- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04234503
Ethical Activity Profile of Nurse Managers -Testing Ethics Quarter as an Intervention
The aim of this study is:
- to test a new ethics educational intervention for nurse mangers, Ethics Quarter (EQ) and
- to measure the feasibility and the usability of the EQ
The detailed research questions and hypothesis of this study are as follows:
- Is EQ effective in increasing NMs' ethics knowledge?
- Is EQ effective in increasing NMs' influencing ethics issues?
- Is EQ effective in increasing NMs' ethics research implementing?
- Is EQ effective in increasing NMs' ethics problem identifying?
Is EQ effective in increasing NMs' ethics problem solving?
H 1-5: It is hypothesized that participating into EQ promotes NM's ethics knowledge, influencing ethics issues, ethics research implementing, ethics problem identifying and ethics problem solving compared to comparisons.
- What are NM's perceptions of feasibility and usability of the EQ?
The ultimate goal is to strengthen nurse managers' ethical activity profile and create a new, modern way to promote ethical management of nursing.
Study Overview
Detailed Description
A new educational intervention, EQ, for nurse managers has developed. Intervention development has evaluated by using criteria for complex interventions in health care (CReDECI)- guideline (Möhler et al. 2012). EQ intervention is based on distance learning method and it consists of 12 educational packages included in the virtual learning environment www.etiikanvartti.fi.
Effectiveness of EQ intervention will be tested by using an individually randomized controlled trial with baseline-, post- and follow-up-measurements.The intervention group will participate in the educational EQ intervention and the control group will not participate.
Data will be collected via the membership register of the Union of Health and Social Care Professionals in Finland (Tehy) trade union. This union is a national interest group for nurses, nurse managers and advanced consultants/specialists in the social and health-care sector having a Master's degree (nursing science or related) or registered nurses degree.
Based on statistical power analysis, the required sample size for the study will be 87 NMs at both groups, at 80%, 0.05 significance level.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Turku, Finland
- Finland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Working as a nurse manager
- Finnish-speaking
Exclusion Criteria:
- Unwilling to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ethics Quarter
Nurse managers perform 12 educational packages in web-page www.etiikanvartti.fi.
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In the intervention, nurse managers have two educational packages per week, one taking 15 minutes (one quarter).The structure of the whole intervention is made according to the dimensions of ethical activity profile of nurse managers (Laukkanen et al. a2016; Laukkanen et al b2016) consisting of managers:
Intervention includes also orientation and summary, in total 12 educational packages. After every dimension, NMs have to make self-reflection and development plans, in total five times. This provides them the opportunity to link their everyday experience with ethical theory. |
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No Intervention: Standard organisational ethics structures
Nurse managers continue in their standard organisational ethics structures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in nurse managers' ethical activity profile level.
Time Frame: Baseline, week 6 and week 10
|
Ethical activity profile consists of five dimensions: 1) Developing of own ethics knowledge, 2) Influencing ethical issues, 3) Conducting/implementing ethics research, 4) Identifying and 5) Solving ethical problems. Dimensions 1-3 will be measured with Developing, Influencing and implementing ethics -instrument (DIIEI), Dimension 4 will be measured with Ethical Sensitivity Scale Questionnaire (ESSQ) and Dimension 5 will be measured with Nurses' Moral Courage Scale (NMCS) at baseline (before the intervention), week 6 (after the intervention) and week 10. Results of the all three instruments create one primary outcome measure, ethical activity profile level. All the instruments are 5-point Likert-scales (1=totally disagree; 5=totally agree/1= Does not describe me at all; 5= Describes me very well) and the higher scores indicate higher self-assessed ethical activity profile level. |
Baseline, week 6 and week 10
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Changes in nurse managers' ethical activity profile level.
Time Frame: Baseline, week 6 and week 10
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Changes in nurse managers' self-assessed level of the ethical activity profile measured with the Ethical activity-instrument (EAI) at baseline (before the intervention), week 6 (after the intervention) and week 10.
The higher scores indicate higher self-assessed ethical activity profile level.
|
Baseline, week 6 and week 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in nurse managers' knowledge level.
Time Frame: Baseline, week 6 and week 10
|
Changes in knowledge level is measured with the Nursing Management Ethics Knowledge-test (NMEKT) at baseline (before the intervention), week 6 (after the intervention) and week 10.
The higher scores indicate higher level of knowledge.
|
Baseline, week 6 and week 10
|
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Nurse managers' perceptions of the feasibility and usability of EthicsQuarter.
Time Frame: Week 6
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Perceptions of the feasibility is measured with open questions and the usability of the web site is measured with the System Usability Scale (SUS) at week 6.
The higher scores indicate higher usability.
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Week 6
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EQ-i
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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