Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial

Abstract

Introduction: Children with chronic gastrointestinal symptoms are frequently seen in primary care, yet general practitioners (GPs) often experience challenges distinguishing functional gastrointestinal disorders (FGID) from organic disorders. We, therefore, aim to evaluate whether a test strategy that includes point-of-care testing (POCT) for faecal calprotectin (FCal) can reduce the referral rate to paediatric specialist care among children with chronic gastrointestinal symptoms. The study findings will contribute to improving the recommendations on FCal use among children in primary care.

Methods and analysis: In this pragmatic cluster randomised controlled trial, we will randomise general practices into intervention and control groups. The intervention group will use FCal-POCT when indicated, after completing online training about its indication, interpretation and follow-up as well as communicating an FGID diagnosis. The control group will test and treat according to Dutch GP guidelines, which advise against FCal testing in children. GPs will include children aged 4-18 years presenting to primary care with chronic diarrhoea and/or recurrent abdominal pain. The primary outcome will be the referral rate for children with chronic gastrointestinal symptoms within 6 months after the initial assessment. Secondary outcomes will be evaluated by questionnaires completed at baseline and at 3- and 6-month follow-up. These outcomes will include parental satisfaction and concerns, gastrointestinal symptoms, impact of symptoms on daily function, quality of life, proportion of children with paediatrician-diagnosed FGID referred to secondary care, health service use and healthcare costs. A sample size calculation indicates that we need to recruit 158 GP practices to recruit 406 children.

Ethics and dissemination: The Medical Research Ethics Committee (MREC) of the University Medical Center Groningen (The Netherlands) approved this study (MREC number: 201900309). The study results will be made available to patients, GPs, paediatricians and laboratories via peer-reviewed publications and in presentations at (inter)national conferences.

Trial registration number: The Netherlands Trial Register: NL7690 (Pre-results).

Keywords: functional bowel disorders; inflammatory bowel disease; paediatric gastroenterology; primary care.

Figure 1

Study design. * Secondary outcomes evaluated by questionnaires will only be assessed in children who provide informed consent. We estimate that 50% of the recruited children will provide informed consent. FCal, faecal calprotectin; GP, general practitioner; POCT, point-of-care testing.

Figure 2

Test strategy in the intervention group. ^a Per definitions in table 1. ^b Refer to paediatrician if the repeated calprotectin after 1 month is >50 µg/g to prevent diagnostic uncertainty among GPs, parents and children. FCal, faecal calprotectin; FGID, functional gastrointestinal disorder; GP, general practitioner; IBD, inflammatory bowel disease.

Figure 3

Study timeline at each GP practice. After a GP practice agrees to participate in the study, it is randomised to either the intervention or control group. Shortly thereafter, research staff visits the practice to explain study procedures, which marks the start of the 12 month inclusion period. GPs in the intervention group complete the online training before this visit. Children presenting with chronic gastrointestinal symptoms before the inclusion period starts are not eligible. Follow-up is 6 months for each child. GP, general practitioner.