Exploring critical care nurses’ decision making when employing chemical or physical restraint to manage hyperactive delirium

What is the purpose of this study?

You are invited to take part in this research study. Before you decide you should understand why this research is being undertaken, and what it would involve for you. Please ask if anything is not clear, and talk to others about the study if you wish.

The use of chemical and physical restraint is common in critical care, however, clinical guidance is over a decade old and nurses have expressed concern over variations in practice, and the challenge of objectively quantifying the level of agitation at which restraint becomes appropriate.

This study aims to explore how nurses make decisions when choosing to apply physical and/or chemical restraint when managing a patient displaying psychomotor agitation and delirious behaviour.

Why have I been invited?

You have been invited to take part because you responded to an invitation issued via social media and you meet the inclusion criteria for the study. You will be a registered nurse working in critical care in the United Kingdom.

Do I have to take part?

No, it is entirely up to you to decide whether or not to take part. If you want to take part, you may wish to keep this information sheet in a safe place.

What will happen to me if I take part?

If you do decide to take part, you will be invited to take part in an interview which will last no more than an hour. It will be conducted by myself, a PhD student from the University of Leeds. I will ask you to describe how you would manage patients portrayed in a series of video clips, and then ask some questions regarding your experience of caring for patients with delirium and the use of restraint.

The interview will be at a time and date which is convenient to you. It can be carried out over the telephone. You will need to have access to the internet and YouTube. The URL will be provided at the start of the interview. You will be asked to pause the videos at identified points to allow discussion.

If you think you would like to be interviewed, please contact myself (Angela Teece a.m.teece@leeds.ac.uk) via email, providing your name, occupation, contact number and email.  You will then be contacted to discuss your participation and consent, or, in the event of too many applicants, notified of this via email and thanked for your interest in the study.

Verbal consent will be requested at the beginning of the interview. After giving consent you are still free to withdraw at any time and without giving a reason. You are also able to decline to answer specific questions without giving a reason. Following the completion of the interview, your data in the form of the audio recording can be withdrawn from the study at your request up until it has been analysed (approximately 6-8 weeks after your interview).

The interviews will be digitally recorded.  After the interview, the whole interview will be typed up by the researcher and an external transcription company, approved by the University. We do this to help us remember what people said and to make sure that all comments are available for the research.

What are the possible advantages and disadvantages and risks of taking part?

The information you provide might help improve the way critical care patients with delirium are managed in the future.  Depending on your experiences, you may find talking about your experiences upsetting, if this is the case we will ensure you are provided with sources of support afterwards. These might include staff counselling services offered by the employing Trust, self-referral to your GP, or national support services such as The Samaritans (116 123).

Will my taking part in the study be kept confidential?

Yes, with exceptions. The exception to this would be if you share something with me that discloses that a person is at risk of harm, or has been harmed, in such a way that would be reduced if we were to disclose the information you have provided. In these cases I may be required to act on the information and report to my supervisor, but I would not do this without involving you in this process.

All personal information about you will be handled in confidence. Data will all be in electronic formats and will be stored on University of Leeds encrypted devices. The transcribed audio files will be used only for analysis and no one outside the project will be allowed access to the original recordings. I will keep these files for five years after the end of the study, but after that, they will be destroyed. Any identifying features that might be mentioned during the interview will be removed from the transcript.

I will keep your name and contact details confidential and will not pass this information to the University of Leeds. I will use this information as needed, to contact you about the research study, and to oversee the quality of the study. Certain individuals from the University of Leeds and regulatory organisations may look at your research records to check the accuracy of the research study. The University of Leeds will only receive information without any identifying information. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details.

The research team will keep identifiable information about you from this study for five years.

What if there is a problem?

If you have a concern about any aspect of this study you should contact Angela Teece on 0113 3431199, or by email a.m.teece@leeds.ac.uk

If they are unable to resolve your concerns, or you wish to make a complaint regarding the study, please contact Professor John Baker (principal supervisor) on 0113 3431271 or by email to j.baker@leeds.ac.uk.

What will happen to the results of the research study?

The results will be published as a series of academic papers and conference presentations. When results are written up, all personal details will be removed so that no-one will know who you are. Direct quotes from the interview may be used in publications in peer-reviewed journals and conference presentations, but pseudonyms will be used in place of actual names.

What will happen to the data generated by the study?

The University of Leeds has a policy of encouraging researchers to deposit research data in the University of Leeds Research Data Repository (known as Research Data Leeds). This allows data to be shared, reused and cited beyond the end of a project. Research Data Leeds holds deposited data for a minimum of 10 years. We will deposit fully anonymised interview transcripts to this repository only if you consent to this during the consent process. If you do not give consent, then your data will not be uploaded to the repository.

Who is organising and funding the research?

This study is organised and funded as part of a PhD at the University of Leeds.

The University of Leeds is the sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The University of Leeds will keep identifiable information about you until transcription. Identifying features will be removed from the transcripts and audio files deleted.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information by contacting governance-ethics@leeds.ac.uk.

Who has reviewed the study?

This study has been reviewed and given favourable opinion by University of Leeds School of Healthcare Research Ethics Committee (Ref: HREC 18-003).

Thank you for taking to read this information sheet

Angela Teece Restraint V3 26th June 2019 IRAS ref: 264614