Interviews for the needs analysis. No intervention.

Intervention Type OTHER

To develop the education and training package, a needs-analysis is necessary. The clinicians' training needs will be established through interviews.

Clinicians (interviewees) from Orebro University Hospital, Sweden

Semi-structured interviews with clinicians

Interviews for the needs analysis. No intervention.

Intervention Type OTHER

To develop the education and training package, a needs-analysis is necessary. The clinicians' training needs will be established through interviews.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Örebro University, Sweden

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dimitri Beeckman, Prof, dr

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Site Status

Universitair Ziekenhuis Brussel

Jette, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34583874 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ProneTection#1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lung Injury Prediction Study
NCT00889772 COMPLETED
Prone Duration in COVID-19 ARDS
NCT06765759 COMPLETED