Knowledge, Attitudes, PracticeNCT06470984
Ethics Education to Support Nurse Leaders in HealthCare
A study testing Educational intervention in people with Knowledge, Attitudes, Practice, run by OSF Healthcare System at 1 site in United States.
Trial summary
Using an exploratory study design with an educational intervention, a pre/post evaluation of ethical confidence and competence will be completed for nursing leaders working in either acute care or post-acute care with primary purpose to increase ethical competency and confidence in decision making for nursing leaders… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2024to 31 Dec 2025
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- employment within an in-patient or outpatient non-profit healthcare setting as a nursing leader.
- settings include acute-care units and post-acute care facilities
Who cannot join
- nurses working direct care 100% of their time without any formal leadership responsibilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ethics Education Supporting Acute and Post-Acute Nurse Leaders - 2nd Cohort
Using an exploratory study design with an educational intervention, a pre/post evaluation of ethical confidence and competence will be completed for nursing leaders working in either acute care or post-acute care with primary purpose to increase ethical competency and confidence in decision making for nursing leaders in a clinical role.
Read the detailed description
The purpose of this project is to implement an ethics educational program that has been developed in collaboration with subject matter experts to support patient facing nursing leaders. The intervention is an ethics education pathway, which will be used for approximately 60-80 patient-facing nurse leaders who practice in either acute care or post-acute care over a 6-week period. One Pre and two post-assessment questionnaires will be distributed, which include the "Ethical Competence Support Questionnaire" © and the "Ethical Safety Questionnaire" ©. Permission for the instrument use was obtained from the author.
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- Educational intervention
- Keywords
- nursing ethics, clinical ethics, ethical competence
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
Professional development program provided online to small groups of professional nurse leaders via an educational platform over a 6-week period.
| Study group | Role | What they receive |
|---|---|---|
| Acute Care | Experimental | Nursing leaders will participate voluntarily and will report their leadership role as acute care (hospital settings). Receives: Behavioral: Educational intervention |
| Post-Acute Care | Experimental | Nursing leaders will participate voluntarily and will report their leadership role as post-acute care (ambulatory settings) Receives: Behavioral: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ethical Competence Support Questionnaire
The ethical competence support questionnaire contains 27 items addressing four subcategories: encouragement of ethical activity, provision of information on ethical issues, dealing with ethical issues, and conversational support. A 5-point Likert Scale is used for measurement: Strong disagree to Strongly Agree. Minimum value = 1 maximum value =5.
Measured: change from baseline in the ethical competence measure at 6 weeks after initiation.
Ethical Safety Questionnaire
The ethical safety questionnaire contains11 items addressing four subcategories: general ethical safety, ethical autonomy, ethical respect, and ethical competence. A 5-point Likert Scale is used for measurement: Strong disagree to Strongly Agree. Minimum value = 1 maximum value =5.
Measured: change from baseline in the ethical safety measure at 6 weeks after initiation.
Secondary outcomes (1)
Ethical Confidence Assessment
Confidence as a nurse leader for ethical decision making is rated on a 1-10 scale. 0=not confident 10= very confident
Measured: change from baseline in the ethical competence measure at 6 weeks following initiation and at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start2 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill K. Greenwood-Williamson, OSF Healthcare System
- Investigators
- Jill K Greenwood-Williamson, DNP, RN, Principal investigator, OSF HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470984
- Sponsor's protocol ID
- 2193504
- Status last verified
- Apr 2025
- First submitted
- 17 Jun 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aitamaa E, Suhonen R, Iltanen S, Puukka P, Leino-Kilpi H. Ethical problems in nursing management: Frequency and difficulty of the problems. Health Care Manage Rev. 2021 Jan/Mar;46(1):25-34. doi: 10.1097/HMR.0000000000000236.
PubMed 30724758Barkhordari-Sharifabad M, Ashktorab T, Atashzadeh-Shoorideh F. Obstacles and problems of ethical leadership from the perspective of nursing leaders: a qualitative content analysis. J Med Ethics Hist Med. 2017 Feb 21;10:1. eCollection 2017.
PubMed 28523116Poikkeus T, Suhonen R, Katajisto J, Leino-Kilpi H. Organisational and individual support for nurses' ethical competence: A cross-sectional survey. Nurs Ethics. 2018 May;25(3):376-392. doi: 10.1177/0969733016642627. Epub 2016 May 10.
PubMed 27165144Poikkeus T, Suhonen R, Katajisto J, Leino-Kilpi H. Relationships between organizational and individual support, nurses' ethical competence, ethical safety, and work satisfaction. Health Care Manage Rev. 2020 Jan/Mar;45(1):83-93. doi: 10.1097/HMR.0000000000000195.
PubMed 29533273Salmela S, Koskinen C, Eriksson K. Nurse leaders as managers of ethically sustainable caring cultures. J Adv Nurs. 2017 Apr;73(4):871-882. doi: 10.1111/jan.13184. Epub 2016 Nov 11.
PubMed 27732746
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethics Education Supporting Acute and Post-Acute Nurse Leaders - 2nd Cohort
- ClinicalTrials.gov ID
- NCT06470984
- Acronym / sponsor ID
- 2193504
- Conditions
- Knowledge, Attitudes, Practice
- Keywords
- nursing ethics, clinical ethics, ethical competence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jun 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.
Using an exploratory study design with an educational intervention, a pre/post evaluation of ethical confidence and competence will be completed for nursing leaders working in either acute care or post-acute care with primary purpose to increase ethical competency and confidence in decision making for nursing leaders in a clinical role.
Detailed description
The purpose of this project is to implement an ethics educational program that has been developed in collaboration with subject matter experts to support patient facing nursing leaders. The intervention is an ethics education pathway, which will be used for approximately 60-80 patient-facing nurse leaders who practice in either acute care or post-acute care over a 6-week period. One Pre and two post-assessment questionnaires will be distributed, which include the "Ethical Competence Support Questionnaire" © and the "Ethical Safety Questionnaire" ©. Permission for the instrument use was obtained from the author.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Care | Experimental | Behavioral: Educational interventionNursing leaders will participate voluntarily and will report their leadership role as acute care (hospital settings). |
| Post-Acute Care | Experimental | Behavioral: Educational interventionNursing leaders will participate voluntarily and will report their leadership role as post-acute care (ambulatory settings) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- employment within an in-patient or outpatient non-profit healthcare setting as a nursing leader.
- settings include acute-care units and post-acute care facilities
Key exclusion criteria (1 listed)
- nurses working direct care 100% of their time without any formal leadership responsibilities
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 |
|---|---|---|
| Educational interventionProfessional development program provided online to small groups of professional nurse leaders via an educational platform over a 6-week period. | Behavioural | Acute Care, Post-Acute Care |
Primary outcome
Ethical Competence Support Questionnaire
Time frame: change from baseline in the ethical competence measure at 6 weeks after initiation.
The ethical competence support questionnaire contains 27 items addressing four subcategories: encouragement of ethical activity, provision of information on ethical issues, dealing with ethical issues, and conversational support. A 5-point Likert Scale is used for measurement: Strong disagree to Strongly Agree. Minimum value = 1 maximum value =5.
Ethical Safety Questionnaire
Time frame: change from baseline in the ethical safety measure at 6 weeks after initiation.
The ethical safety questionnaire contains11 items addressing four subcategories: general ethical safety, ethical autonomy, ethical respect, and ethical competence. A 5-point Likert Scale is used for measurement: Strong disagree to Strongly Agree. Minimum value = 1 maximum value =5.
1 secondary outcome
Ethical Confidence Assessment
Time frame: change from baseline in the ethical competence measure at 6 weeks following initiation and at 3 months.
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 1 May 2025.
- Background: PubMed 30724758Aitamaa E, Suhonen R, Iltanen S, Puukka P, Leino-Kilpi H. Ethical problems in nursing management: Frequency and difficulty of the problems. Health Care Manage Rev. 2021 Jan/Mar;46(1):25-34. doi: 10.1097/HMR.0000000000000236.
- Background: PubMed 28523116Barkhordari-Sharifabad M, Ashktorab T, Atashzadeh-Shoorideh F. Obstacles and problems of ethical leadership from the perspective of nursing leaders: a qualitative content analysis. J Med Ethics Hist Med. 2017 Feb 21;10:1. eCollection 2017.
- Background: PubMed 27165144Poikkeus T, Suhonen R, Katajisto J, Leino-Kilpi H. Organisational and individual support for nurses' ethical competence: A cross-sectional survey. Nurs Ethics. 2018 May;25(3):376-392. doi: 10.1177/0969733016642627. Epub 2016 May 10.
- Background: PubMed 29533273Poikkeus T, Suhonen R, Katajisto J, Leino-Kilpi H. Relationships between organizational and individual support, nurses' ethical competence, ethical safety, and work satisfaction. Health Care Manage Rev. 2020 Jan/Mar;45(1):83-93. doi: 10.1097/HMR.0000000000000195.
- Background: PubMed 27732746Salmela S, Koskinen C, Eriksson K. Nurse leaders as managers of ethically sustainable caring cultures. J Adv Nurs. 2017 Apr;73(4):871-882. doi: 10.1111/jan.13184. Epub 2016 Nov 11.
- 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.
Jill K Greenwood-Williamson, DNP, RN principal investigator
OSF HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Knowledge, Attitudes, Practice, run by OSF Healthcare System at 1 site in United States.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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?
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?
Ethical Competence Support Questionnaire (time frame: change from baseline in the ethical competence measure at 6 weeks after initiation.). 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 NCT06470984, which also lists 5 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 1 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.