This is an opportunity to take part in a research study. Before you decide whether or not to take part, it is important to understand why the research is being done and what it will involve.

Please take time to read the following information carefully. Please feel free to discuss the study with other people before deciding whether you want to take part, and if you have any questions, please contact LOROS directly using the contact details at the end of this post.

What is the purpose of this study?
This study is being carried out by researchers at LOROS Hospice and the University of Leicester. The purpose of this study is to better understand the experiences of patients who have Dialysis Dependant Kidney Disease from ethnically diverse backgrounds and the healthcare professionals taking care of them, in the context of the COVID-19 pandemic. LOROS hope to use the information to develop an understanding of patient experiences and perceptions of End of Life Care Planning to be able to provide better training to healthcare professionals.

Who can take part?
You can take part because you are a bereaved relative or friend of a patient from an ethnically diverse background who had Dialysis Dependant Kidney Disease.

Do I have to take part?
No, it is up to you to decide whether or not to take part. If you do decide to take part you are free to withdraw from the study at any time, without giving a reason. The research team will keep any data that they have already collected up until the point that you decided to withdraw, but they will not collect any further data or information from or about you.

What will my participation involve?
If after reading this information you decide to take part in the study you will be asked to sign a consent form, or if you are not meeting in person you can give consent verbally, which will be audio recorded. You will then be invited to have a one-on-one interview with a researcher.

The interview will be an informal discussion lasting up to 60 minutes and can be arranged at a date and time to suit you. This can take place either face-to-face in your home if you live in the Leicestershire region, at LOROS Hospice or a suitable location of your choice, or remotely via phone or video call (e.g. Zoom). The interview can be in a language other than English if you prefer. We will provide an interpreter to help the researcher if this is needed. The interview may be audio and video recorded and later transcribed.

The interviews will focus on your experience of supporting a relative or friend who had Dialysis Dependant Kidney Disease (DDKD) and the care received from health professionals managing this. Researchers would like to find out about:

• your experience of talking with health care professionals about this DDKD and discussions that you have had about choices and decisions about end-of-life care and treatments for your relative or friend;
• your feelings about how the COVID-19 pandemic impacted these conversations with healthcare professionals;
• what you and your relative or friend found most and least helpful in the support and information health care professionals provided about living with DDKD since the start of the COVID-19 pandemic, and if there are any ways in which this could be improved

What are the possible benefits of taking part?
The study may not help you directly but some people find it helpful to have the chance to share their experiences of illness, treatment and care with someone who is not directly involved. The information collected may help healthcare professionals to better understand the experiences of patients from diverse ethnic backgrounds and their relatives and friends. This should help to improve the care and support provided to families and friends in the future.

You will be given a £20 voucher after the interview as a “Thank You” for your time. If you incur any travel expenses as a result of your participation these may be reimbursed on production of a receipt for public transport or as a claim for mileage which would be reimbursed at LOROS. Reasonable travel expenses will be paid in full.

Interviews with Leicestershire participants can be held in person at your request. All other interviews for participants outside of Leicestershire will be undertaken via Zoom.

What are the possible disadvantages/risks of taking part?
The research team understands that as a bereaved caregiver, discussing your experiences may be difficult and upsetting. Please consider this carefully. Please remember that you will never be under any pressure to answer any questions or talk about any topics that you prefer not to discuss. You can take a break, stop the interview or withdraw from the study at any time by letting the researcher know that this is your wish.

Your confidentiality may be breached if you disclose information that is a safeguarding concern. These would be concerns regarding the safety of children and/or adults (both yourself and/or other adults). In such circumstances, it may be necessary for the research team to share your information with the relevant professionals. They would however try and discuss the issue with yourself first, wherever possible.

Interviews will be conducted by a trained researcher from the study team and will last for up to 60 minutes (though can be stopped by the participant at any time). They will be asking questions about your experiences of End of Life Care Planning (EOLP). There will not be “right” or “wrong” answers, rather, they will be using the questions as a guide to help us structure the interview. Participants can share as much or as little information as they want to and can choose not to answer certain questions if they do not feel comfortable doing so.

The interviewer will use a Dictaphone to record the interview so that we can ensure that participants’ feelings are analysed wholly. The sound recorder will be encrypted (secured) with a password. Recordings will only be shared with a University-appointed professional transcription service, which has a contract (a Confidential Data Agreement) to follow our security and confidentiality policies. All the recordings will be deleted once they are transcribed. The interview transcriptions will be pseudonymous and kept confidential. Any data collected as part of the study may be shared between LOROS and the University of Leicester.

If you experience any distress during the study you will be provided with information about local third-party organisations that you may contact. A list of organisations is available upon request. Alternatively, you may also speak to your GP or professional counsellor.

What will happen to the results of this study?
The results of the study will be used to help health care professionals and services improve the care and support they provide to patients who have DDKD from ethnically diverse backgrounds.

The researchers will use information collected to inform the development of educational resources for health care professionals as well as resources available for ethnically diverse patients and their relatives and friends. The results of the research will be made widely available through talking to the public and professionals, publications and conference presentations. We will write our reports and may use direct quotes from the interviews in a way that you cannot be identified.
If you would like us to, we will send you a summary of the findings and recommendations at the end of the study.

With your permission we may use the pseudonymised data collected in this study to support other ethically approved research in the future. Pseudonymised data is where your name and personal details are removed and replaced with a participant identification number. This may mean that the pseudonymised data may be shared with other researchers.

What data will you collect about me?
The University of Leicester and LOROS will be using information from you in order to undertake this study. The University of Leicester is the Sponsor for this study and will act as the data controller. This means they are responsible for looking after your information and using it properly.
All study data will be stored securely for the duration of the study and may be shared between the University of Leicester and LOROS.

How will we use information about you? 
We will need to use information from you for this research project.
This information will include your;

• Name and initials
• Age
• Ethnicity
• Language of Interview
• Faith/religion
• Migrant history of the deceased
• Highest educational attainment of the deceased
• Age, Sex and Ethnicity of the deceased
• Last occupation of the deceased
• Diagnosis of deceased
• Length of dialysis and other health issues of the deceased
• Personal contact details including address and postcode
• Family structure including people who resided with the deceased
• Information provided in your interview transcript

People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no one can work out that you took part in the study.

What are your choices about how your information is used?

• You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
• Because of the way that your information is transcribed, it will not be possible for interview data to be removed from the study once it has been transcribed, therefore if you change your mind after the interview you may contact us within two weeks of your interview if you wish for your data to be erased and withdrawn from analysis.
• We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
• If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

Where can you find out more about how your information is used?
The audio transcripts collected at the time of your interview will be sent to an approved 3^rd party transcriber. This approved provider also follows General Data Protection Regulation (GDPR) and the Data Protection Act. All activities with your data follow UK laws and rules.

This study involves LOROS and the University of Leicester, therefore data will be transferred between participating organisations in order to support the research which may at times be identifiable. The wider research team may also include people who check the quality of the research. Regulators may also need to check the research. They will compare the recorded research data with your transcripts.
You can find out more about how we use your information

• at www.hra.nhs.uk/information-about-patients/
• by asking one of the research team
• University of Leicester [Study Sponsor] Data Protection Officer dpo@le.ac.uk or LOROS Data Protection officer marlon.adams@loros.co.uk
• by sending an email to research@loros.co.uk or
• by ringing us on 0116 231 8498

Will the information I provide be kept confidential?
Yes, any identifiable data you provide will be kept confidential. Your identifiable data will not be shared outside of the research team consisting of LOROS and the University of Leicester. The interview audio recordings will be sent securely to a qualified 3^rd party professional (transcriber) who will listen to them and turn them into a written document (transcript). Your name and identifying details will be removed from interview transcripts and replaced with a study identification number so that you cannot be recognised.

All interview recordings will be deleted from the recorder after having been transferred to the secure University of Leicester computers. Any direct quotations that we use to illustrate important findings will be pseudonymised before publication so that no one can identify you, your relative/friend or the hospital where care was given.
At the end of the study, your personal information will be disposed of securely. The interview transcript will be kept for six years before also being disposed of securely.

What if something goes wrong?
It is very unlikely that you would be harmed by taking part in this type of research study.
However, if you have concerns about any aspect of this study, you can speak to the researchers in the first instance who will do their best to answer your questions. If you remain unhappy and wish to address your concerns or complaints on a formal basis, you should contact the Patient Information and Liaison Service (PILS) Free phone line:  08081 788337 or alternatively write to: Patient Information and Liaison Service, The Firs, C/O Glenfield Hospital, Groby Road, Leicester, LE3 9QP. Email: pils@uhl-tr.nhs.uk
In the unlikely event that something does go wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for legal action for compensation but you may have to pay your legal costs. The normal NHS complaints mechanisms will still be available to you.

 Who is funding and organising this study?
The research is funded by a grant made to LOROS Hospice and is being organised by the research team at LOROS Hospice and University of Leicester.

Who has approved this study?
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect participants’ interests. This study has been given a favourable opinion by the West Midlands NHS Research Ethics Committee (REC reference 22/EE/0255). This study has received sponsorship from the University of Leicester, who have reviewed the protocol.

What should I do now?
If you would like more information about the study please contact the research team. You can do this by Telephone: 0116 231 8498, or by email: research@loros.co.uk. Our team will be happy to discuss any concerns and to answer your questions. Recruitment for this study closes on December 31 2023.