Study Information

Preparation for Knee Surgery Study
Waitemata District Health Board
Ethics Ref: NZ/1/D574117

Lead Investigator:

Debbie Bean Contact: debbie.bean@aut.ac.nz or
Deborah.Bean@waitematadhb.govt.nz

You are invited to take part in a study on preparation for knee replacement surgery. Whether or not you take part is your choice. If you don’t want to take part, you don’t have to give a reason, and it won’t affect the medical care you receive. If you do want to take part now, but change your mind later, you can pull out of the study at any time.

This Participant Information Sheet will help you decide if you’d like to take part. It sets out why we are doing the study, what your participation would involve, what the benefits and risks to you might be, and what will happen after the study ends. We will go through this information with you and answer any questions you may have. You do not have to decide today whether or not you will participate in this study. Before you decide you may want to talk about the study with other people, such as family, whānau, friends, or healthcare providers. Feel free to do this.

If you agree to take part in this study, you will be asked to sign the Consent Form on the last page of this document. You will be given a copy of both the Participant Information Sheet and the Consent Form to keep.

WHAT IS THE PURPOSE OF THE STUDY?
This study is designed to test whether it is practical to provide additional support to people while they are waiting for knee replacement surgery, to help them prepare for surgery. The study will provide people with information on what to expect during recovery, and skills to help reduce stress or anxiety around the time of surgery, or both. If the study shows that providing this support is useful, we will use these strategies in a larger trial in the future.

At the moment, people do not receive this type of support before surgery. If you take part in the study, you will receive support in addition to your usual care. The study is being run by researchers from Auckland University of Technology (AUT) and Waitemata District Health
Board (WDHB). If you have any questions about the study, please just ask. The study has been approved by the New Zealand Health & Disability Ethics Committee (HDECS).

WHAT WILL MY PARTICIPATION IN THE STUDY INVOLVE?
You have been invited to participate in this study because you are waiting for a knee replacement. If you are interested in taking part, a member of the research team will phone you to see whether you meet other inclusion criteria for the study and will ask you a range of questions about your current experiences and expectations for surgery. The additional support that people receive during this study is divided into two modules. For each module, people will be scheduled for a phone appointment with one of the researchers (Debbie Bean and Natalie Tuck). After the phone call, the researcher will provide you with either a workbook and DVD, or online resources for you to work through in your own time. It will be your choice whether you use the workbook/DVD or the online version. After two weeks, you will receive a second phone appointment. One of the modules will focus on topics such as: what to expect after surgery, goals for recovery, and managing pain after surgery. The other module will focus on topics such as: the link between stress and pain, and skills to reduce stress around surgery to optimise your recovery. We expect each phone call will take no more than one hour, and the time you spend learning more about the topics in your own time is up to you, but we ask that you allow at least 60 minutes per module.

If you choose to take part in the study, you will be asked to fill in a questionnaire before and after each module and again six months after your knee surgery. Each questionnaire will take about 20 minutes to complete, and you can fill it in either online or on paper. The questionnaire will ask about your pain, your expectations for surgery, your mood, your physical function, and what you thought of the support and information you received.

The support provided in this study is limited, so we recommend that if you are feeling very distressed or anxious that you seek help from your GP in the first instance. There are also community support services available, such as Lifeline (0800 543 354) or Healthline (0800 611 116).

If you would rather not be phoned by the research team about the study, you can let us know by emailing debbie.bean@aut.ac.nz, or texting 021 150 3131, and then we will not phone you. If you are happy to indicate a reason why you would not like to be contacted. that would be appreciated (e.g. “too busy” or “don’t speak English”). It helps us to know if a particular type of person is not taking part in research so we will know how well the results apply to all patients.

WHAT ARE THE POSSIBLE BENEFITS AND RISKS OF THIS STUDY?
There are no foreseeable health risks from the study, though it is possible that some people may find it uncomfortable to discuss medical procedures or topics such as pain and stress. The researchers will be sensitive to your individual needs and you do not need to discuss anything you do not wish to. The possible benefits of taking part in the study are that you may feel better prepared for surgery and this may help you to make a good recovery. If you choose to take part in the study, we will ensure that you receive the phone calls and materials in a timely and professional manner, but the research team does not have any influence over the surgery itself or usual healthcare that you receive.

WHO PAYS FOR THE STUDY?
The study is funded by internal research funding from Auckland University of Technology (AUT). If you choose to participate, you will receive a $30 gift voucher as a token to thank you for your time and effort.

WHAT IF SOMETHING GOES WRONG?
If you were injured in this study, you would be eligible to apply for compensation from ACC just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will automatically be accepted. You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery. If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover.

WHAT ARE MY RIGHTS?
Taking part in the study is your choice, you are free to decline to take part or to withdraw from the research at any time, without experiencing any disadvantage. You have the right to access all the information we collect about you (for example your questionnaire scores). All the information we collect about you, including whether or not you choose to participate, will be kept private and confidential. If you choose to take part, we will assign you a code number so that information about you can be kept separate from any identifying information (such as your name or phone number). We will store your information on the AUT secure computer server and/or in locked filing cabinets.

WHAT HAPPENS AFTER THE STUDY OR IF I CHANGE MY MIND?
After the study, we will keep your information for 10 years and then any paper files will be shredded and electronic data files will be deleted. We will analyse the study results and use the findings to help us develop a larger trial. We will also write the results up and publish them in an academic journal and present them at healthcare meetings. The results presented will be averages for the whole group of participants and no information that could identify you will be included. If you provide us with written or verbal feedback about the treatment (e.g. what you liked or disliked) we may use your quotes but these would be anonymous so no one could identify you.

If you would like to receive a copy of the study results we will send you a copy. It may take up to 8 months to receive the results, as it will take this long to complete the study.

WHO DO I CONTACT FOR MORE INFORMATION OR IF I HAVE CONCERNS?
If you have any questions, concerns or complaints about the study at any stage, you can contact:
Debbie Bean, Senior Research Fellow, Waitemata District Health Board & AUT
Phone 921 9999 ext. 7157
debbie.bean@aut.ac.nz / Deborah.Bean@waitematadhb.govt.nz
Natalie Tuck, Senior Research Fellow, Waitemata District Health Board & AUT
Phone 921 9999
natalie.tuck@aut.ac.nz

Health & Disability Advocates:
If you want to talk to someone who isn’t involved with the study, you can contact an independent health and disability advocate on:
Phone: 0800 555 050 Fax: 0800 2 SUPPORT (0800 2787 7678) Email: advocacy@advocacy.org.nz

Māori Cultural Support:
For support, talk to your whānau in the first instance. Alternatively you may contact the administrator for He Kamaka Waiora Māori Health Team on 09 486 8324 ext. 2324.

If you have any questions or complaints about the study, you may contact the Auckland and Waitematā District Health Boards' Māori Research Committee or Māori Research Advisor by phoning 09 486 8920 ext. 3204.

Ethics Committee :
You can also contact the health and disability ethics committee (HDEC) that approved this study on:
Phone: 0800 4 ETHICS
Email: hdecs@moh.govt.nz