EthicsNCT04234503
Ethical Activity Profile of Nurse Managers -Testing Ethics Quarter as an Intervention
A study testing Ethics Quarter in people with Ethics, run by Turku University Hospital at 1 site in Finland.
Trial summary
The aim of this study is: 1. to test a new ethics educational intervention for nurse mangers, Ethics Quarter (EQ) and 2. to measure the feasibility and the usability of the EQ The detailed research questions and hypothesis of this study are as follows: 1. Is EQ effective in increasing NMs' ethics knowledge? 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ethics
- What is being tested?
- Ethics Quarter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteFinland
- Study dates
- 2 Mar 2020to 7 Dec 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Working as a nurse manager
- Finnish-speaking
Who cannot join
- Unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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.
Read the 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.
- Conditions
- Ethics
- Being tested
- Ethics Quarter
- Keywords
- nurse managers, ethical activity profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethics QuarterBehavioural
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:
- Developing of own ethics knowledge,
- Influencing ethical issues,
- Conducting/implementing ethics research,
- Identifying and
- Solving ethical problems.
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.
| Study group | Role | What they receive |
|---|---|---|
| Ethics Quarter | Experimental | Nurse managers perform 12 educational packages in web-page www.etiikanvartti.fi. Receives: Behavioral: Ethics Quarter |
| Standard organisational ethics structures | No intervention | Nurse managers continue in their standard organisational ethics structures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nurse managers' ethical activity profile level.
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.
Measured: Baseline, week 6 and week 10
Changes in nurse managers' ethical activity profile level.
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.
Measured: Baseline, week 6 and week 10
Secondary outcomes (2)
Changes in nurse managers' knowledge level.
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.
Measured: Baseline, week 6 and week 10
Nurse managers' perceptions of the feasibility and usability of EthicsQuarter.
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.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start2 Mar 2020
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
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 EthicsStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Laura Laukkanen, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234503
- Sponsor's protocol ID
- EQ-i
- Status last verified
- Dec 2020
- First submitted
- 13 Jan 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laukkanen L, Suhonen R, Poikkeus T, Loyttyniemi E, Leino-Kilpi H. The effectiveness of the Ethics Quarter intervention on the ethical activity profile of nurse managers: A randomized controlled trial. J Nurs Manag. 2022 Oct;30(7):2126-2137. doi: 10.1111/jonm.13411. Epub 2021 Jul 21.
PubMed 34231275
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethical Activity Profile of Nurse Managers -Testing Ethics Quarter as an Intervention
- ClinicalTrials.gov ID
- NCT04234503
- Acronym / sponsor ID
- EQ-i
- Conditions
- Ethics
- Keywords
- nurse managers, ethical activity profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 21 Jan 2020 (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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethics Quarter | Experimental | Behavioral: Ethics QuarterNurse managers perform 12 educational packages in web-page www.etiikanvartti.fi. |
| Standard organisational ethics structures | No intervention | –Nurse managers continue in their standard organisational ethics structures |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Working as a nurse manager
- Finnish-speaking
Key exclusion criteria (1 listed)
- Unwilling to provide consent
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 |
|---|---|---|
| Ethics QuarterIn 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: 1. Developing of own ethics knowledge, 2. Influencing ethical issues, 3. Conducting/implementing ethics research, 4. Identifying and 5. Solving ethical problems. 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. | Behavioural | Ethics Quarter |
Primary outcome
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.
Changes in nurse managers' ethical activity profile level.
Time frame: Baseline, week 6 and week 10
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.
2 secondary outcomes
Changes in nurse managers' knowledge level.
Time frame: Baseline, week 6 and week 10
Nurse managers' perceptions of the feasibility and usability of EthicsQuarter.
Time frame: Week 6
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 16 Dec 2020.
- Derived from this study: PubMed 34231275Laukkanen L, Suhonen R, Poikkeus T, Loyttyniemi E, Leino-Kilpi H. The effectiveness of the Ethics Quarter intervention on the ethical activity profile of nurse managers: A randomized controlled trial. J Nurs Manag. 2022 Oct;30(7):2126-2137. doi: 10.1111/jonm.13411. Epub 2021 Jul 21.
- Ethical activity profile of nurse managers.Link provided by the sponsor.
- Solving work-related ethical problems.Link provided by the sponsor.
- Proposed criteria for reporting the development and evaluation of complex interventions in healthcare (CReDECI): guideline development.Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethics Quarter in people with Ethics, run by Turku University Hospital at 1 site in Finland.
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: finished, as of the sponsor's last update on 16 Dec 2020. 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 Finland. 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?
Changes in nurse managers' ethical activity profile level. (time frame: Baseline, week 6 and week 10). 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 NCT04234503, 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 16 Dec 2020.