Point of care testing with Fcal POCT will reduce substantial the referral rate of children with chronic GI symptoms to the paediatrician.
ID
Bron
Verkorte titel
Aandoening
- Maagdarmstelseltekenen en -symptomen
Aandoening
Inflammatory Bowel Disease
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Medische hulpmiddelen
Uitkomstmaten
Primaire uitkomstmaten
Proportion referrals in children with chronic GI disorders within 6 months after initial presentation in primary care.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Point of care testing with Fcal POCT will reduce substantial the referral rate of children with chronic GI symptoms to the paediatrician.
Onderzoeksopzet
Measurements will be at baseline, 3 and 6 months follow-up.
Onderzoeksproduct en/of interventie
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.
Publiek
Gea Holtman
0031642637125
g.a.holtman@umcg.nl
Wetenschappelijk
Gea Holtman
0031642637125
g.a.holtman@umcg.nl
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- children, aged 4 to 18 years, with - chronic diarrhoea (soft or watery stool, matching scores 5–7 of the Bristol Stool chart, for >2 weeks or >2 episodes of 3 days in the past 6 months) OR - recurrent abdominal pain (>2 episodes of 3 days in the past 6 months)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- a history of chronic organic gastrointestinal disease - an endoscopic evaluation, referral to specialist care or FCal result within the preceding 6 months - difficulty in understanding questionnaires due to cognitive impairment or language problems
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7690 |
Ander register | ZonMw : 852001930 |