How can commissioners maintain oversight of patients post referral? East Surrey’s inflammatory bowel disease pathway provides one example
How can commissioners maintain oversight of patients post referral? East Surrey’s inflammatory bowel disease pathway provides one example
As GPs we have the cradle to grave responsibility for our patients on the registered list. We cannot discharge them, they remain our responsibility even when we refer them on to another colleague. We need to be confident that their safety and care are never compromised once someone else is treating them. In the East Surrey Clinical Commissioning Group (CCG) it was felt there was a better way of ensuring patient safety and quality of care could be improved.
The treatment of inflammatory bowel diseases had changed and we wanted to ensure that our patients were treated as rapidly and safely as possible with the new regime. We developed a new pathway in conjunction with our secondary care colleagues and devised a locally commissioned service (LCS) to enable all GPs to take part.
Ulcerative colitis (UC) and Crohn’s disease (CD) are the two major forms of inflammatory bowel disease (IBD) and have a prevalence of approximately 400 patients per 100,000 population. IBD has a peak incidence in the late teens/early twenties, a second peak in the mid-fifties and is uncommon after the age of 65 (20%). The annual incidence of UC is 24.3 per 100,000 person years. The annual incidence of CD is 12.7 per 100,000 person years. The current local inflammatory bowel service has been reshaped from an inpatient dominant model to an outpatient dominant model with a successful focus on immunomodulator therapy for patients with more severe disease. Significant progress over the last four years has increased the number of patients on azathioprine locally from 200 to 470.
The current inflammatory bowel model involves patients attending hospital outpatient clinics frequently to obtain: blood tests, azathioprine prescriptions and specialist advice. The specialist advice component is squeezed by the service requirement for prescriptions and blood test forms. Travel to the hospital and waiting in an over capacity outpatient clinic is time expensive. Some patients who may benefit from the specialist service and disease modifying therapy currently do not access the service. Patients with a more severe disease, who are not treated with immunomodulator therapy, have an increase in hospital admissions and surgery; 470 patients with inflammatory bowel disease are currently treated with azathioprine/6-mercaptopurine therapy. It is anticipated that an additional 150 patients with inflammatory bowel disease may benefit from this therapy.
Aims and objectives of service
To support the maintenance of immunomodulator therapy for patients with IBD. The disease remission is associated with an improved quality of life, reduced admissions and reduced need for bowel surgery.
Service description/care pathway: current guidance from the UK Inflammatory Bowel Disease Audit recommends that care for inflammatory bowel disease patients is delivered locally with rapid access for more specialised services when needed. The specialist clinician will make the primary diagnosis of IBD. The IBD gastroenterologist will request a thiopurine methyltransferase (TPMT) assay. TPMT is an enzyme that deactivates 6-mercaptopurine. The thiopurine methyltransferase level is checked, by the IBD gastroenterologist, before starting azathioprine or 6-mercaptopurine. Patients deficient in thiopurine methyltransferase are at an increased risk of bone marrow suppression if treated with azathioprine or 6-mercaptopurine. The initial treatment to induce remission will be recommended, and provided, by the specialist IBD clinician for three months. The prescribing and blood test reviews will be referred back to the GP, after achieving a stable immunomodulator therapy with allopurinol and either azathioprine or 6-mercaptopurine at three months. There are three advantages of combining azathioprine with allopurinol:
1. Reduction in treatment limiting side effects of AZA/6MP: gastric intolerance (pain, nausea and vomiting), hepatotoxicity and flu like symptoms. This allows more IBD patients to tolerate immunomodulator therapy.
2. Gain response in 70-80% of patients of AZA/6MP non-responders.
3. Reduction in use of biological therapy. The GP will check the patients’ full
blood count, urea and electrolytes and
liver function tests once every three months.
Patient
The IBD gastroenterologist will explain to the patient the risks, benefits and patient responsibilities of attending for regular blood tests while prescribed azathioprine/6-mercaptopurine and allopurinol. The clinic will send a letter to the patient. It will detail:
- The diagnosis, azathioprine/6-mercaptopurine and allopurinol dose.
- The azathioprine potential side effects, side effect recognition and appropriate management.
- The frequency and blood tests required will be detailed.
- Side effects: azathioprine side effects occur in up to 40% of patients and include; gastric intolerance (up to 16%), allergic reactions (fever, rash and arthritis) in 2.3% of patients, leucopenia due to bone marrow suppression (1.4%), and pancreatitis (1.4%) (the literature suggests that there is a three to four times increased risk of developing lymphoma in patients taking azathioprine).
Monitoring
The initial three months monitoring will be the responsibility of the inflammatory bowel disease team. Once the patient’s medication is established, after at least three months of therapy, the general practice team will consider taking on responsibility for monitoring the blood tests every three months.
Baseline
In order to keep patients safe it is important to test and measure their bloods to monitor the effect of the drugs.
- Check full blood count, urea and electrolytes and liver function chemistry.
- Check the full blood count every week for six weeks then monthly for three months to be done by inflmatory bowel disease team, then the GP takes over responsibility to check full blood count urea and electrolytes and liver chemistry every three months. Only need to check serum amylase in the context of abdominal pain.
The initial azathioprine myelosuppression risk peaks at six weeks with a trend reduction in neutrophil and lymphocyte count in the preceding weeks.
The strategy to monitor and act is as follows:
- If the white cell count is at 4 x10^l then no action needed.
- If it is between 3-4 x10^l, monitor weekly and if no progressive fall no action needed.
- If it falls to between 2-3 x10^l then half the azathioprine dose if the patient is well. Stop it if the patient is unwell.
- If the white cell count falls below 2×10^l then immediately stop the azathioprine and monitor weekly until the white cell count rises above 4×10^l and contact the IBD gastroenterologist.
- If the white cell count falls below 1×10^l stop drug and admit for haematological assessment.
- If the liver function tests aspartate transaminase or alanine transaminase rises to twice the upper limit of normal then contact the IBD team.
- If it rises to four times the upper limit of normal stop the treatment and contact the team.
Outcomes
In order to comply with the quality requirements of the scheme the following apply for each participant.
The outcomes will be measured and judged as a success when the proportion of people feeling supported to manage their condition rises. There will be an increase in the employment of people with these long-term conditions. The GP and patient will be jointly engaged in monitoring and proactively managing the disease. The safety of patients on immunomodulator therapy requires consistent blood monitoring to ensure safe prescribing, and the GP who signs the prescription must be happy that those tests are done and are in the right range before signing.
Quality requirements that are applied to the scheme
For the patients
- Improved uptake of immunomodulator therapy, to limit IBD progression and active disease, is associated with an improved quality of life, reduced admissions to hospital and reduced need for surgery.
- Timely access to gastroenterologist for initial diagnosis, early initiation of therapy and management of exacerbations.
- Local access at GP surgery for medication and regular blood tests.
- Reduction in time and travelling to hospital out patient clinics.
Gastroenterologist
Resource directed to patients with more severe disease or acute exacerbations. Improved capacity to extend immunomodulator therapy.
For the CCG
- Extending immunomodulator therapy reduces the demand for hospital admissions and bowel surgery.
- Early referral: GPs should refer patients with possible IBD within six weeks.
- Early assessment: gastroenterologists should assess possible IBD patients within four weeks.
- Steroid free remission proportion of patients in remission not requiring steroids.
- IBD hospital admission: reduction in IBD related hospital admissions.
- IBD surgery: reduction in IBD related surgery.
- The outcomes that the scheme will be judged on to improve
- patient care:
- The proportion of people feeling supported to manage their condition.
- Employment of people with long-term conditions.
- GP and patient engagement.
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Active management and review of patients on immunomodulator therapy requires consistent blood monitoring to ensure safe prescribing.
By working as a team patients are seen in the right place at the right time by the right person. Blood tests are taken in surgeries and checked by the requesting physician to ensure they don’t fall into a black hole of outpatient results. GPs feel more empowered to treat conditions traditionally in secondary care based settings and most importantly patients have much better outcomes.
The lessons learnt with this project will enable more care to be delivered closer to home as the traditional expensive hospital based option becomes redundant. With the advent of near patient testing and telehealth and telemedicine and patient empowerment to self-monitor, the way medicine is delivered will be truly modernised.
Resources
Applicable national standards (eg NICE)
guidance.nice.org.uk/CG166/NICEGuidance/pdf/English
guidance.nice.org.uk/CG152/NICEGuidance/pdf/English
www.rcplondon.ac.uk/projects/inflammatory-bowel-disease-audit
Dr Joe McGilligan is former chair, NHS East Surry CCG (ESyDoc) and chair of The Commissioning Review editorial board.
