Pressure UlcerNCT05238870
Prevention of Skin Damage in the Patient in Prone Position: Development of Education Interventions Based on a Training Needs Assessment Study.
An observational study of Pressure Ulcer and Skin Lesion, run by University Ghent at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Skin Lesion, Acute Respiratory Distress Syndrome
- How many people
- 21 participants
- Where
- 2 sitesBelgium
- Study dates
- 8 Jul 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Clinicians from the multidisciplinary team working with or responsible for the critically ill ventilated patient in the prone position.
Who may be able to join
- • 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.
Show all 9Show fewer
- and/or
- Quality assurance managers or hospital managers. and
- Signed informed consent and voluntary participation.
Who cannot join
- Other than the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
UZ Gent
Ghent, Oost-Vlaanderen
Universitair Ziekenhuis Brussel
Jette, 1090
About this study
Official title: Prevention of Skin Damage in the Patient in Prone Position: Development of the "ProneTection" Education and Training Package and Study of Implementation Conditions in an Intensive Care Setting in Belgium and Sweden.
This is study 1 of 3 - of the overall project: The ProneTection Quality Improvement Project.
The three aims of this study, study 1 are:
- to establish the training needs critical care clinicians have regarding prone positioning,
- to investigate the conditions for effective implementation as in an intensive care setting,
- 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
Read the detailed 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
- the results of our recently published gap-analysis study,
- the needs assessment results from the interviews, keeping the optimal conditions (facilitators) in mind for successful implementation, and
- the critical review and evaluation by eleven key opinion leaders from the established international expert panel
- Being tested
- Interviews for the needs analysis. No intervention.
- Keywords
- prone position, pressure ulcer, moisture-associated skin damage, medical device-related skin injury, skin tear, prone ventilation
- Medical subject headings
- Pressure Ulcer, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews for the needs analysis. No intervention.Other
To develop the education and training package, a needs-analysis is necessary. The clinicians' training needs will be established through interviews.
| Study group | Role | What they receive |
|---|---|---|
| Clinicians (interviewees) from Ghent University Hospital, Belgium | Semi-structured interviews with clinicians Receives: Other: Interviews for the needs analysis. No intervention. | |
| Clinicians (interviewees) from Brussels University Hospital, Belgium | Semi-structured interviews with clinicians Receives: Other: Interviews for the needs analysis. No intervention. | |
| Clinicians (interviewees) from Orebro University Hospital, Sweden | Semi-structured interviews with clinicians Receives: Other: Interviews for the needs analysis. No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: Interviews will be conducted within 1-2 months.
Secondary outcomes (1)
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.
Measured: 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start8 Jul 2022
- Primary completion1 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden
- Responsible party
- Sponsor
- Investigators
- Dimitri Beeckman, Prof, dr, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238870
- Sponsor's protocol ID
- ProneTection#1
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34583874
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Skin Damage in the Patient in Prone Position: Development of the "ProneTection" Education and Training Package and Study of Implementation Conditions in an Intensive Care Setting in Belgium and Sweden.
- ClinicalTrials.gov ID
- NCT05238870
- Acronym / sponsor ID
- ProneTection#1
- Keywords
- prone position, pressure ulcer, moisture-associated skin damage, medical device-related skin injury, skin tear, prone ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Örebro University, Sweden
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is study 1 of 3 - of the overall project: The ProneTection Quality Improvement Project.
The three aims of this study, study 1 are:
- to establish the training needs critical care clinicians have regarding prone positioning,
- to investigate the conditions for effective implementation as in an intensive care setting,
- 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
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
- the results of our recently published gap-analysis study,
- the needs assessment results from the interviews, keeping the optimal conditions (facilitators) in mind for successful implementation, and
- the critical review and evaluation by eleven key opinion leaders from the established international expert panel
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinicians (interviewees) from Ghent University Hospital, Belgium | – | Other: Interviews for the needs analysis. No intervention.Semi-structured interviews with clinicians |
| Clinicians (interviewees) from Brussels University Hospital, Belgium | – | Other: Interviews for the needs analysis. No intervention.Semi-structured interviews with clinicians |
| Clinicians (interviewees) from Orebro University Hospital, Sweden | – | Other: Interviews for the needs analysis. No intervention.Semi-structured interviews with clinicians |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinicians from the multidisciplinary team working with or responsible for the critically ill ventilated patient in the prone position.
Key inclusion criteria (9 listed)
- • 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
Key exclusion criteria (1 listed)
- Other than the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Clinicians (interviewees) from Brussels University Hospital, Belgium, Clinicians (interviewees) from Ghent University Hospital, Belgium, Clinicians (interviewees) from Orebro University Hospital, Sweden |
Primary outcome
Opinion and information regarding the training needs critical care clinicians have regarding prone positioned patients, with a specific focus on skin damage prevention.
Time frame: Interviews will be conducted within 1-2 months.
1. Information regarding the training needs critical care clinicians have regarding prone positioning, 2. Opinions regarding the optimal conditions for effective implementation of the educational interventions in an intensive care setting,
1 secondary outcome
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
Time frame: 2-4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 34583874Fourie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Beeckman, Prof, dr principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer and Skin Lesion, run by University Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opinion and information regarding the training needs critical care clinicians have regarding prone positioned patients, with a specific focus on skin damage prevention. (time frame: Interviews will be conducted within 1-2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05238870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.