Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system)

Tottington and Greenmount Medical Practices, Bury

Tottington Medical Practice is the largest GP practice in the Bury clinical commissioning group (CCG) area with a practice population of 12,323 and 8 GPs. Greenmount Medical Centre has a practice population of 9309 and 6 GPs. Nurse-led anticoagulation clinic services have been provided by both practices for a number of years.

Since August 2010, both practices have provided a 'stable patient' anticoagulation service through a local enhanced service agreement with Bury CCG. The service involves near-patient testing using finger-prick blood testing.

The lead GP for the anticoagulation service in the Tottington practice wanted to make it more efficient, with quicker results and less disruption for users. Even though practice-based clinic appointments tended to be quicker than hospital-based ones, people still had to make the appointments, take time to attend and wait for their international normalised ratio (INR) results. Two patients in the practice had self-funded CoaguChek XS meters as they had found it difficult to attend the practice for INR testing due to the nature of their jobs. They were supported by the practice nurse and GP in this decision. Both patients had gone on to improve the INR time in therapeutic range following self-testing. This prompted the lead GP to explore the development of a self-monitoring anticoagulation service.

A Programme Manager in the CCG Public Health Team worked with the lead GP from the Tottington practice to develop an application for funding from the CCG Innovation Fund for a pilot period of 6 months. In order to meet the timescales required to implement the pilot and recruit 30 service users, Greenmount Medical Centre was also invited to participate. Following a successful bid, 30 CoaguChek XS meters were purchased in December 2013. Tottington practice was allocated 22 devices and 8 of these were allocated to Greenmount. A service algorithm was designed for the managing clinicians as a guide for frequency of monitoring and level of telephone support needed depending on individual INR results.

Both practices recruited 30 patients, aged 24–75 years, on the basis that their GP was confident:

The practices ran 3 education evenings in January 2014 to enable all people to attend one session. A nurse practitioner from the company provided training, delivered in a 2.5 hour-long session with support from the lead GP and practice nurse for the pilot. The focus of the training session was to assess peoples' dexterity, and their ability to perform the test and understand and comply with the proposed regimes. Everyone started self-testing in the first instance to gain self-confidence in doing the test and to give them and the practice staff confidence in the self-monitoring service. Everyone was given a named contact in their practice for queries or concerns. At the end of the session, each person was provided with a meter and test strips and an agreed action plan based on their individual needs and level of confidence.

People were asked to practise self-testing at home to gain confidence. They were given a specific date when the practice nurse would ring them to discuss their progress and any health-related issues, who would then enter their INR result into anticoagulation software for dosing and review period suggestions. Another telephone appointment was then made, dependent on the result, for the next test. People were encouraged to monitor their INR between these appointments if they had any concerns or changes to other medication, and to phone the practice if their INR results were not within their target range.

Within 3 months, 27 people were successfully self-monitoring and continued to do so. During the course of the pilot, 3 people moved away. Of those continuing to self-monitor, 8 have a diagnosis of atrial fibrillation; 7 have recurrent deep vein thrombosis; 5 have antiphospholipid syndrome; 4 have pulmonary embolism; and 3 have heart valve disease.

Telephone contacts from people requiring support and advice reduced after this period. In line with quality assurance measures, everyone was asked to visit their practice after 3 months, to perform a CoaguChek test at the same time as the practice undertook a venous test. All readings from the self-testing devices in the previous period were recorded on the practices' anticoagulation data record. This quality assurance is intended to continue on a twice-yearly basis.

The pilot has been evaluated positively by all the service users involved and was considered to be a success by the clinicians supporting the service. The average time in therapeutic range for people self-monitoring in the Tottington practice improved from 64% to 71%, and in the Greenmount practice from 55% to 63%. There have been no emergency department attendances related to anticoagulation and no serious adverse events reported.

One person was supported to move to self-management to support their personal choice. They had additional training from the practice nurse on understanding the dosage algorithm. Initially, they followed the same procedure as for self-testing and rang their practice nurse with their INR result. The practice nurse would then enter this into the anticoagulation software and ask them, based on their result, what they would do in terms of dosing and next test based on their dosage sheet. This gave both the individual and the practice staff confidence in progressing to self-management. The practices are now planning to offer other people who are self-testing the opportunity to progress to self-management, for whom this would be a preferred option.

The CCG local enhanced service agreement for practices providing a 'stable patient' anticoagulation dosage and monitoring service, allows for up to 10 visits to the practice per year, up to a maximum cost of £200 per patient. While both practices would like to extend the opportunity to self-monitor to other people, at this time there is no financial model to support this due to the high initial investment which was supported by innovation funding for the pilot. Any future agreement, whether local enhanced service or any qualified provider, for people supported to self-monitor would need to take these up-front costs into account.

County Durham and Darlington NHS Foundation Trust

County Durham and Darlington NHS Foundation Trust is one of the largest integrated acute and community services providers in England. 8000 staff serve a population of around 600,000 across County Durham, Darlington, North Yorkshire, the Tees Valley and South Tyneside. Acute hospital services are provided from 3 main sites.

The NHS trust is commissioned by local CCGs to provide anticoagulation services under an 'any qualified provider' tariff. There are 2648 people who take warfarin, who are supported by the trust in a number of locations including hospital outpatient clinics, community satellite clinics and in people's homes.

In 2012, the Clinical Director for Adult Nursing led a successful bid for regional innovation funding for a number of telehealth projects to address capacity issues across the trust. The trust wanted to provide services which could use an automated phone system to help deliver care and ensure an audit trail. Working in partnership with Inhealthcare Ltd, the 'Health Call' digital healthcare service was developed.

The first clinical pathways to be automated and digitised included international normalised ratio (INR) self-testing. Project management within the trust was provided by the Care Closer to Home Programme Manager for Telehealth, working with the Business Development Manager.

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 together with the clinicians working in the anticoagulation clinic and the chief pharmacist. This ensured engagement with key stakeholders from the beginning of the project.

For the implementation pilot phase, 100 CoaguChek XS meters were bought. The initial plan had been to focus the self-testing INR service on people who were house-bound, as home testing is the most costly element of the overall service. District nurses identified people who they thought could manage and offered them training and the opportunity to self-test. Very 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.

Once an individual had successfully completed training they filled in a registration form. On this form they indicated their preferred time for getting the 2 automated phone calls. To ensure that people who didn't respond to the automated service were followed-up, calls were only made Monday to Thursday, which enabled clinic staff to chase up people on Friday, if needed. All people were given a record pad for their INR results and dose adjustments.

Call 1:

Call 2:

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.

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

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.

People in the second cohort were not selected by clinic staff. 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, therefore 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. The age range in both groups was similar at 30–80 years, with most people being in their sixties or seventies. Table 1 demonstrates that the results from a self-selected group of people were as good as those from people hand-picked by staff.