Participants Information Sheet
Study Title: Patient Decision Aid for Type 2 Diabetes
Protocol Ref: ZH25
Version: V2-030809
Part 1
We would like to invite you to take part in an evaluation of the Patient Decision Aid for Type 2 Diabetes (PANDAs) study. The evaluation process involves audiotaping your consultation with the Health Care Professional. It will also include a 30 minute (approximately) audiotaped interview with a researcher within two weeks of the initial consultation to find out about your experience in using the Patient Decision Aid.
Before you decide whether to participate, you need to understand why the research is being done and what it would involve. Please take time to read the following information carefully; talk to others about the study 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.
1. What is the purpose of the study?
This evaluation is part of the Patient Decision Aid for Type 2 Diabetes (PANDAs) study. The purpose of this evaluation is to find out your experience discussing your diabetes with the Health Care Professional, your experience of using the Patient Decision Aid,and to assess how different factors may influence the patient/Health Care Professional experience.
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2. Why have I been invited?
You will already have been approached to take part in the Patient Decision Aid for Type 2 Diabetes study as your GP/Practice Nurse has identified that your diabetes might be controlled better. We are also trying to assess patient’s experience of using the decision aid.
A total of approximately 10 people with type 2 diabetes who have agreed to take part in the Patient Decision Aid for Type 2 Diabetes study will be invited to participate in the evaluation process of the study.
3. Do I have to take part?
Your participation is entirely voluntary and it is up to you to decide whether or not to take part. We will describe what we are aiming to find out in this study and go through this information sheet with you when you attend the surgery. We will then ask you to sign a consent form to show you have agreed to take part. You are free to withdraw at any time, without giving a reason. This will not affect your treatment or the standard of care that you receive.
4. What type of study is this?
This is known as a qualitative study that uses the method of face-to-face interviews. Sometimes, we don’t know what the problems faced by people attending the clinic are, for example, the problems encountered by people with type 2 diabetes when making decisions about their treatment. To find out, we need to interview people with type 2 diabetes who have made treatment decisions before. By recording and analysing their conversations, we are able to obtain useful information from them and find out the problems they have experienced when making decisions about their treatment.
5. What will happen to me if I take part?
If you agree to participate, the researcher will ask you to sign a consent form. The researcher will arrange for your consultation in the PANDAs study, with the Doctor or nurse, to be audio-taped. A follow-up interview will be conducted either immediately after your consultation with the doctor/nurse or at your home within two weeks.
During the follow-up interview the researcher will ask questions related to your experience with the doctor/nurse and using the decision aid. He/she will record the conversation using an audio tape recorder. The purpose of the recording is to allow the researcher to capture all the information discussed during the interview, which is important for them to analyse later. The interview will take about 30 minutes.
6. What will I have to do?
You are required to answer the questions based on your personal experience during the interview. However, you can refuse to answer any questions which you feel uncomfortable and you can stop the interview at any time.
7. What are the possible disadvantages and risks of taking part?
During the interview, sometimes, you might be asked questions about certain topics which are sensitive or may upset you. You can refuse to answer any questions which you feel uncomfortable with, or you can stop the interview anytime.
8. What happens when the research study stops?
Your GP/ Nurse will continue to provide medical care for you.
9. What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be looked into. The detailed information on this is given in Part 2.
10. Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. The details are included in Part 2.
11. Is the purpose of this study educational?
Yes. Part of the data from this research will be used for a PhD study.
Part 2
12. What will happen if I don’t want to carry on with the study?
You can withdraw from the study without giving a reason and without affecting your care.
13. What if there is a problem?
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (Contact Dr A Bradley on: 2269785 or Professor Nigel Mathers at: 2715922). If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from the GP or the local Primary Care Trust.
In the 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 a legal action for compensation against the NHS but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you.
14. Will my taking part in this study be kept confidential?
The recorded conversation will be transcribed by a designated secretary. Only the interviewer and the secretary will have access to the audiotape. All information will be coded and anonymised. Once the transcript has been completed and checked by the interviewer for accuracy, the audiotape will be erased by the secretary in the presence of the interviewer.
The information we have collected as paper copies will be stored under lock and key, while the electronic data can only be accessed with a secure password. Only the researchers, sponsors, regulatory authorities and Research & Development auditors will have access to the data.
The data we collect will be used only for the purpose of this research; if data were to be used for future studies, further Research Ethics Committee approval will be sought. The transcripts will be kept for five years according to the Medical Research Council guidelines.
All information which is collected about you during the course of the research will be kept strictly confidential, and any information about you which leaves the surgery will have your name, telephone and address removed so that you cannot be recognised.
15. Involvement of the General Practitioner/Family doctor (GP)
Your GP will be informed about your participation in this study.
16. What will happen to the results of the research study?
The results of this study will be published in medical journals. A summary of the results will be sent to you by post and you will be invited to attend a public seminar.
You will not be identified in any report, publications or presentation without seeking your full consent. Direct quotes from the interviews may be used in reports and publications; however, the quotes will be anonymised to ensure that you cannot be identified.
17. Who is organising and funding the research?
The Sheffield Health and Social Research Consortium is the sponsor of this study and the Department of Health will be funding the research.
18. Who has reviewed the study?
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee to protect your safety, rights, well-being and dignity. This study has been reviewed and given favourable opinion by North Sheffield Local Research Ethics Committee.
19. Further information and contact details.
General Information about research
You can visit the following web site to obtain more general information about research:
INVOLVE – Promotes public involvement in the NHS: http://www.invo.org.uk
Specific information about this research project
Dr Alastair Bradley
Academic Unit of Primary Medical Care
University of Sheffield
Sam Fox House
Northern General Hospital
Herries Road
Sheffield
S5 7AU
Tel: 0114 2269785
Fax: 0114 2422136
Email:
Advice as to whether you should participate
Dr Alastair Bradley
Academic Unit of Primary Medical Care
University of Sheffield
Sam Fox House
Northern General Hospital
Herries Road
Sheffield
S5 7AU
Tel: 0114 2269785
Fax: 0114 2422136
Email:
Who you should approach if unhappy with the study
Professor Nigel Mathers
Academic Unit of Primary Medical Care
University of Sheffield
Sam Fox House
Northern General Hospital
Herries Road
Sheffield
S5 7AU
Tel: 0114 2715922
Fax: 0114 2422136
Email:
OR
Using the NHS Complaint Procedures, which you can obtain from the surgery or your local NHS Primary Care Trust. You can visit the following web site for more details:
http://www.nhs.uk/England/AboutTheNhs/ComplainCompliment.cmsx
PIS Qualitative Interview Patient / Version 2 / 030809