PARTICIPANT INFORMATION SHEET

Digital Support For People With Chronic Pain Who Are Reducing Prescription Opioids

Project Sponsor: University of Sydney

Principle Investigator: Professor Paul Glare

Associate Investigators:  Associate Professor Claire Ashton-James, Dr Ali Gholamrezaei, Michael Magee, Amy Gray McNeilage

Location: Pain Management Research Institute, Ground floor, Douglas Building, Royal North Shore Hospital, St. Leonards NSW 2065

 1.         Invitation

We invite you to participate in research about digitally delivered support for patients with chronic pain who are reducing their opioid dose. Before you decide whether you wish to participate in this study, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish.

2.         ‘What is the purpose of this study?’

This research evaluates whether providing education, motivation, and emotional support using digital health technologies can benefit patients with chronic pain who are reducing their opioid medications and improve their pain and well-being. 

3.         ‘Why have I been invited to participate in this study?’

You are invited to participate in this study if you are currently taking prescribed opioid medications for chronic pain, and either your doctor has recommended that you reduce your opioid dose, or you are currently reducing your opioid dose under the supervision of your doctor. 

4.         ‘What if I don’t want to take part in this study, or if I want to withdraw later?’

Participation in this study is voluntary. It is completely up to you whether you participate. If you decide not to participate, it will not affect your relationships with your treating clinicians or the treatment you receive now or in the future. 

If you wish to withdraw from the study, you can do so at any time without having to give a reason. 

If you choose to withdraw, you can inform the research team by sending an email to support4pain.study@sydney.edu.au or by phone call to 0480490896 during office hours. They will send you the ‘Participant Withdrawal of Consent Form’ to sign.

If you withdraw from the study, your data and information will be deleted from study records and will not be used in future research, unless you agree to your de-identified (anonymised) data being used.

Note: The principal investigator may remove a participant from the study at any time if they feel it is in their best interest or that their safety may be at risk due to unanticipated health issues or not following study procedures.

5.         ‘What does this study involve?’

If you decide that you would like to participate, the following will happen:

1. You will complete a short online eligibility form. This will take around 5 minutes to complete. If you are eligible to participate, you will be asked to provide your contact information and sign the consent form online.  

2.  Once you have signed the consent form, you will be asked to complete an online survey with questions such as about your age, gender, pain, and health status. The baseline survey will take around 15 minutes to complete. After completing this survey, the research team will contact you by email and text message to confirm your eligibility and provide you further instructions about the study. 

3. As part of this study, you will be randomly assigned to receive one of two digital health supports. This assignment is done by a computer but is similar to flipping a coin. The digital health supports, delivered by mobile phone and email, are designed by a team of researchers, patients, and clinicians. They provide education, motivation, and emotional support to people with chronic pain while reducing their opioid medications. You will receive more details about the digital support once it is known which you will receive. 

4. This is a double-blind study. This means that the researchers, participants, and participants’ doctors will not know which digital support the participant is receiving. You can inform your doctor about your participation in this research. However, you will be asked not to talk to your doctor or the researchers you are in contact with about the details of the digital support you are receiving unless it is directly requested by your doctor or a research team member or you decide to do so for safety reasons. 

5. This digital health support is not replacing any care you would otherwise receive from your doctor or other healthcare professionals. It is provided in addition to your usual care, and you will continue your treatment under their supervision. 

6. Your participation in the study will last for 12 weeks starting from the day you sign the consent form. You will complete short questionnaires every month for 3 months that ask about your pain and other symptoms, function, mood, thoughts, and medication changes. Each monthly survey will take around 5 minutes to complete. These help us to evaluate whether the digital support is helpful. These will be sent to your mobile phone and/or email and will be completed online. You will receive text messages as reminders to complete the questionnaires.

7. After 12 weeks, you will be asked to complete a feedback survey and may be invited to participate in an interview over the phone (audio-recorded) which will take around 30 minutes to give feedback about the digital support you received. Participating in the feedback interview is optional and not a requirement of the study. 

Please note, that the digital support in this study is not a crisis service and if you are in crisis or it is a health emergency, you should contact your nearest hospital or an emergency health service available in your area. If you experience a flare-up of pain or have any other pain-related concerns, you should contact your doctor or clinician as you would normally. 

6.         ‘How is this study being paid for?’

This study is supported by a grant to The University of Sydney from the Ernest Heine Family Foundation.

7.         ‘What are the alternatives to participating in this study?’

The digital health support is not replacing the care that you are receiving from your doctor and other healthcare professionals. If you decide not to participate, your treatment will continue as usual. 

8.         ‘Are there risks to me in taking part in this study?’

We do not expect you to experience any harm as a result of participating in this study. If any unexpected consequences occur during your participation or you feel distressed by this study, please contact the research team by email address support4pain.study@sydney.edu.au for advice, or contact your GP, or attend your local Hospital Emergency Department.

We also encourage you to reach out to the following services if needed:

·            For mental health support, call Lifeline: 13 11 14 (24 hours)

·            For withdrawal support, contact the Alcohol and Drug Information Service: 1300 340 357 (24 hours)

·       For chronic pain support, call the Pain Link Peer Support Service: 1300 340 357 (leave a message for call back service)

Please note, that the study phone number used by the SMS software cannot be contacted by call or text messages. The email address support4pain.study@sydney.edu.au and other study phone number 0480 490 896 are NOT for urgent medical/mental health needs.

9.         ‘What happens if I suffer injury or complications as a result of the study?’

If you suffer any injuries or complications because of this study, you should contact the research team by the provided email address. They will assist you in arranging appropriate medical treatment as soon as possible.

You may have a right to take legal action to obtain compensation for injuries or complications resulting from this study. Compensation may be available if your injury or complication is caused by the interventions in this study, or by the negligence of any of the parties involved in the study. If you receive compensation that includes an amount for medical expenses, you will be required to pay for your medical treatment from those compensation payments.

If you are not eligible for compensation for your injury or complication under the law but are eligible for Medicare, you can receive medical treatment free of charge in any Australian public hospital.

10.      ‘Will I benefit from the study?’

The digital health supports in this study have previously been shown to provide benefits to patients with chronic pain reducing their opioid medications. Therefore, you may see a reduction in your symptoms and/or improvement in function and/or mood. However, we cannot guarantee this, and you may not benefit from the study. This research will also help us to better understand how digital health supports can help patients with chronic pain reduce their opioid medications and to develop programs that may improve access to treatment for people with this condition.

11.      ‘Will taking part in this study cost me anything, and will I be paid?

The digital health support will be provided to you for free. However, your participation in this study will cost you some time and energy including the time it takes to complete the study surveys and attending in an interview over the phone which, in total, will be around 75 minutes throughout the study. You will not receive payment to participate in this study.

12.      ‘How will my confidentiality be protected?’

Identifiable information (name and contact details) will be collected only if you are eligible to participate in the study. Any identifiable information that is collected about you in connection with this study will remain confidential and will be disclosed only with your permission, or except as required by law. Only the researchers named above and, if required for monitoring purposes, The Northern Sydney Local Health District Human Research Ethics Committee and regulatory bodies will have access to your information and data, which will be held securely at The Pain Management Research Institute.

We will contact you from an email address specifically used for this study (support4pain.study@sydney.edu.au). We will send text messages to your phone using a dedicated phone number used by the SMS software and over Australian telephone networks at no cost. We will use REDCap software for online surveys which will be saved on The University of Sydney server. These are automated and secure systems with protocols for encryption and authentication.

Recorded interviews will be transcribed by Rev transcription services. Rev professionals have all signed Non-Disclosure Agreements and strict confidentiality agreements, and complete transcription work on a secure platform that encrypts client files using protocols at bank-level security. The Rev Privacy Policy can be found at https://www.rev.com/about/privacy.

13.      ‘What happens with the results?’

Data collected online will be automatically saved in a database on the University of Sydney protected server. Paper documents (if any) will be scanned and uploaded into this database. Paper documents will be stored at the Pain Management Research Institute in locked cupboards. Audio files from interviews and transcripts will be saved in a password-protected computer owned by the University of Sydney to ensure data security. Data within the SMS software will be deleted after being exported at the study closure. Exported data from the database will be de-identified and stored in a password-protected computer owned by the University of Sydney to ensure data security and confidentiality. Data gathered in this study may be used by the research group of this study in future research approved by an ethics committee and such data will not contain your name or any identifiable information about you. All data will be stored for 15 years after the publication of the project’s final report and then will be securely destroyed per requirements for clinical research.

       We hope that the results of this research project will be published in scientific journals and presented at conferences and other meetings. All data that is collected in this study, including data collected by the online eligibility form from all applicants, will be saved and de-identified to remove personal information before analysis and reporting. In any publication, report, or presentation, information will be provided in such a way that you cannot be identified, except with your permission. The overall results of the study will be provided to you if you wish.

14.      ‘What happens to my treatment when the study is finished?’

After the study is finished, your care will continue as usual. You can save and access the information sent to your phone and email for as long as you wish.

15.  ‘What should I do if I want to discuss this study further before I decide?’

If you would like to know more or have questions about this study, you can contact us by email at support4pain.study@sydney.edu.au or by phone 0480490896 during office hours.

16.  ‘Who should I contact if I have concerns about the conduct of this study?’

This study has been approved by the Northern Sydney Local Health District HREC. Any person with concerns or complaints about the conduct of this study should contact 02 9926 4590 or email NSLHD-Research@health.nsw.gov.au and quote HREC reference [2022/ETH01795 and 2022/STE02938].