- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06470984
Ethics Education to Support Nurse Leaders in HealthCare
April 28, 2025 updated by: Jill K. Greenwood-Williamson, OSF Healthcare System
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Peoria, Illinois, United States, 61602
- OSF Healthcare
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- nurses working direct care 100% of their time without any formal leadership responsibilities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acute Care
Nursing leaders will participate voluntarily and will report their leadership role as acute care (hospital settings).
|
Professional development program provided online to small groups of professional nurse leaders via an educational platform over a 6-week period.
|
|
Experimental: Post-Acute Care
Nursing leaders will participate voluntarily and will report their leadership role as post-acute care (ambulatory settings)
|
Professional development program provided online to small groups of professional nurse leaders via an educational platform over a 6-week period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
change from baseline in the ethical competence measure at 6 weeks after initiation.
|
|
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.
|
change from baseline in the ethical safety measure at 6 weeks after initiation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ethical Confidence Assessment
Time Frame: change from baseline in the ethical competence measure at 6 weeks following initiation and at 3 months.
|
Confidence as a nurse leader for ethical decision making is rated on a 1-10 scale.
0=not confident 10= very confident
|
change from baseline in the ethical competence measure at 6 weeks following initiation and at 3 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jill K Greenwood-Williamson, DNP, RN, OSF Healthcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Barkhordari-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.
- Poikkeus 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.
- Poikkeus 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.
- Salmela 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
June 17, 2024
First Submitted That Met QC Criteria
June 17, 2024
First Posted (Actual)
June 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 1, 2025
Last Update Submitted That Met QC Criteria
April 28, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2193504
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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