ICUNCT06425692
Work Package 3 Education for ICU Clinicians in Basic Palliative Care
A study testing Education in people with ICU and Staff Attitude, run by Heinrich-Heine University, Duesseldorf.
Trial summary
The EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU, Staff Attitude, Learning
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years
- ICU staff and participants of the EPIC intervention study (physician, nurse)
- participants of patients and family workshops
- agreement to participate in the study
Who cannot join
- \<18 years
- rejection of study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Enhancing Palliative Care in ICU (EPIC) - Work Package 3
The EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. The project is the first European intervention study on palliative care in the ICU using a systems- based approach with proactive patient identification, checklist and blended learning designed to meet the specific needs of ICU staff.
EPIC's vision is to contribute to a change in awareness from a narrow focus on prolonging life to a more holistic approach to care.
Read more
The development of blended learning for intensive care staff is the task of Work Package (WP) 3. The aim is to improve the attitude, understanding and self-confidence of ICU staff. Blended learning is to be developed and implemented for this purpose. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level.
Due to the international character of the project, it is to be developed in English with subtitles in the local languages. In addition a workshop with patient and family advisors will be conducted.
Read the detailed description
Background Around 10% of all deceased people in the population die after being admitted to an intensive care unit (ICU). These patients may have distressing symptoms and may receive more intensive life-prolonging treatment than they would have chosen themselves. This can lead to family stress, but also to mental distress among intensive care staff.
The EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. The project is the first European intervention study on palliative care in the ICU using a systems-based approach with proactive patient identification, checklist and blended learning designed to meet the specific needs of ICU staff. EPIC's vision is to contribute to a change in awareness from a narrow focus on prolonging life to a more holistic approach of care.
Objectives of Work Package (WP) 3 The aim is to improve the attitude, understanding and self-confidence of ICU-staff. Blended learning will be developed and implemented for this purpose. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. Due to the international character of the project, it is to be developed in English with subtitles in the local languages. In addition a workshop with patient and family advisors should conducted.
Development and implementation of blended learning
The blended learning program is to be completed by all ICU staff participating in the study during the crossover period of 4 weeks prior to the intervention. The curriculum will be developed in close collaboration with another work package. The main aim is to teach the standardized EPIC procedures using the following questions:
- Why is palliative care necessary?
- When to call for a specialist palliative care consultation?
- How to message palliative care?
- What are the critical elements of palliative care in the ICU?
Participants first complete the eLearning programme. This is made available to them via the data-secured open-source platform: BeST, Charite. Participants will then take part in interactive online workshops moderated by the investigators involved in the study. The workshop curriculum also focuses on communication skills training and open questions after the eLearning. Two workshops of 90 minutes each will be offered to allow all ICU staff to participate. In addition, a pocket card for symptom assessment, communication and care planning will be developed and handed out at each workshop.
Evaluation of the impact of the training The evaluation of blended learning takes place at different times. On one hand, the validated CPD Response Questionnaire, a 12-item questionnaire to assess the impact of CPD activities on changes in clinical behavioral intentions, will be used. CPD activities can be used as a way of indicating that new knowledge can lead to changes in practice.
Which changes the investigators want to measure will become apparent during the development of the curriculum.
The comparative self-assessment (CSA) gain is used to evaluate the specific learning effects in relation to the increase in knowledge, attitudes and skills. Here, the participants assess their own increase in knowledge in the post/this assessment. The information is assessed using German school grades (1 = very good, 6 = unsatisfactory). Subsequently, the learning gain on the levels of attitude and knowledge can be calculated as CSA Gain [%] = ((MWpre-MWpost)/(Mwpre-1)) x 100.
The learning objectives will be based on the curriculum to be developed, so the questionnaire will also be submitted as an amendment. Both questionnaires will be made available to participants via a link and/or QR code using SoSci Survey tool. The CPD is to be surveyed before and after blended learning and after six months, and the CSA gain after blended learning and also after six months.
The questionnaires are available in English and will be translated back and forth according to the state of the art. Reminders for the follow-up questionnaires will be sent to the participants by e-mail. Results will be communicated to the investigators at other sites and used to update the curriculum after the intervention study has ended.
Conducting and evaluation of the patients and family workshop A co-workshop will be held with patients and relatives to integrate their perspectives and needs in terms of skills and knowledge of professional caregivers. This will then also be evaluated, whereby the content to be developed will provide the items of the evaluation. The evaluation is also collected as an online questionnaire via SoSci.
- Conditions
- ICU, Staff Attitude, Learning, Palliative Care, Patient Care
- Being tested
- Education
- Keywords
- multi-center study, ICU staff, EU-Horizon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Education on basic palliative care via e-learning + webinar to deepen knowledge.
| Study group | Role | What they receive |
|---|---|---|
| Education on basic palliative care | Other | Blended learning for ICU staff and online webinars. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSA-gain
The comparative self-assessment (CSA) gain is used to evaluate the specific learning effects in relation to the increase in knowledge, attitudes and skills [2]. Here, the participants assess their own increase in knowledge in the post/this assessment. The information is assessed using german school grades (1 = very good, 6 = unsatisfactory). Subsequently, the learning gain on the levels of attitude and knowledge can be calculated as "Comparative Self-Assessment Gain" (CSA Gain [%] = ((MWpre- MWpost)/(Mwpre-1)) x 100) using specific outcome evaluation.
Measured: e-Learning: 45 minutes, CSA-gain immediately after e-learning and 6 months post e-learning.
CPD Response Questionnaire ("Continuing professional development")
12-item questionnaire to assess the impact of CPD activities on changes in clinical behavioural intentions
Measured: Right before starting the 45-minute e-learning session + immediately after the completion of one of the offered online workshops (to be held on two Thursdays per month for 5 years) + 6 months post blended learning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ICUStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425692
- Sponsor's protocol ID
- 2023-2676
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raupach T, Munscher C, Beissbarth T, Burckhardt G, Pukrop T. Towards outcome-based programme evaluation: using student comparative self-assessments to determine teaching effectiveness. Med Teach. 2011;33(8):e446-53. doi: 10.3109/0142159X.2011.586751.
PubMed 21774642Legare F, Freitas A, Turcotte S, Borduas F, Jacques A, Luconi F, Godin G, Boucher A, Sargeant J, Labrecque M. Responsiveness of a simple tool for assessing change in behavioral intention after continuing professional development activities. PLoS One. 2017 May 1;12(5):e0176678. doi: 10.1371/journal.pone.0176678. eCollection 2017.
PubMed 28459836
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Palliative Care in ICU (EPIC) - Work Package 3
- ClinicalTrials.gov ID
- NCT06425692
- Acronym / sponsor ID
- 2023-2676
- Conditions
- ICU, Staff Attitude, Learning, Palliative Care, Patient Care
- Keywords
- multi-center study, ICU staff, EU-Horizon
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 22 May 2024 (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.
The EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. The project is the first European intervention study on palliative care in the ICU using a systems- based approach with proactive patient identification, checklist and blended learning designed to meet the specific needs of ICU staff.
EPIC's vision is to contribute to a change in awareness from a narrow focus on prolonging life to a more holistic approach to care.
The development of blended learning for intensive care staff is the task of Work Package (WP) 3. The aim is to improve the attitude, understanding and self-confidence of ICU staff. Blended learning is to be developed and implemented for this purpose. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level.
Due to the international character of the project, it is to be developed in English with subtitles in the local languages. In addition a workshop with patient and family advisors will be conducted.
Detailed description
Background Around 10% of all deceased people in the population die after being admitted to an intensive care unit (ICU). These patients may have distressing symptoms and may receive more intensive life-prolonging treatment than they would have chosen themselves. This can lead to family stress, but also to mental distress among intensive care staff.
The EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. The project is the first European intervention study on palliative care in the ICU using a systems-based approach with proactive patient identification, checklist and blended learning designed to meet the specific needs of ICU staff. EPIC's vision is to contribute to a change in awareness from a narrow focus on prolonging life to a more holistic approach of care.
Objectives of Work Package (WP) 3 The aim is to improve the attitude, understanding and self-confidence of ICU-staff. Blended learning will be developed and implemented for this purpose. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. Due to the international character of the project, it is to be developed in English with subtitles in the local languages. In addition a workshop with patient and family advisors should conducted.
Development and implementation of blended learning
The blended learning program is to be completed by all ICU staff participating in the study during the crossover period of 4 weeks prior to the intervention. The curriculum will be developed in close collaboration with another work package. The main aim is to teach the standardized EPIC procedures using the following questions:
- Why is palliative care necessary?
- When to call for a specialist palliative care consultation?
- How to message palliative care?
- What are the critical elements of palliative care in the ICU?
Participants first complete the eLearning programme. This is made available to them via the data-secured open-source platform: BeST, Charite. Participants will then take part in interactive online workshops moderated by the investigators involved in the study. The workshop curriculum also focuses on communication skills training and open questions after the eLearning. Two workshops of 90 minutes each will be offered to allow all ICU staff to participate. In addition, a pocket card for symptom assessment, communication and care planning will be developed and handed out at each workshop.
Evaluation of the impact of the training The evaluation of blended learning takes place at different times. On one hand, the validated CPD Response Questionnaire, a 12-item questionnaire to assess the impact of CPD activities on changes in clinical behavioral intentions, will be used. CPD activities can be used as a way of indicating that new knowledge can lead to changes in practice.
Which changes the investigators want to measure will become apparent during the development of the curriculum.
The comparative self-assessment (CSA) gain is used to evaluate the specific learning effects in relation to the increase in knowledge, attitudes and skills. Here, the participants assess their own increase in knowledge in the post/this assessment. The information is assessed using German school grades (1 = very good, 6 = unsatisfactory). Subsequently, the learning gain on the levels of attitude and knowledge can be calculated as CSA Gain [%] = ((MWpre-MWpost)/(Mwpre-1)) x 100.
The learning objectives will be based on the curriculum to be developed, so the questionnaire will also be submitted as an amendment. Both questionnaires will be made available to participants via a link and/or QR code using SoSci Survey tool. The CPD is to be surveyed before and after blended learning and after six months, and the CSA gain after blended learning and also after six months.
The questionnaires are available in English and will be translated back and forth according to the state of the art. Reminders for the follow-up questionnaires will be sent to the participants by e-mail. Results will be communicated to the investigators at other sites and used to update the curriculum after the intervention study has ended.
Conducting and evaluation of the patients and family workshop A co-workshop will be held with patients and relatives to integrate their perspectives and needs in terms of skills and knowledge of professional caregivers. This will then also be evaluated, whereby the content to be developed will provide the items of the evaluation. The evaluation is also collected as an online questionnaire via SoSci.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education on basic palliative care | Other | Behavioral: EducationBlended learning for ICU staff and online webinars. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years
- ICU staff and participants of the EPIC intervention study (physician, nurse)
- participants of patients and family workshops
- agreement to participate in the study
Key exclusion criteria (2 listed)
- \<18 years
- rejection of study participation.
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 |
|---|---|---|
| EducationEducation on basic palliative care via e-learning + webinar to deepen knowledge. | Behavioural | Education on basic palliative care |
Primary outcome
CSA-gain
Time frame: e-Learning: 45 minutes, CSA-gain immediately after e-learning and 6 months post e-learning.
The comparative self-assessment (CSA) gain is used to evaluate the specific learning effects in relation to the increase in knowledge, attitudes and skills [2]. Here, the participants assess their own increase in knowledge in the post/this assessment. The information is assessed using german school grades (1 = very good, 6 = unsatisfactory). Subsequently, the learning gain on the levels of attitude and knowledge can be calculated as "Comparative Self-Assessment Gain" (CSA Gain [%] = ((MWpre- MWpost)/(Mwpre-1)) x 100) using specific outcome evaluation.
CPD Response Questionnaire ("Continuing professional development")
Time frame: Right before starting the 45-minute e-learning session + immediately after the completion of one of the offered online workshops (to be held on two Thursdays per month for 5 years) + 6 months post blended learning.
12-item questionnaire to assess the impact of CPD activities on changes in clinical behavioural intentions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 21774642Raupach T, Munscher C, Beissbarth T, Burckhardt G, Pukrop T. Towards outcome-based programme evaluation: using student comparative self-assessments to determine teaching effectiveness. Med Teach. 2011;33(8):e446-53. doi: 10.3109/0142159X.2011.586751.
- Background: PubMed 28459836Legare F, Freitas A, Turcotte S, Borduas F, Jacques A, Luconi F, Godin G, Boucher A, Sargeant J, Labrecque M. Responsiveness of a simple tool for assessing change in behavioral intention after continuing professional development activities. PLoS One. 2017 May 1;12(5):e0176678. doi: 10.1371/journal.pone.0176678. eCollection 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with ICU and Staff Attitude, run by Heinrich-Heine University, Duesseldorf.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Neukirchen, MD (GER 0049-211-08700, martin.neukirchen@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSA-gain (time frame: e-Learning: 45 minutes, CSA-gain immediately after e-learning and 6 months post e-learning.). The study lists 2 primary outcomes in all. 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 NCT06425692, which also lists 2 linked publications.
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 22 May 2024.