Kosteneffectiviteit van het gebruik van fecaal calprotectine point of care test bij kinderen met chronische gastro-intestinale klachten in de huisartsenpraktijk

RESEARCH QUESTION

Does point of care testing with faecal calprotectin point of care test (Fcal POCT) in primary care reduce referral rates of children with chronic gastrointestinal (GI) symptoms to the paediatrician?

HYPOTHESIS

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

STUDY DESIGN

Clustered randomised controlled trial with 6 months follow-up.

POPULATION

Children, aged 4 to 18 years, presenting with chronic diarrhoea or recurrent abdominal pain in primary care.

INTERVENTION

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.

USUAL CARE/COMPARISON

Care as usual according to the Dutch Society of GPs guideline for children with abdominal pain, which recommends not testing for FCal.

OUTCOME MEASURES

Primary: proportion referrals in children with chronic GI disorders within 6 months after initial presentation in primary care.

Secondary: proportion referrals of children with functional GI disorders, 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.

SAMPLE SIZE CALCULATION/DATA ANALYSIS

We need to include 402 children, from 154 practices, to determine a reduction of referrals from 17% to 7%. Varying block size randomisation will be conducted at the level of GP practices. We will determine the effect of POCT FCal on the primary outcome using a logistic multilevel regression model.