Evaluation of impact of digital scribe technology on general practitioner time use

• If your practice is in the intervention group, you will be asked to start using digital scribe technology (called Heidi) to support your work. We would like to understand your experience of how a digital scribe impacts the workflow of practice sessions and the amount of time spent on clinical documentation. We would collect data for two separate clinical sessions on two separate days, once before you start using the technology and again a minimum of 4 weeks after you have started using the digital scribe technology.
• If your practice is in the control group, we would like to study the amount of time you spend on clinical documentation. We would collect data for two separate clinical sessions on separate days, approximately 6-8 weeks apart from each other.
• For both groups, we ask you to consider being observed in the two clinical sessions by a researcher who will record your activities during the session. They will not record any patient information involved. If your practice is in the intervention group, we would like to conduct a brief (10 minute) interview at the end of the second observation session. Optionally, you may also provide a self-report log of current activity for several time points.
• Your practice will be compensated for your time.
• Please read this information sheet before deciding whether to express interest in participating in the study.
• If you have any questions or would like more information, please contact the study team via email: digitalscribe@thisinstitute.cam.ac.uk.

• A digital scribe converts the conversation that takes places during a medical consultation into text and provides a written summary of the consultation. Digital scribes are already being used in different parts of the NHS, but there is limited understanding of the impact of digital scribes on clinician time and the quality of clinical documentation.
• This project aims to understand the impacts of a digital scribe on primary care GP’s time, by evaluating if and how a digital scribe changes the amount of time staff spend on clinical documentation.
• This project also aims to learn more about the impact of digital scribes on patient experience.
• The findings of these interviews will help to develop an understanding of how a digital scribe can be implemented in practice.
• This project is being led by researchers at The Healthcare Improvement Studies (THIS) Institute based at the University of Cambridge, working in partnership with The Health Foundation.

• You have been given this participant information sheet about taking part in this study because your organisation is planning to implement a digital scribe or has agreed to participate in the study as a control practice.
• Taking part in any or all the study components is entirely voluntary. Deciding not to take part or withdrawing will involve no penalty or loss, now or in the future. You can withdraw your participation at any time.

• If you would like to take part, please review the details on this project page and then click “take part” to complete a consent form.

Consultation observations (control and intervention groups)

• You will be observed for two in-person clinical sessions (including time for working on documentation before and after seeing patients) by a researcher. A clinical session may last up to 6.5 hours, including tasks undertaken before or after seeing patients.
• The researcher’s focus in the observation is your time spent on clinical documentation, including how and when you complete clinical documentation during and after consultations. The study is not concerned with the content of consultations or any patient data.
• The researcher will be using a handheld device to track time spent on different tasks and will make field notes about your working context (e.g. the technology you are using) but will not record any patient-related or personally identifiable data.
• Patients will be informed that observations are taking place when they sign in at reception. We ask that you seek verbal consent from each patient whose consultation will be observed and suggest the following phrasing:
  • “I am being observed today for a research study on technology – the researcher will not focus on you or your care or have any access to any of your details. The project will not interfere with the care you receive. If you would prefer them not to be in the room, that is completely okay – we can ask them to step out."
• The researcher will leave the room if the patient does not or cannot give consent to being observed, or you judge that it is not appropriate for the observer to be present.
• If your practice is in the intervention group, you will be asked for a short interview lasting about 10 minutes immediately after the clinical session ends to ask for your feedback on using the digital scribe during that session. It will be recorded on an encrypted dictaphone and fully anonymised afterwards when it is transcribed. The audio file will be deleted.
• The measures we will record include time spent on typing a consultation summary (without the use of a digital scribe), time spent on editing and reviewing digital scribe output, and time spent on digital interactions for other clinical tasks (e.g. writing prescriptions, reading patient history).

Follow-up interview (Intervention group only)

• You may be invited for a longer follow-up interview about your experience of using a digital scribe in consultations and to aid with completing clinical documentation.
• If you agree to take part in a follow-up interview, the study team will contact you to arrange a time for a remote interview via telephone or videocall.
• The follow-up interview will take a maximum of 45 minutes. If conducted via telephone, the follow-up interview will be recorded on an encrypted dictaphone, that only the research team have access to. If conducted via Microsoft Teams, the interview will be recorded and saved in a SharePoint/OneDrive file then transferred to a secure University of Cambridge Safe Haven that only the research team have access to.
• Interviews will be transcribed, anonymised and the audio file deleted when the study concludes. Anonymised transcripts will be transferred to the University of Cambridge Safe Haven and retained for up to ten years after the study has ended (defined as the end of data collection).

Consultation duration (export from electronic health record)

• At the end of the study (after the second visit to your practice), we would like to export data on consultation duration, if your EHR system supports this. This data does not include any patient details, only a summary of consultation duration. We will seek support from your practice to do this (you will not need to complete the export).

Self-report log (control and intervention groups)

• You may be asked to complete an optional self-report log of your time spent on clinical documentation and other activities, recorded using an application on your smartphone or mobile device.
• Examples of clinical documentation include patient notes/summaries, letters, image requests, and orders.

What are the benefits of taking part?

• Your input in this study is important; it will help our understanding of the impact of digital scribe technology on general practitioners’ time use.
• The results of this study may inform national guidance on the use of digital scribes in primary care. It is important that such guidance becomes available and that it is evidence-based.
• Taking part will give you the opportunity to share your expertise and experiences.
• Your practice will be compensated for the time spent engaging in our research.
• We hope the project will improve healthcare for staff, patients and people supporting patients in the future.

What are the risks of taking part?

• There are no known risks associated with participation.
• If you change your mind about taking part in the study, you can withdraw at any time without giving a reason. However, it may not be possible to remove research data that has already been analysed. To withdraw please email digitalscribe@thisinstitute.cam.ac.uk.
• We appreciate that it may be difficult to find the time to take part in the study. For follow-up interviews, we will provide flexible dates and times.
• In the unlikely event that you incur harm as a result of taking part in this research, you may be entitled to compensation through University of Cambridge public liability insurance.

• We will need to use information from you for this research project.
• This information will include your name, contact details, practice name, and your contract type (partner/salaried/other). People will use this information to do the research or to check your records to make sure that the research is being done properly.
• People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.
• The University of Cambridge is the sponsor for this study based in the United Kingdom.
• The University of Cambridge is responsible for looking after your information. We will share your information related to this research project with the following types of organisations:
  • Interview recordings will be transcribed by a professional transcription company, 1st Class Secretarial.
  • Other academic organisations.
  • THIS Labs is a research organisation that oversees the Thiscovery platform.

• We will keep all information about you safe and secure by:
  • The information linking your name and code number will be stored on the University of Cambridge Safe Haven. This information containing the link is only accessible to the research team.
  • If conducted via telephone, the interview will be recorded using an encrypted dictaphone and transferred to a secure University of Cambridge Safe Haven that only the research team have access to.
  • If you participate in a short interview immediately after the clinical session ends, this will be recorded using an encrypted dictaphone. The recording will be stored on a secure University of Cambridge Safe Haven that only the research team have access to. The same applies to follow-up interviews conducted via telephone or videocall.
  • If your follow-up interview is conducted via Microsoft Teams, the interview will be recorded and saved in a secure SharePoint/ OneDrive file, then transferred to a secure University of Cambridge Safe Haven that only the research team have access to. Once the transfer is complete, the SharePoint/ OneDrive file will be deleted.
  • Any identifiable information held about you is stored in a secure area in locked filing cabinets at the University. Electronic identifiable data will either be stored on NHS computers or in the University Secure Research Computing Platform (SRCP) which has additional security measures in place to protect your data.

• We may share or provide access to data about you outside the UK to enable the functioning of the Thiscovery platform, which uses trusted global third-party services as part of their technical set-up. This means your personal information (such as your name, email address, and responses) may be processed on secure systems outside the UK.
• If this happens, we will only share the data that is needed.
• If your data is shared outside the UK, it will be with the following sorts of organisations:
  • Third-party service providers like Voxco, Google Analytics, Amazon Web Services, and SendGrid, who provide their technical services to the Thiscovery platform.
• We will make sure your data is protected. Anyone who accesses your data outside the UK must do what we tell them so that your data has a similar level of protection as it does under UK law. We will make sure your data is safe outside the UK by doing the following:
  • the countries your data will be shared with have an adequacy decision in place. This means that we know their laws offer a similar level of protection to data protection laws in the UK.
  • we need other organisations to have appropriate security measures to protect your data which are consistent with the data security and confidentiality obligations we have. This includes having appropriate measures to protect your data against accidental loss and unauthorised access, use, changes or sharing.

• Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
• We will keep your study data for a maximum of two years. The study data will then be fully anonymised and securely archived or destroyed.

• You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
• You have the right to ask us to access, remove, change or delete data we hold about you for the purposes of the study. You can also object to our processing of your data. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.

Where can you find out more about how your information is used?

• You can find out more about how we use your information: https://www.information-compliance.admin.cam.ac.uk/data-protection/research-participant-data.
• By emailing the research team at digitalscribe@thisinstitute.cam.ac.uk.
• Thiscovery (www.thiscovery.org) is a secure online engagement, consultation and research platform that makes it possible for more people to get involved in innovation and improvement to support better health and care in the UK. Thiscovery will ask for basic information about you and your job role as part of the eligibility check and signing the consent form, which will be stored in the Thiscovery database for the duration of the study and will not be kept longer than is necessary for the purpose for which they were collected. For more information on how Thiscovery manage data, see: https://www.thiscovery.org/privacy-policy.

• Your contributions will be analysed along with the contributions from other participants. Findings from the project will be published, for example in reports or academic journals, and may be publicised on social media.
• If you would like to be updated about outputs from the project, THIS Institute will keep your contact details for this purpose only. THIS Institute will store your name and email address on the ‘HubSpot’ platform, a secure customer relationship management (CRM) database. THIS Institute will only contact you to provide a summary of results of the study. Your contact details will be kept for as long as the project is ongoing and then deleted. You can also ask us to delete them before that time.

• The project is organised by an independent and highly experienced team from the University of Cambridge, led by Professor Niels Peek from THIS Institute, University of Cambridge.
• This project is funded by The Health Foundation, an independent charity committed to bringing about better health and healthcare for people in the UK.
• The project has been reviewed by the Health Research Authority (Ref: 25/YH/0078).

• For any questions or additional information, please contact the project team via email: digitalscribe@thisinstitute.cam.ac.uk.

For any complaints or concerns

• If you have a complaint about any aspect of the project, please contact the Principal Investigator, Professor Niels Peek, at niels.peek@thisinstitute.cam.ac.uk.
• If this does not resolve your complaint, please contact the head of Public Health and Primary Care at the University of Cambridge, John Danesh, at john.danesh@medschl.cam.ac.uk.
• If you wish to raise a complaint about how we have handled your information, please contact the university Data Protection Officer at dpo@admin.cam.ac.uk.
• If you are not happy with their response or believe they are processing your data in a way that is not right or lawful, you can complain to the Information Commissioners Office (ICO) at www.ico.org.uk or telephone 0303 123 1113.

Research team

• This project is being conducted by The Healthcare Improvement Studies (THIS) Institute, in a team led by:
  • Professor Niels Peek, Professor of Data Science and Healthcare Improvement at THIS Institute.
  • Professor Mary Dixon-Woods, Health Foundation Professor of Healthcare Improvement Studies and Director at THIS Institute.

• THIS Institute is an organisation that develops evidence for healthcare improvement alongside people whose expertise is grounded in lived experience. You can find out more about THIS Institute on their website.