Insights from the NHS: the adoption of self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor) for atrial fibrillation and heart valve disease

This case study has been adapted from the adoption resource for the NICE diagnostics guidance on ‘Atrial fibrillation and heart valve disease: self‑monitoring coagulation status using point‑of‑care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor)’ and reflects the service at the time of resource publication (February 2015)

Aim: Use telehealth projects to address capacity issues across the trust

Objectives:

• International normalised ratio (INR) self-testing to be the first clinical pathway to be automated and digitised
• Improve patients lifestyle outcomes
• Improve the patients’ time in therapeutic range
• Increase time spent with more complex patients through effective digital triage

A draft care pathway for the INR self-testing service, including the protocol for patient selection and training and the specification for the Health Call INR service, was developed by the clinicians working in the anticoagulation clinic and the chief pharmacist. This ensured engagement with key stakeholders from the beginning of the project.

Criteria for inclusion are:

• Stable INR.
• Over the age of 18 years who are deemed suitable to use the service by their GP or anticoagulation nurse.
• Able to give consent and willing to participate.
• Able to understand the concept of oral anticoagulation treatment and the potential risks associated with the treatment.
• Dexterity and acuity of vision to enable them (or their carer) to use the device and telephone.
• On long-term anticoagulation therapy and requiring regular check of INR.

Once an individual has successfully completed training they filled in a registration form. On this form they indicated their preferred time for getting the 2 automated phone calls. Calls were only made Monday to Thursday, which enabled clinic staff to chase up people on Friday who hadn’t responded to the automated service. All people were given a record pad for their INR results and dose adjustments.

During this pilot phase, feedback was gathered from all participants to understand their issues and find out what was needed to design the service to meet their needs. Some changes were made to the instructions they were given during the calls and the initial sessions were reduced to 5 people to ensure more one-to-one support. A third session was also offered to people who needed extra reassurance.

Call 1:

• On the agreed day of the INR test the individual measures their INR using the CoaguChek XS meter.
• At their preferred time they receive an automated call on their nominated UK mobile or landline number and are asked to enter their INR reading, current warfarin dose, and have to answer 3 questions around bleeding and medication.
• The INR results, and any clinical alerts generated by their responses, are sent to the warfarin clinic through the automated portal.
• Using anticoagulation software and clinical judgement, their warfarin dose and date of next INR test is determined.
• The dosing regime and date of next INR test is then entered into the portal by the member of staff.

Call 2:

• The person then receives another automated call which instructs them on their warfarin dose and the date of their next INR test.

For the implementation pilot phase, 100 CoaguChek XS meters were bought. Initially participation from people who were house-bound was sought, as home testing is the most costly element of the overall service. However, few people wanted to take this up, generally because they valued the contact from their district nursing team.

Anticoagulation clinic team members were then asked to identify people attending clinic-based services who they thought would be interested and fulfilled the criteria for inclusion.

Within 3 months 100 people had been recruited to participate in the pilot. During this recruitment phase the anticoagulation lead nurse and Care Closer to Home Manager worked with Roche to develop a training package for patients. The training was delivered on a phased basis over a 3‑month period from April 2013.

The first session, delivered to up to 10 people, was designed to cover correct use of the meter and to make sure people could get an adequate ('ladybird' size) drop of blood. Everyone was then issued with a meter and asked to practice self-testing once a day at home for 1 week.

In a second one-to-one (15 minute) training session a week later, the readings on the device were checked and the person was asked to give feedback on how they had managed and if they wanted to continue with the service. If they did, their mobile phone was checked for compatibility and they were then given training on answering the automated telephone calls and understanding the process. This session included test calls to ensure people could follow the instructions.

Staff confidence in the system grew as it became evident that time in therapeutic range results for people in the pilot were at least as good, and in most cases improved, compared with those measured prior to self-testing, with an average 20% improvement for 70% of those involved.

It was decided to expand the service to another 100 people and a Trust procedure document was approved by the Clinical Standards & Therapeutic Committee in February 2014.

For the second cohort posters and leaflets were displayed in out-patient and community anticoagulation clinics inviting people to apply to become self-testing. People who applied were often working and trying to fit clinic appointments around work. Training sessions were organised flexibly in the evenings in order to accommodate their needs. The same training package and support was provided and after 6 months the time in therapeutic range for both cohorts was reviewed. 

Service user feedback was extremely positive with comments typically being around:

• Reduced time attending clinics
• Less impact on work disruption and money lost from taking holiday or no pay to attend clinic
• Money saved from travel costs and parking
• Ability to test whilst working away from home or on holiday
• Flexibility

Table 1: Time in therapeutic range (TTR) results pre- and post-implementation of self-testing

The drop-out rate was relatively low (17 people: 2 moved area, 4 died (due to non-related reasons), 5 had difficulty due to frailty, 5 stopped warfarin treatment, 1 returned to clinic).

Costs results

The business manager responsible for the service presented a cost report to the NHS trust board in May 2014 examining the financial implications of introducing an INR telehealth service in Durham and Darlington with a view to expanding the service on a sustainable basis. The key findings were:

• The INR telehealth service can be cost neutral from the perspective of variable NHS costs per person compared to the INR outpatient clinic when the savings from the reduction of strokes and other thromboembolic events for self-monitoring is taken into account.
• For the existing service models, estimated variable INR monitoring costs per person are lowest for the INR outpatient clinic at £152 per year compared to satellite clinics (£190) or home care (£333).
• Costs for the INR telehealth service are estimated at £146 per person per year for the current cohort of 200 people where the meters are already funded separately.
• Costs for fully funded INR telehealth services are estimated at £210 per person, per year. 

People who are self-monitoring are now asked to return to the clinic every 6 months for a quality control check of their meter and observation of technique. Once they are proficient, it is intended to move this to a yearly check if their INR remains stable. The average anticoagulation clinic attendance in the Trust is 18 times per year, saving 16 out-patient appointments per year, per patient. People can still contact the clinic Monday to Friday during working hours for additional support and advice if they need to.

A paper was submitted to the Trust Board outlining the case for INR self-monitoring.

This is summarised below: 

Operational: it increases capacity of existing clinics

i) Include the anticipated costs of extra clinics needed to address growing need

ii) Proposed integration with dosing software to reduce clinician time needed per telehealth patient and reduce transcribing error risk

Clinical: it improves clinical outcomes

Self-testing has improved time in therapeutic range by 20% for 70% of patients

Financial: it is cost neutral when all CCG costs are included

i) Include savings from the known reduction in adverse events

ii) Avoid large capital spend by using a rental scheme for meters

iii) Focus on the 20% of warfarin patients whose monitoring is the most expensive (that is, people who are house-bound and those who attend satellite clinics)

Strategic: it supports Department of Health and NHS England objectives

i) Improves quality of life for people with long-term conditions

ii) Patient satisfaction for INR self-testing is close to 100%

Three years on from the original pilot scheme the patients on both the original cohorts have increased their TTR by a further 1% making this a staggering 16.5% increase across the group. County Durham and Darlington NHS Foundation Trust have adopted this a core offering for Warfarin Management.

The integration with Instar and DAWN dosing systems in now complete and it has been adopted in Wigan and the Isle of Wight.