Information Sheet for National Student HCP study
Version 1.3 08/09/2020
Dr Andy Soundy and Mr James Bateman,
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
1. Study title
Mental Health Screening, Intervening and Training (SiT) of Student Health Care Professionals; a randomised control trial
You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.
Thank you for reading this.
3. What is the purpose of the study?
The purpose of this study is to use and understand a mental health screening tool and narrative-based intervention that is able to support interactions with patients. We will be testing an e-based form of training and all student health care professionals will receive links to e-lectures as part of the training and an opportunity to discuss their own screening results with Dr Soundy. We are asking whether you would beprepared to consent to completing a questionnaire that gathers more details about your opinion of the ideas after the session. We have undertaken pilot research and identified particular benefits that we need to establish further. You assistance would prove vital to this.
4. Why have I been chosen?
You have been chosen to take part because you are a student healthcare professional who could benefit from receiving training. As part of the development of this intervention it is essential that your views, experiences and perceptions of intervention are incorporated and help inform future courses or training events.
5. Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to consent to participate you will keep this information sheet as something to which you might choose to refer back. You will be asked to sign a consent form to say you are happy to take part in the study. If you decide to take part you are still free to withdraw at any time without giving a reason. Please be aware that once the data has been published then you will not be able to withdraw. It is expected the date after which it will not be possible to withdraw will be 1 January 2021. To remove your responses from the research please take a note of your Unique Identification Number written on your questionnaire and email Dr A Soundy (A.A.Soundy@bham.ac.uk) to have your completed questionnaire removed from the data that is gathered.
6. What will happen to me if I take part?
You will be allocated to a control group or an intervention group. For both groups you will be required to complete a short set of questionnaires/outcome measures beforeand after (straight after the session)the training session has been completedand then at follow up (12weeks). These will be sent via an attached excel document. These questionnaires take 10 minutes to complete. The intervention group will consider the impact of receiving information relevant to the concepts of illness narratives and the psychology of illness.
At a later point we will invite some students to take part in an interview about the study.
7. What do I have to do?
You will view one e-based lecture delivered by Dr A Soundy. This lecture will either provide you with a control condition or the intervention group. The intervention group will be required to complete some tasks in addition to the lecture. At the start of the lecture and at the end of the training lecture you will be asked to answer a set of questionnaires that would include demographic details about yourself as well as open questions around your views, attitudes and perceptions of the session and its content. IF you are in the control condition you will complete a set of outcome measures, be required to wait two hours and fill in the outcome measures again. After 12 weeks you will be offered the intervention.
Please note filling in the questionnaires is optional, it is research and part of a study notpart of your requirement as a student. These questionnaires take a total of 10 minutes to complete each time. Some people will be asked to take part in an interview, although taking part is not obligatory. Once you have begun any part of a questionnaire or interview you will be able to keep the vouchers even if you choose to leave during the process.
8. What are the possible disadvantages and risks of taking part?
Giving time to this training may impact on your day. This training is not a core part of your role as a student. When you undertake the screening part of the study it requires you to think of, and talk about, a difficult challenge you are facing now. No adverse effects have been documented in our pilot work.
9. Will my taking part in this study be kept confidential?
All information that is collected about you during the course of the research will be kept strictly confidential. All questionnaires following the session will be anonymous and will be kept in a locked office in a secure building at the University of Birmingham. This data will be kept for 10 years and in accordance with GDPR (2018).
10. What will happen to the results of the research study?
The results will be presented within the university, used for conference presentations and publications which might include journals or a book. We will prepare a presentation of the results for you to help as part of the training and to give you an idea of the different study outcomes before publication of the work is achieved.
11. Who has reviewed the study?
The University of Birmingham ethics committee has reviewed this study.
Review number: ERN_18-1970D.
12. Contacts for further Information
Dr A Soundy
Email: A.A.Soundy@bham.ac.uk Phone: 0121 4148385
Mr J Bateman