Why are we doing this research study?
Hip and knee arthritis causes pain which limits daily activities and can make it difficult to work. Hip and knee replacements can relieve pain and improve function and can help many patients of working age continue working or get back to work.
We understand the issues patients face when returning to usual activities and work after hip and knee replacements. We have used this understanding to improve care and develop a support programme to help people return to work and usual activities.
Why have I been invited to take part?
You have been invited to take part because you are going to receive a hip or knee replacement at one of the hospitals participating in this study and you have been in work before your operation.
What will happen if I take part in this study?
If you are about to have a hip or knee replacement, currently work and are intending to return to work after surgery, then a member of your care team has identified you as a ‘return to work patient’. With your permission they will pass your details to a member of the research team who will explain this study to you and seek your consent to participate.
If you decide to take part in the study, you will be allocated to one of the two study groups at random after completing the consent form. You are allocated to a group using a computer, meaning you, your care team or the researchers cannot choose which group you are in.
The two study groups are the ‘OPAL Support Programme’ and ‘Study Standard Care’.
Possible benefits and risks of taking part
There may not be a direct benefit to you.
We have designed the programme to help people return to usual activities after surgery, including work. However, we do not know if it is better than the standard care currently given after hip or knee replacement. This study will help us to assess this.
There are no particular risks associated with this study. We appreciate that taking part will involve your time.
Do I have to take part?
You are free to decide if you wish to take part in the study. Your decision will not impact your routine health care.
You do not have to decide straight away. A member of the research team can contact you later to answer any questions that you have. If you want to take part, you will be asked to complete a consent form.
What will happen if I don’t want to carry on in the study?
Your participation is voluntary, and you are free to withdraw at any time, without giving any reason. This will not affect your working and legal rights and will not affect your current or future health care.
If you choose to withdraw from the study, we will:
- Use all the information collected up to the point of withdrawal to be used in the data analysis, with your permission.
- Ask if we can continue to collect routine hospital data.
If you lose capacity to consent during the study, you would be withdrawn from the study. Any identifiable data that has already been collected with consent would be kept and used in the study, but no further data would be collected.