#WardSonar: a real-time measure of safety for mental health wards

We would like to invite you to take part in our research study. Before you decide we would like you to understand why the research is being done and what it would involve for you. Ask us if anything is not clear and talk to others about the study if you wish.

What is the purpose of the study?

Sometimes service users can feel unsafe on acute mental health wards. This project will develop and test a system to collect information from service users about how safe they are feeling on mental health wards in real-time, and make this information available to ward staff to help them better manage the safety of the ward. The system will be designed with service users and staff and then tested on wards.

At the moment, when safety data is collected (e.g. about incidents), it is usually collected afterwards and service users’ viewpoints are rarely included. Our research has shown that patients are happy to report safety issues in general hospitals but this has not been tried on mental health wards.

The project will have three phases. Phase 1 will develop a way to collect information from service users about how safe they are feeling and explore how this information might be presented to staff. We will do this by reviewing the evidence about collecting safety data from people in hospitals and carry out interviews with service users and staff. Secondly, we will hold workshops with service users and staff to co-design the system. In Phase 2 we will carry out small-scale testing on two wards for eight weeks and then modify the system if required. Phase 3 will be an in-depth study for nine months on six wards. This will tell us how useful the system is and if it shows promise.

Why have I been invited?

You have been invited because you are a member of staff on an acute mental health ward and you have responded to our advert.

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. Interviews will be carried out by telephone or video (via Microsoft teams). The interview will take no more than one hour. Before the interview we will ask you to give your consent verbally (based on a Consent Form you will be sent in advance), to say that you are taking part voluntarily. You are free to withdraw at any time and without giving a reason and your data deleted. You are also able to decline to comment on specific issues without giving a reason. During the interview you will be asked for your opinion on how service users might help to improve safety on mental health wards.

What are the possible advantages and disadvantages of taking part?

We hope you will find the subject of the interview and sharing your views interesting. The information you provide will help us develop our research which might lead to improved safety on wards. Participants will be offered certificates confirming participation in a focus group that can be used as evidence in revalidation or appraisal portfolios. We appreciate that you have a busy schedule and aim to minimise disruption when we conduct the interview by scheduling a time and place that is most convenient for you. Depending on your experiences you may find talking about them upsetting, if this is the case we will ensure you are provided with sources of support.

What do I have to do if I want to take part?

If you decide that you would like to take part please contact John Baker on J.Baker@leeds.ac.uk.

Data management: What will happen to the information I provide?

The University of Leeds is the sponsor for this study. This means that we are responsible for looking after your information and using it properly. We will use information from you in order to undertake this study and will act as the data controller for this study. The University of Leeds will keep identifiable information about you until the end of the study. 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. All information that is collected about you for this research will be kept strictly confidential in accordance with the Data Protection Act (2018) and General Data Protection Regulation (2018).

What information will we collect from you?

Personal details: We will always collect the minimum amount of personal data required to carry out our research. We will never share this information with anyone outside the research team. If you decide to take part in the study you will be asked to provide us with a name and means of contacting you, e.g. an email address or telephone number. We assign each interviewee a code (letters and numbers e.g. WSQS12 and we use this code to label the interview data file (see below). Your contact details and participant code will be kept confidential.

All participants personal details will be stored in a spreadsheet which will be password protected and stored on University of Leeds secure servers. Only researchers carrying out interviews have access to this file (unless it is requested for audit by the University of Leeds). The spreadsheet will be securely deleted at the end of the study. The deletion of this file breaks the link with the transcripts which are then completely anonymous.

If you would like to be sent a summary of the study results you will be asked to provide an email address when you complete the consent form. This email address will be stored securely in a password-protected mailing list spreadsheet on University of Leeds secure servers and not linked to any data.

Interview data: With your prior agreement we will take an audio recording of your interview, we label this file with the code we assign to each participant (see above). All digital recordings will be encrypted and stored in a folder on a secure University of Leeds server that only the research team can access. The recordings will be transcribed for analysis by a company that is an approved supplier of the University of Leeds and is bound by a confidentiality agreement. To do this we upload recordings to the transcription company secure server and download the completed transcript from the same place when it is ready. Once we have received the transcript we will delete the original recording. At this point the transcript will be edited to make the text anonymous, this means we will delete any references to names or places or specific events that might make it possible to identify you.

We will use this anonymised transcript to carry out the analysis of the interviews. We will use direct quotations from some interviews in our research report and other publications but these will never be attributed to a specific individual, we use a description instead, e.g. ‘Interviewee 3: Mental health nurse’. Anonymised transcripts will be stored on the University of Leeds secure servers for five years from the end of the study before being securely deleted. They will not be shared with other researchers.

If you change your mind about having taken part you can withdraw your data from the study for up to one week after your interview by contacting the Principal Investigator.

To read more about how data is used in research please see the University of Leeds Research Privacy Notice that can be found here https://dataprotection.leeds.ac.uk/research-participant-privacy-notice/ or on request from the research team.

If you have any further queries about how we use your information please contact the Principal Investigator Professor John Baker at J.Baker@leeds.ac.uk  or 0113 343 1271, or the University of Leeds Data Protection Officer on dpo@leeds.ac.uk or 0113 343 7641

What will happen if I reveal information that indicates professional negligence or a risk of harm to myself or others while participating in the interview?

If you disclose information that indicates professional negligence, a risk of harm to yourself or others, confidentiality will have to be broken and the matter would have to be reported. This may include the decision to disclose the information that you have provided, your identity, and the identity of any individuals you have named, to an appropriate person within the NHS Trust who may decide to take further action.

What will happen to the results of the research study?

The results of this research study (including anonymised parts of interview transcripts) could be included in articles for academic journals, presentations at academic conferences and local educational meetings.

What if there is a problem?

If you have a concern about any aspect of this study you should contact the Principal Investigator Professor John Baker who will do his best to answer your questions. He can contacted at J.Baker@leeds.ac.uk or 0113 343 1271. If he is unable to resolve your concerns, or you wish to make a complaint regarding the study, please contact the University of Leeds, Faculty of Medicine, Head of Research Integrity and Governance on 0113 343 4897 or by email to C.E.Skinner@leeds.ac.uk.

Who is organising and funding the research?

This study is funded by the National Institute for Health Research (NIHR) and overseen by the University of Leeds. It is being carried out by researchers at the University of Leeds and Bradford Institute for Health Research.

Who has reviewed the study?

This study has been reviewed and given favourable opinion by the University of Leeds School of Healthcare research ethics committee (Reference number: HREC 19-028).

What do I do now?

If you require any further information or clarification on any aspect of this study, or would like to discuss participating in the study please contact John Baker on J.Baker@leeds.ac.uk

Thank you very much for taking the time to read this information