Fecal calprotectin guided referral strategy in children in primary care

Rationale: Children with chronic gastrointestinal symptoms are common in primary care. Whereof 90% suffer from functional gastrointestinal disorders (FGID), i.e. gastrointestinal symptoms without a known medical explanation. Inflammatory bowel disease (IBD) needs to be eliminated before diagnosing FGID. It is a diagnostic challenge to differentiate between FGID and IBD, because the clinical presentations can be very similar. The impact of the promising faecal calprotectin (FCal) test that may reduce blood tests and referrals without missing a child with IBD is not yet evaluated. Additionally, it is unknown whether testing with FCal in primary care will improve clinical outcomes of the children, e.g. patients concern and reduction in the impact of gastrointestinal symptoms. Objective: To assess whether FCal point-of-care (POC) testing in primary care reduces referral rates of children with chronic gastrointestinal symptoms to the paediatrician, improves parental concerns and satisfaction, impact of symptoms on daily functioning, quality of life, and cost-efficiency of care, as compared to usual care. Study design: Cluster randomised controlled trial with 6 months follow-up. Study population: Children, aged 4 to 18 years, presenting with chronic diarrhoea or recurrent abdominal pain in primary care. Intervention: One group of general practitioners (GPs) will be instructed to use FCal POCT test and be subjected to an accredited training with instructions on indication, execution, interpretation, communication, reporting and follow-up of FCal POCT (intervention group). The other group of GPs will be instructed to provide care as usual according to the Dutch Society of GPs guideline for children with abdominal pain, which recommends no testing of FCal (control group). Main study parameters/endpoints: Primary outcome is the proportion of referrals in children with chronic GI symptoms within 6 months after index consultation in primary care. Secondary outcomes are parental concerns and satisfaction, impact of symptoms on daily functioning, quality of life, use of health services, and cost-effectiveness during 6 months follow-up.

Point of care testing with Fcal POCT will reduce substantial the referral rate of children with chronic GI symptoms to the paediatrician.

Measurements will be at baseline, 3 and 6 months follow-up.

The use of FCal POCT in primary care. The general practitioners will receive an online training with instructions on indication, execution, interpretation, communication, reporting and follow-up of FCal POCT.