Pilot study of patient directed monitoring of Crohn’s disease using Faecal Calprotectin

Project: Pilot study of patient directed monitoring of Crohn’s disease using Faecal Calprotectin

Year: 2016 – IN PROGRESS

Researcher: Dr James Turvill, Consultant Gastroenterologist, York Teaching Hospital NHS FT

Background:

Faecal calprotectin (FC) is a biomarker of activity in Crohn’s disease, now widely used in clinical practice. It has been demonstrated that, in patients established on therapy, Crohn’s disease activity correlates logarithmically with FC levels. Furthermore, in the asymptomatic, FC has a high negative predictive value (NPV) for risk of symptomatic flare or relapse in the future [1].

Thus, a raised FC in the absence of symptomatology predicts for a flare of disease and a normal FC, in the presence of symptoms, is usually caused by a superimposed irritable bowel syndrome (IBS). The former requires early secondary care intervention and the latter, expectant care, perhaps delivered locally.

Based on this evidence, York Hospital has developed and evaluated a guideline for the use of FC in monitoring patients established on therapy for Crohn’s disease [2]. This guideline now supports the nurse led care of many of our patients.

Whilst effective, this approach to Crohn’s disease activity monitoring remains somewhat rigid and ‘top down’, being focussed more on optimising secondary care resource, such as the running of busy outpatient clinics, than on being responsive to the needs of an individual patient. Would a more flexible, patient centred approach to monitoring be better? What if patients were trained to take control of their own care pathway? Here, monitoring of Crohn’s disease activity would continue safely but also to allow for the additional use of FC testing as the patient judges appropriate. Is there a demand for or potential patient benefit from this more personalised sort of approach?

FC testing is now increasingly available as a ‘point of care test’. This has the potential to support bringing monitoring of Crohn’s disease activity closer to the patients home.

Aims:
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We propose to conduct a pilot study, recruiting up to 30 local patients who are established on treatment for their Crohn’s disease. We will deliver an ‘intervention package’ comprising the training of patients to use the care pathway and their provision with FC ‘point of care’ testing kits. During the course of the pilot study patients will provide samples for FC testing: (i) in line with the existing care pathway and (ii) at their own discretion, should they develop symptoms that give cause for concern.

The FC result will be returned to the patient with the relevant clinical recommendation. The patient will record the FC result and document the initial intervention in an accompanying care pathway ‘passport’. This intervention may include reassurance with watchful waiting, seeking supportive treatments from primary care, repeating the test or contacting the IBD nurse specialist directly.

The aim of the proposed study is to pilot test the feasibility of an intervention package for patient centred and initiated monitoring of Crohn’s disease.

This pilot will:
• Establish patient safety/compliance with the care pathway, recommendations and fidelity to the intervention as planned
• Provide an estimate of clinical outcomes of the intervention
• Establish the analytical accuracy of the point of care test compared with laboratory ELISA test
• Identify feasibility and implementation issues relating to: delivery of the training, use of the testing equipment, primary care burden and whether there are any unanticipated consequences
• Identify patient experience and perceptions of intervention acceptability, impact upon their self-care management, and perceptions of the added value of the intervention compared with current secondary care led monitoring.

Anticipated Outcome:

The pilot will test and provide insight into the feasibility of the intervention package for patient centred and initiated monitoring of Crohn’s disease, including identification of current unmet need in this area

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