School
Of
Medicine
& Biomedical Sciences.
Health Care Professional Participants Information Sheet
Study Title:
Protocol Ref:
Version:
Patient Decision Aid for Type 2 Diabetes
ZH25
V1-09/03/09
Part 1 tells you the purpose of this study and what will happen to you if
you take part.
Part 2 gives you more detailed information about the conduct of the
study.
Part 1
We would like to invite you to take part in an evaluation of the Patient Decision Aid for
Type 2 Diabetes (PANDAs) research study. This evaluation will find out the Health Care
Professional’s experiences of being trained and in using and delivering 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 the experiences of Health Care
Professionals in using the Patient Decision Aids and to assess how different factors
may influence the patient/Health Care Professional experience.
2. Why have I been invited?
You have been invited because of your experience in using the Patient Decision Aid
during the study. Your views and opinions will help us to understand the how patients
make decisions about their treatment. You can also provide information on the
facilitators of, and barriers to, decision-making in general practice.
A total of 10healthcare providers will be invited to participate in the study. We will
also be interviewing 10patients with type 2 diabetes who have used the Decision Aid.
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3. Do I have to take part?
Your participation is entirely voluntary and it is up to you to decide. We will describe
the study and go through this information sheet with you when you come for the
interview. 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.
4. What type of study is this?
This is a qualitative study using the method of in-depth face-to-face interviews.
Sometimes interventions can work separately or by a combination of factors; the aim
of the evaluation is to assess how different factors may influence the patient/Health
Care Professional experience. By recording and analysing the consultations and
interviews we will be able to find out the Health Care Professional’s experiences in
using the Decision Aid in a consultation.
5. What will happen to me if I take part?
If you agree to take part in this part of the study your consultation with a patient who
will be using the Patient Decision Aid will be audio-taped. After the consultation,
within 2 weeks , you will participate in a one-to-one interview which will be conducted
by the researcher. Before the consultation and interview, the researcher will go
through the Participant Information Sheet with you. If you agree to participate, the
researcher will ask you to sign a consent form.
The researcher will ask questions related to your experience in helping patients to
make decisions about their diabetic treatment by using the Patient Decision Aid. The
researcher will record the consultation and interview using an audio tape recorder.
The purpose of the recording is to allow the researcher to capture all the information
discussed during the consultation and interview, which is important for them to
analyse later. The interview will take about 30 minutes.
6. What will I have to do?
During the interview you will be required to answer questions based on your personal
experience. However, you can refuse to answer any questions which you feel are
uncomfortable and you can stop the interview at any time.
7. 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.
8. 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.
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9. Is the purpose of this study educational?
Yes. Part of the data from this research will be used for a PhD study.
This completes Part 1.
If the information in Part 1 has interested you and you
are considering participation, please read the additional
information in Part 2 before making any decision.
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Part 2
10.
What will happen if I don’t want to carry on with the study?
You can withdraw from the study without giving a reason.
11.
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: 0114 2269785 or Professor Nigel Mathers on: 0114 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 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.
12.
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.
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13.
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.
14.
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.
15.
Who has reviewed the study?
This study has been reviewed and given favourable opinion by North Sheffield
Local Research Ethics Committee.
16.
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: A.Bradley@sheffield.ac.uk
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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 or
Fax: 0114 2422136
Email: A.Bradley@sheffield.ac.uk
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: n.mathers@sheffield.ac.uk
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
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