Kadoorie Centre for Critical Care
Research and Education,
John Radcliffe Hospital,
OXFORD. OX3 9DU
Tel: 01865 922440
Fax: 0844 3584470
ICON 3 - Intensive Care Outcome Network Study
A study to gain a better understand of the long-term effects of treatment
in an intensive care unit
Funded by: The Bupa Foundation Ethics reference: 11/SC/0172
Chief Investigator: Dr J Duncan Young
PATIENT INFORMATION SHEET
Please read carefully before filling in the questionnaires
You are being invited to take part in a research study. Before you decide whether to take part, it is important for you to understand why the research is being done and what it would involve for you. You should understand enough about it to be able to make an informed decision. Please take time to read the following information carefully and discuss it with others if you wish. Take time to decide whether or not you wish to take part. There is a telephone number at the top of this leaflet which you can ring if there is anything that is not clear, or if you would like more information.
What is the purpose of the study?
We are collecting data relating to the long-term health and well-being of patients recovering from treatment on an intensive care unit (ICU) in the UK. By following up patients treated on an ICU for more than 24 hours we can gain a greater understanding of the long-term effects of ICU treatment.
We want to discover what happens to patients after they have been treated on an ICU, and, most importantly, what changes (if any) there may be to a patient’s well-being and how they feel since treatment on an ICU.
Why have I been invited?
You will shortly be invited to take part in the study because we have been told that you have recently been treated on an ICU for more than 24 hours.
What will happen if I agree to take part?
Patients who wish to enter the study are asked to sign a consent form. Signing this form indicates to the ICON team that you allow:
- study questionnaires to be sent to you;
- the ICON team to let your GP know some of your questionnaire results;
- the ICON team to access Government records to determine if you have
future episodes of ill-health; and
- data to be collected about the duration of your stay in the ICU, and why
you were admitted. These data would be collected directly from the
hospital in which you were treated.
If you agree to help this study, you will receive a pack of up to 6 different questionnaires. Each questionnaire will take about 5 minutes to complete. You will also receive a FREEPOST envelope to return the completed questionnaires to us. If you have not returned the questionnaires (or told us that you do not wish to participate in the study) after three weeks, we will routinely send a duplicate set of questionnaires to you in case you did not receive the first set. You will not be required to complete both sets of questionnaires.
If we don’t hear from you within three weeks of sending you the duplicate set of questionnaires, a member of the ICON study team will attempt to telephone you. The purpose of telephoning you will only be to find out whether you received the questionnaires, and give you an opportunity to ask questions if you have any queries about the study. The person telephoning you will not pressure you to take part in the study, and will ring back at a different time if it is not convenient for you to speak at the time they ring you initially, or if you have not had sufficient time to study the patient information sheet.
Full participation in the study will involve completing three sets of questionnaires at 3 months, 12 months and two years after you were discharged from intensive care. You will be able to withdraw your participation at any time during the duration of the study without giving a reason. If you withdraw part of the way through the study, any information you have already sent to the study office in the form of answers to questionnaires will be retained and used in the study, but we will not send you any more questionnaires or attempt to telephone you after we receive notification that you no longer wish to take part in ICON. You can withdraw your participation by returning blank questionnaires to us, by writing to us at the postal or email addresses above, or by telephoning us.
Do I have to take part?
It is up to you to decide whether or not to take part. Even if you agree to take part and sign the consent form, you are still free to withdraw at any time, without giving a reason, and without your care being affected in any way. You can withdraw from the study by contacting Judith Bishop, Study Co-ordinator, ICON study, Kadoorie Centre, John Radcliffe Hospital, Oxford, OX3 9DU (telephone: 01865 922440, email email@example.com). Your participation in the study would cease after your data has been anonymised (see “Would my taking part in this study be kept confidential?” below).
What are the possible benefits and disadvantages of taking part?
There will be no direct benefits to you if you take part. However we hope your participation will improve the care of patients treated on intensive care units in the future.
Would my taking part in this study be kept confidential?
Any information collected about you during the course of the study will be kept strictly confidential and held securely. All data collected will be “anonymised”- that is, any information that leaves the study office will have all names and addresses removed so that individuals cannot be recognised from it.
Responsible members of the University of Oxford or the NHS Trusts involved in the study may be given access to data for audit purposes to ensure we are complying with regulations.
Will you contact my GP?
We routinely contact your GP for two reasons. The first is to inform your GP that we intend to invite you to take part in the study. The second reason is to advise your GP if your questionnaire results indicate that you may be suffering from stress or depression. We will only contact your GP with this information if you give us consent to do so.
What will happen to the results of the research study?
The study is estimated to take three years, commencing in early 2011. We hope to publish the results by 2015. We plan to make the results available on a new website that will be activated at the end of the study (www.iconstudy.org).
Who is sponsoring or funding the study?
The BUPA Foundation has funded this study. The University of Oxford is acting as sponsor for the study, and as such has taken on the legal responsibility for the management of the study.
Given the nature of this study, it is highly unlikely that you will suffer harm by taking part. However, the University of Oxford, acting as the Research Sponsor, has arrangements in place to provide for harm arising from participation in the study.
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 interests. This study has been reviewed by NRES Committee South Central – Berkshire and been given a favourable opinion. The ethics reference number for the study is 11/SC/0172.
The study has also been given permission from the National Information Governance Board (NIGB) which allows us to have your name, address, NHS number, and GP details as well as the dates of your hospital and ICU admissions. We are allowed to hold this information in order to invite you to take part in the study, but if you tell us you do not wish to take part, we will delete your information from our records.
What happens if I have any questions, concerns or complaints about the study?
If you have any questions concerning the study, please contact Judith Bishop, the Study Co-ordinator on 01865 922440.
If you have any comments, concerns or complaints about any aspect of the way you have been approached or treated during the course of this study, you can write to Dr J D Young, ICON Study, Kadoorie Centre, John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, or you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on 01865 572245 or the head of CTRG (Ms Heather House), email firstname.lastname@example.org.
Thank you for taking the time to read this information sheet.
If you would like to take part in the study but would prefer us to call you rather than send you paper questionnaires, please let us know.