Terms of Enrolment into the BEATdiabetes Programme
The aim of the BEATdiabetes Service is to provide a self-referral service to those who wish to receive online support for their diabetes. Three online tools are available which can be used either individually or in any combination.
For the purposes of this document an individual participant with type 2 diabetes who is age 18 years or older may enrol into this service and will be term the ‘User’.
The user will require access to a digital device with either internet access or access to Apps.
The user will be required to provide the following mandatory information to register on the www.beatdiabetes.org.uk site:
- First Name and Surname
- Contact Phone Number
- Date of Birth
- Name of Registered GP Practice
This information will be stored on the www.beatdiabetes.org.uk hosting server provided by Amazon Web Services (AWS) which is a secure server that meets the NHS standard for cyber and data security. The user will be assigned a unique reference number (URN) for pseudonymisation purposes.
Clinical Data Capture
The user will be sent an email following registration detailing how to book into the BEATdiabetes Clinic:
The user should book into a BEATdiabetes Clinic. There will be a link within the email received allowing the user to make an online booking into a clinic appointment of their choice. These clinics may be held at a local GP practice or local community hospital and will run several times a week. At this appointment the user will have a blood pressure, weight and height check. The healthcare assistant (HCA) working in these clinics will also record the user’s gender, ethnicity and smoking and alcohol status. The user may also have a blood test to check the HbA1c (measure of diabetes control) and cholesterol. The HCA will enter the clinical data collected into a secure EMIS electronic patient record which is secure and only accessible by health care staff contracted under Salus Medical Services.
The HCA will check the results of these blood tests on the ICE pathology software which links in with the EMIS electronic patient record. A copy of the blood results and clinical data captured will be sent to the user’s GP.
The HCA will need to record whether or not the user has any of the following conditions:
- Previous Stroke/TIA
- Congestive Cardiac Failure
- Peripheral Arterial Disease
- Renal Replacement (Dialysis)
- Renal Impairment (categorised by stage using the most recent measure of eGFR 3a, 3b, 4, 5)
- Ischaemic heart disease
The HCA may need to check the accuracy of this detail by requesting a ‘patient summary history’ from the user’s GP with prior consent from the user. A copy of the user’s signed consent form may be taken in BEATdiabetes clinic and attached to an email to the GP providing the necessary authorisation by the user to allow release of this information to the HCA.
The HCA will also record the name and dosing of the user’s current diabetic medications and the length of time that the user has had Type 2 diabetes for. The patient summary history again may be used to check for accuracy.
The user’s name, address, postcode, date of birth, gender and ethnicity will also becaptured by the HCA and entered into the secure Salus EMIS electronic patient record.The HCA is contracted under Salus Medical Services to run the BEATdiabetes Clinics. Only the HCA will have access to this level of detail. Dr. Sarah Carrod, the project lead will also be able to view this level of data to ensure quality control and accuracy of data collection and input into the BEATdiabetes portal.
The above information is important because it will be used in the evaluation part of the BEATdiabetes service and compared to other people with type 2 diabetes who have similar conditions to assess whether the BEATdiabetes Service has worked when compared to existing diabetes services.
The reason for collecting the user’s diabetic medication information is to assess whether, over time, there is a reduction in the need for diabetic medications when taking part in the BEATdiabetes Programme and whether this is sustained over the longer-term period of 12 months.
At 6 months and 12 months from first accessing the BEATdiabetes programme, the user will be required to have their clinical data measured again as detailed above. Again, this will take place by attendance at the BEATdiabetes clinic. The data will be captured in the same way as described for the baseline data capture.
At monthly intervals, data inputted into the SALUS EMIS electronic patient record with be uploaded into the secure BEATdiabetes portal. Within the portal the data will undergo electronic transmission to the North East Hants and Farnham (NEH&F) clinical commissioning group (CCG) facing side of the portal and in doing so all personal identifiable data will be extracted leaving only the URN as the identifier. In so doing all data undergoes an automated pseudonymisation process helping to protecting your identity. This means that no personal identifiable data will be passed onto any other organisation including NEHF CCG. The following personal identifiable data will be extracted:
- Full Name and contact details such as address/phone number/email address
- The last two digits of the user’s postcode
- Users will be grouped into 5 yearly age bands thus not divulging a user’s precise age
Only the URN will remain to differentiate each user. This therefore renders the data non-identifiable thus protecting the user’s personal identity.
Questionnaire Data Capture
The user will be emailed a web link which, when clicked, will take the user to a programme comprising of up to four questionnaires. The user will be asked to complete these four tick box style questionnaires, some of which include a small number of open questions. Only the user’s URN will be used as the reference in these questionnaires and no other personal or identifiable data will be used.
The 4 questionnaires are as follows:
- Diabetes Distress Questionnaire
- Work and Social Adjustment Scale
- EQ-5D-5L Questionnaire
- Friends and Family Test
The user will be sent the email link for completion of these before starting the BEATdiabetes online service (otherwise known as baseline), at 1 month, 3 months, 6 months and 12 months from first commencing the service.
The completed questionnaires will be sent through to the secure BEATdiabetes Portal (the CCG facing part of the portal) where this information will be collated with the data collated above i.e. non-personal identifiable data. These two data sets are collated using the user’s URN and no personal identifiable data. This will be an automated process.
Activity Data Collection for each online tool
In order to assess user experience and to try and understand and improve the services we offer, it is important to understand how the user utilises the three online tools. Each of the three online tool providers (SilverCloud, OurPath and Commit to Change) will therefore undertake the following analysis of each user experience:
- Total time spent using the online tool
- Number of logins/sessions
- Percentage of the programme viewed
- Number of reviews; number of times user reviews are submitted
- Journal entries and length: number of times a user enters information about mood/behaviour and amount of text they provide
- Time spent per session: length of time spent on the tool each time the user logs in.
- Tools per session: which elements of the online tool have been engaged with each time the user logs on.
- Times a tool was used.
- Messages sent: number and type of messages sent from health coach
- Use of the technology (weighing in or syncing activity tracker): number of times user transmitted weight and activity data
- Educational articles read: number and type of articles read
- Goal set (free text) e.g. no junk food for 5 days, only smoke 2 cigarettes a day
- Referee nominated to help user track goals? Yes/No
- No. of supporters the user nominates who are also emailed about progress in meeting goals (peer pressure)
- Financial pledge made? Yes/No
- Goal achieved: Yes/No. Collected automatically on a weekly basis
Some of the above will be collected for each of the three online tools. This activity data will be collated against the URN for each user to ensure identity is protected. Each online tool provider (SilverCloud, OurPath and Commit to Change) will send the respective activity data electronically to the BEATdiabetes portal to be collated with the questionnaire data and clinical data described above.
Evaluation of the BEATdiabetes Service
NEH&F CCG, having received the following three data feeds below (with URN as the only reference), will collate this into one secure spreadsheet held on the BEATdiabetes portal.
- Clinical Data Capture
- Questionnaire Data Capture
- Activity Data Collection for each online tool
NEH&F will then enable access via a secure login for the University of Surrey so that they can conduct an evaluation of the outcomes of the BEATdiabetes programme. No personally identifiable data will therefore be made available and instead only row data with reference to a URN will be visible. The HCAs undergo data protection and confidentiality training to ensure that your data is kept secure. User identify will therefore be kept secure and will not divulged to any other parties without the expressed consent of the user.
Qualitative Data Sampling
The consent form will invite the user to take part in an interview with the University of Surrey. This is optional and the user can decline this invite and this will not negatively impact on their ability to take part in the programme in any way. The interview will seek to establish an exploration into the user experience of taking part in the BEATdiabetes service. Because this involves a face to face or telephone interviews, the user’s identify cannot be kept from the evaluating team (University of Surrey). This part of the evaluation will be required expressed written consent to take part which the University of Surrey will coordinate. If the user agrees to take part in these interviews, their email contact and phone number will be made available to the University of Surrey so that they may make contact.
Destruction of Data
All clinical data is required to be held for a period of 7 years before it can be destroyed. Anything therefore collected from the user which falls within this remit (blood pressure, weight, height, blood results) will be kept for this length of time. This data will be kept secure and when this period of retention expires, the records will be destroyed by standard NHS data disposal processes.
Any data that is not clinical such as user activity data (described above) and questionnaire data will be securely destroyed as per stand NHS data disposal processes at the end of this BEATdiabetes Service (approximately 18months from the start of the BEATdiabetes programme).
Should you have any questions about any of the above, please contact the BEATdiabetes team at the following address or email contact:
Dr Sarah Carrod
North East Hampshire and Farnham CCG
Aldershot Centre for Health
1.That I have read the BEATdiabetes Participant Information Guide and Terms, have had the opportunity to consider the information, ask questions and have had these answered.
2. That my enrolment onto the BEATdiabetes programme is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected. I can do this by emailing my request to NEHFCCG.BEATdiabetes@nhs.net
3. That details of my medical history (outlined in the terms) and clinical data (blood pressure, weight, height and blood results) will be collected and viewed by the HealthCare Assistant (HCA) working for Salus Medical Services.
4. That programme activity data will be linked to the clinical data and questionnaire responses collected using a Unique Reference Number (URN). This data will only be presented in a pseudonymised format (using the URN) for evaluation purposes.
5. That the evaluation results of the BEATdiabetes service may be published in a medical journal. If you would like to receive an electronic copy of the publication, please email: NEHFCCG.BEATdiabetes@nhs.net
6. That North East Hampshire and Farnham Clinical Commissioning Group (CCG) are the data controller for the information collected and stored on the BEATdiabetes portal.
7. That the University of Surrey, Salus Medical Services, OurPath, SilverCloud and Commit to Change are the data controllers for the information they collect individually.
I Consent to:
8. My registered GP providing the HCA a copy of my medical summary history (including past medical history and current medications).
9. My GP being notified of my enrolment into the BEATdiabetes Service and that they will be provided copies of my blood test results and clinical measurements taken as part of the BEATdiabetes Test Bed.
10. The BEATdiabetes team/HCA contacting me by phone, email or address in the event that one of my measures returns an abnormal result that requires a review/follow up.