DYNAMIC-AI study

We are running the DYNAMIC-AI study to find out if computer-based problem solving, or artificial intelligence (AI), can help us improve care for patients with COPD. We hope that this study will help us to better treat and understand COPD in the future. By joining the study, you will be helping us to improve our understanding of COPD which will allow us to develop better treatments in the future. This may also help your own COPD care.

We are running this study to find out if computer-based problem solving, or artificial intelligence (AI), can help us care for people with COPD. These computer systems will use health information to detect health patterns and make predictions.

The purpose of this study is to:

• Establish the feasibility of using AI in a healthcare environment - does this technology work as expected in live clinical systems?
• Establish acceptability of using AI - how many invited patients consent to participate in the study?
• Establish the safety of using AI - does the technology cause any unexpected issues?
• Find out if we can use AI to identify possible changes in the health of people with COPD.

We collect a lot of health information in electronic health records and through the COPD app, and it can be difficult and time consuming to analyse it all. AI can sort through this information quickly and accurately, and to highlight things about a patient’s health that the clinicians may not spot themselves. The AI computer system then passes this information onto the medical team for decision making. This means the clinicians can process information more quickly and accurately, whilst getting more time to spend with their patients. The AI computer system will not be responsible for making any decisions about patient care by itself.

The research team consists of Dr Chris Carlin, Consultant Respiratory Physician at the Queen Elizabeth University Hospital (QEUH) in NHS Greater Glasgow and Clyde (NHS GG&C), who will be the chief investigator for the study. The study co-investigator is Dr Anna Taylor, Clinical Research Fellow, NHSGG&C. Other members of the research team include colleagues in respiratory, intensive care and emergency medicine at NHS GG&C. Independent statistical analysis of the study data will be undertaken by the Robertson Centre for Biostatistics at the University of Glasgow.

The study is funded by the NHS Accelerated Access Collaborative, which supports the development and evaluation of new technologies for healthcare. The study is being undertaken by a consortium comprising the NHS Greater Glasgow and Clyde research team, Lenus Health Ltd and StormID.

You have been invited to join this study because you have a diagnosis of COPD and have been using the COPD support service app.

No. Participation is voluntary and you do not have to take part in this study. If you choose not to join, it will not have any impact on the quality of your care and you will still be able to use the COPD digital support service.

If you would like to participate in the study, you will be asked to provide your consent electronically via the COPD digital support service app. You will be sent an email with a copy of your consent and confirmation that you are taking part in the DYNAMIC-AI study.

You will be free to withdraw from this study at any point, without giving a reason. If you withdraw, we will not collect any more of your information. We will keep information you have already provided so we can make sure the study is running safely and transparently. If you wish to withdraw consent, please contact us through the COPD digital support service app or using the contact details provided below.

We will be recruiting patients to the study from April 2023 - January 2024. We need to connect all of your health information for the AI models to work. This will help our AI models to improve over time.

When you join the study, we will access information from:

• Your healthcare records
• Your daily COPD questions from the COPD digital support service app
• Your Fitbit, if you have one
• our non-invasive ventilation machine (ResMed), if you have one

If you agree to participate in this study, there is nothing further you are required to do. You can continue to use the COPD digital support service as normal.

The insights/highlights generated by the AI computer system about your health and COPD will be reviewed by the research team. We would contact you about these insights if they suggest that you might benefit from a check-in with the clinical team, review of your self-management plan or changes to your COPD care.

Your personal and identifying information will be secure and kept private. All the information we collect as part of this study will be stored electronically by NHS Greater Glasgow & Clyde (NHS GG&C). Only the research team in NHS GG&C will have access to your personal and identifying information. Non-identifiable data collected as part of the study may be accessed by commercial partners at Lenus Health Ltd and Storm ID or regulatory bodies who are making sure the study is being conducted correctly. Non-identifiable data from this study will be analysed by the Robertson Centre for Biostatistics at the University of Glasgow as part of the evaluations of the study results. Commercial partners, the regulatory bodies and the Robertson Centre for Biostatistics will not have access to any information that may identify you.

We will document your involvement in this study in your electronic health record so that the information is available to any other clinicians who are involved in your care. We will also let your GP know that you are taking part in the study.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally identifiable information possible.

You can find out more about how we use your information at:

• NHS Inform

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Our Data Protection Officer can be contacted using the following details:

Stewart Whyte (Information Governance Manager)

Email: Stewart.Whyte@ggc.scot.nhs.uk  or Tel. 0141 355 2020

Contributing to this study may provide us with valuable information that we hope will help improve the care of people with COPD and give us a better understanding of how AI can be used in healthcare. We cannot be certain of this until we have completed the study.

Other benefits of the study may also include:

• Academic benefits to the research team
• Commercial benefits for our partners in this study. Some of these benefits will return to NHS Scotland.

If the AI model provides an indication that you are at risk for a COPD-related event, we might contact you to review the management of your COPD, or send you a check in message.

There are no anticipated personal risks involved in you joining this study.

You can withdraw from the study at any time. Your standard care will not be compromised by participating in this study, and the study won’t require any additional hospital attendances.

The study will run until January 2025. Once the study ends, we may continue using parts of the AI system. The core COPD digital support service (including patient app) will continue. We will write to all participants at the end of the study to explain whether the AI insights part of the service is continuing as routine clinical care or being discontinued.

When we have finished the study, we will store the information we have collected in the NHS GG&C SafeHaven secure research database. This means it will be available to be used in future research. You will not be identifiable from this information.

We may use data for scientific and academic publications. All published data will be anonymised. We will provide a summary of the trial results to all participants. If you would like to know more about the results and reports from the study, please contact Dr Carlin (See contact details below).

We will complete study reports to the Research Ethics Committee and publish our study findings for other researchers to use. We may publish information during the study.

The results of the study may also benefit our project partners Lenus Health Ltd and Storm ID.

This study has been reviewed by the NHS National Research Ethics Service and the Medicines and Healthcare Products Regulatory Agency (MHRA)

NHS Greater Glasgow and Clyde is the sponsor for this study based in the United Kingdom. It acts as data controller for this study. This means that they are responsible for looking after your information and using it properly. NHS Greater Glasgow and Clyde will keep identifiable information about you indefinitely (as part of your electronic health record, and within NHS SafeHaven).

Technical problems with the COPD digital support service app or electronic consent flow can be passed on via the messaging facility in the app or by emailing the COPD support team on copd.support@ggc.scot.nhs.uk. Alternatively, you can contact us via the respiratory nurse specialist team, or Dr Carlin directly, as below.

If you have questions or concerns about this project that you’d wish to discuss with an independent clinician, please contact
Dr Gordon MacGregor,
Consultant Respiratory Physician
Queen Elizabeth University Hospital,
telephone: 0141 451 6092.

In the event of any complaint arising from the conduct of this study, you can discuss this with the clinical team, or with NHS GG&C complaints department
Phone: 0141 201 4500,
email: complaints@ggc.scot.nhs.uk,
webpage: https://www.nhsggc.org.uk/get-in-touch-get-involved/complaints/

COPD support service:

copd.support@ggc.scot.nhs.uk
Respiratory Nurse Specialists:
Queen Elizabeth University Hospital
Tel – 0141 451 6073

Chief Investigator

Dr Chris Carlin
Consultant Physician
Department of Respiratory Medicine
Queen Elizabeth University Hospital
1345 Govan Road
Glasgow G51 4TF
Tel - 0141 451 6088