Participant Information Sheet for All Emergency Department Staff
Intervention 4 WoWe@NZEDs
Formal Study title:
Positive Participatory Organisational Intervention to Reduce Burnout in New Zealand Emergency Department Staff – Multisite Study
Lead Researcher: Dr Mike Nicholls
Study Site: Te Tai Tokerau, Te Toka Tumai Auckland, Hauora a Toi Bay of Plenty, Te Matau a Māui Hawke's Bay, Ōtautahi Christchurch, Ōtepoti Dunedin
Contact phone number: 0212066245
Ethics committee ref.: 2023 EXP 15332
You are invited to take part in a study on burnout and workplace wellbeing in New Zealand emergency departments (EDs). Your participation will involve completion of a survey that takes 5-10 minutes to complete. Whether or not you take part is your choice. If you don’t want to take part, you don’t have to give a reason.
This Participant Information Sheet will help you decide if you’d like to take part. It sets out why we are doing the study, what your participation would involve, what the benefits and risks to you might be, and what would happen after the study ends. You do not have to decide today whether you will participate in this study. Before you decide you may want to talk about the study with other people, such as family, whānau, friends, colleagues, or healthcare providers. Feel free to do this.
If you agree to take part in this study, you will be asked to check an electronic consent tickbox on the last page of this document.
This document is 9 pages long, including the Consent Form. Please make sure you have read and understood all the pages.
Voluntary Participation and Withdrawal From This Study
Your participation is entirely voluntary. You are free to decline to participate without experiencing any disadvantage.
What is the purpose of the study?
This study is about staff burnout and workplace wellbeing in New Zealand EDs. An intervention will be implemented in your ED to try to improve staff burnout and wellbeing, your ED leadership team has agreed to this. This study evaluates that intervention via a survey before and after the intervention has been implemented. This research will increase knowledge about how to improve ED staff burnout and wellbeing. This knowledge will be useful for staff and patients in New Zealand EDs, and in healthcare in general.
How is the study designed?
Eight EDs will be the study sites. All ED staff from these departments will have access to the study intervention regardless of participation in the study surveys. Surveys will be used to assess the effectiveness of the intervention. Surveys will be done before and after the intervention introduction and will take 5-10 minutes to answer. We aim for 900 staff to answer the surveys.
The intervention will have three parts. These parts are aimed at three "levels" at the workplace. The levels are the individual, the group, and the system level.
Individual-level part of the intervention. All staff in the ED can choose to try one, or more, of three individual-level interventions. These interventions are mostly based on positive psychology. These are:
a mindfulness intervention, or
a three good things intervention, or
a looking forward intervention.
These will all be available online. These are expected to take a total of around 100 minutes over 1 month. Staff can participate in one, two, or all three of these interventions.
Group-level part of the intervention. A group, the Local Champions Group (LCG) within each ED will choose the most appropriate group level intervention for their ED from 2 options. These will be either:
a Learning from Excellence intervention, or
a Clinical Event Debriefing intervention.
The LCG will lead the implementation of this. These will be part of the usual practice of the ED. You can choose to participate as much or as little as you wish, as you would with any other departmental practice that is "business as usual."
System-level part of the intervention. The system-level part of the intervention will be set up so that all staff are able to participate and contribute to improving care in their ED. A system, the Quality Improvement Learning System (QILS) will be set up by the LCG. This system will make it simple and easy for all staff to contribute to improving care in the ED. Using QILS, staff will be able to highlight important problems within the department, have those problems recognised, carefully thought about, and worked on by a group. Communication with staff who recognise problems is a big feature of QILS, and staff are encouraged to suggest and work on solutions.
The LCG will lead the implementation of this. This will be part of the usual practice of the ED. You can choose to participate as much or as little as you wish, as you would with any other departmental practice that is "business as usual."
We are asking your permission today to complete a survey before or after the intervention has been available in your ED.
Who can take part in the Survey?
All staff that work in the ED are eligible to participate in the survey.
To be eligible participants must
identify as a member of ED staff, and
work there regularly (at least one shift per fortnight), and
be a current member of staff.
What will my participation in the Survey involve?
All staff in the EDs can participate in none, some, or all parts of the intervention if they wish – it will be made freely available, and no data is being recorded on an individual’s use of the intervention.
All staff in the EDs can participate in the survey. Surveys will be used to research how effective the intervention is. The surveys:
Will be done online.
Will be done before and 12 months after the introduction of the intervention.
Will each take approximately 5-10 minutes to answer.
Will have questions from different questionnaires.
Survey questions will be about
Demographics (work role, ethnicity, age group, which ED you are answering about, how long you have work at the ED, etc.),
Burnout (the Copenhagen Burnout Inventory),
Overall wellbeing (World Health Organisation WHO-5 Wellbeing Index),
Engagement at work (Utrecht Work Engagement Scale (UWES)),
Empowerment at work (Psychological Empowerment in the Workplace).
What are the possible risks of this study?
Although unlikely to occur, potential harms to participants who answer the surveys include distressing thoughts and emotions arising from answering the questions, especially relating to work.
The interventions are safe and have been used ad hoc throughout Te Whatu Ora.
What are the possible benefits of this study?
There are no direct benefits from participating in the surveys. However you will know that the intervention has been fully evaluated and that if it continues it has a direct benefit on staff burnout, wellbeing and engagement.
Indirectly, patients and other healthcare consumers may benefit through improved work processes and overall improved staff wellbeing in the ED.
Will any costs be reimbursed?
There will be no financial costs from taking part in the survey. The survey will take about 15 minutes to complete.
What if something goes wrong?
If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover.
What will happen to my information?
During the survey the study researchers will record information about you and your participation in the survey. You cannot take part in this survey if you do not consent to the collection of this information.
Identifiable Information
No identifiable information will be collected. Identifiable information is any data that could identify you (e.g. your name, date of birth, or address).
De-identified (Coded) Information
To make sure your personal information is kept confidential, information that identifies you will not be included in any report generated by the researcher. Instead, you will be identified by a code.
The following groups may have access to your coded records:
· The Co-ordinating investigator, Dr Mike Nicholls.
· The statistician and the data manager.
· Regulatory agencies (for example, the Health And Disability Ethics Committee).
The results of the study will be published and/or presented, but not in a form that would reasonably be expected to identify you.
Future Research Using Your Information.
Your coded information may be used for future research related to workplace interventions to reduce burnout or improve wellbeing i.e. in meta-analysis combining data from this study with similar studies. Your coded information may also be used for other medical and/or scientific research that is unrelated to the current study. All such future use will be carefully assessed and advised by the Study Investigators including Kaitiaki for Māori data.
This future research may be conducted overseas. You will not be told when future research is undertaken using your information. Your coded information may be shared widely with other researchers. Your coded information may also be added to information from other studies, to form much larger sets of data.
You will not get reports or other information about any research that is done using your coded information.
Your coded information may be used indefinitely for future research. It will be extremely difficult or impossible to access your coded information, or withdraw consent for its use, once your information has been entered into the study database and/or shared for future research.
Security and Storage of Your Information.
Your coded information will be entered directly by you into a secure server (REDCap). Coded study information will be kept by the researcher in secure, cloud-based storage in Aotearoa New Zealand for 10 years. All storage will comply with local and/or international data security guidelines. The linked data in this study will be destroyed after 10 years.
Risks.
Although efforts will be made to protect your privacy, absolute confidentiality of your information cannot be guaranteed. Even with coded and anonymised information, there is no guarantee that you cannot be identified. The risk of people accessing and misusing your information (e.g. making it harder for you to get or keep a job or health insurance) is currently very small, but may increase in the future as people find new ways of tracing information.
Data-linking can produce a detailed picture of individuals. Data-linking increases the risk of identifying individuals and possibly others who may be in the same households, organisations, iwi or hapū. Some of the data sets being linked may have been designed, and some data may have been collected, without the intention of them being used with other data sets. Some data sets may have been collected in ways which have resulted in biases, meaning that there is the potential for inappropriate inferences to be drawn. These things have the potential to cause harm. While we have taken steps to minimise their likelihood, we cannot guarantee they will not occur.
This research includes basic information such as your ethnic group, geographic region, age range, and sex, and role at work. It is possible that this research could one day help people in the same groups as you. However, it is also possible that research findings could be used inappropriately to support negative stereotypes, stigmatize, or discriminate against members of the same groups as you.
Rights to Access Your Information.
You have the right to request access to your information held by the research team. You also have the right to request that any information you disagree with is corrected. However, it will be extremely difficult or impossible to access your coded information, or withdraw consent for its use, once your information has been entered into the study database.
If you have any questions about the collection and use of information about you, you should ask the Local Investigator or Co-ordinating Investigator, Dr Mike Nicholls.
Rights to Withdraw Your Information.
You may withdraw your consent for the collection and use of your information at any time, by stopping the survey.
If you withdraw your consent, your study participation will end, and the study team will stop collecting information from you.
Information collected up until your withdrawal from the study will continue to be used and included in the study. This is to protect the quality of the study.
Data-Linking.
In this study we will be linking your coded study information with other data sets which include information about you. This is called ‘data-linking’. Because it is so important to help determine how effective the intervention has been, data-linking in this study is mandatory.
In this study we will link data from the survey done before the intervention (pre-intervention survey) with data from the survey done after the intervention (post-intervention survey). For those individual participants who answer both pre- and post-intervention surveys, data from each individual participant will be linked by the answers to the two questions:
· "What is the name of your first primary school" and
· "What was the year of your mother's birth."
It is possible that the above two questions may not be enough to be sure that the correct information is linked. As well, if required, data from answers to the following questions will be used for data-linking:
o Gender ("What is your gender?")
o Profession (" What best describes your profession?")
Māori Data Sovereignty
Māori data sovereignty is about protecting information or knowledge that is about (or comes from) Māori people. We recognise the taonga of the data collected for this study. To help protect this taonga:
· We have consulted with members of the Australasian College for Emergency Medicine (ACEM) Manaaki Mana Rōpū about the collection, ownership, and use of study data. Data are taonga gifted by participants and owned by the Study Investigators.
· We allow Māori organisations to access de-identified study data, for uses that may benefit Māori.
· Māori researchers and Māori ED staff have been involved in the study design from the start of this study. They will continue to be involved with ongoing research, including the interpretation and dissemination of results.
· Consideration for any future use of data outside this study will be led by the study Kaitiaki for Māori data. Sovereignty of data will at all times be prioritised over other considerations for use of data.
What happens after the study or if I change my mind?
You can participate in any part of the study intervention regardless of whether you participate in the research (answer the surveys). The group-level and system-level parts of the study intervention may be available to ED staff if the ED chooses to continue to use these. The individual-level part of the intervention will be available to ED staff at no financial cost for at least 36 months.
All questions regarding the research and interventions can be asked of the Local Investigator and/or the Co-ordinating Investigator.
If you wish to withdraw, you can simply not answer any questions or fill out any surveys. If surveys have already been answered it is unlikely that your data can be removed because it may not be possible to accurately identify who provided the information.
Can i find out the results of the study?
EDs will be provided with a plain English summary of study results. This will be provided by the Co-ordinating Investigator and the research team via the Local Investigator. There will be several ways that the results will be communicated. These will include by email, on departmental posters, at departmental teaching sessions and other usual means of communicating within the ED. As well, the study will be published in open access peer reviewed journals.
The final study results will only be available after the completion of the study. The Co-ordinating Investigator will aim to provide these within 1 year of the end of the study.
The study will be registered on a clinical trial registry, Australia New Zealand Clinical Trials Registry: ANZCTR Request number 385090. This may be accessed here: https://www.anzctr.org.au
Who is funding the study?
This study is being funded by Health Research Council (Career Development Award HRC22/048 (Nicholls)) and the A+ Trust. The funding for the study is being used to pay for some of the Co-ordinating Investigator's time, as well as a small amount of money for some of the Local Investigator's time.
Who Has Approved the study?
This study has been approved by an independent group of people called a Health and Disability Ethics Committee (HDEC), who check that studies meet established ethical standards. The Northern B Health and Disability Ethics Committee has approved this study.
Who do I contact for more information or if I have concerns?
If you have any questions, concerns, or complaints about the study at any stage, you can contact:
Dr Mike Nicholls, Emergency Physician, Co-ordinating Investigator
Telephone number: 021 2066 245
Email: mnicholls@adhb.govt.nz
Prof Stuart Dalziel, Emergency Physician, Lead Supervisor
sdalziel@adhb.govt.nz
If you want to talk to someone who isn’t involved with the study, you can contact an independent health and disability advocate on:
Phone: 0800 555 050
Fax: 0800 2 SUPPORT (0800 2787 7678)
Email: advocacy@advocacy.org.nz
Website: https://www.advocacy.org.nz/
For Māori health support please contact:
Elizabeth Kanivatoa|Ngāti Whātua|Ngāti Kahu|Niue
elizabethk@adhb.govt.nz
Kaiārahi Nāhi CNS, MN- 021 326 914 | Māori Health
Māori Health Lead 021 647 087 | Adult Medical Services
Te Papākāinga Ātawhai o Tāmakī | Te Toka Tumai
Elizabeth and her team can assist, including by directing you to or liaising with your local Māori health team or equivalent.
You can also contact the health and disability ethics committee (HDEC) that approved this study on:
Phone: 0800 4 ETHIC
Email: hdecs@health.govt.nz