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NCT04773158 · ClinicalTrials.gov registry record · NA

Systematic Pediatric Assessment of Rome Criteria (SPARC)

A NA study, sponsored by Indiana University.

Completed
Registry status
NA
Development phase
33
Enrollment target

NCT04773158: Completed NA study, sponsored by Indiana University.

NCT04773158 is a NA study that has completed, run by Indiana University. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04773158, a NA study, has completed, sponsored by Indiana University.

COMPLETED
Registry status
NA
Development phase
33 participants
Enrollment target

Study Summary

While gastroenterologists care for many of the pediatric patients with Functional gastrointestinal disorders (FGIDs), the majority of the burden continues to be borne by general pediatricians, especially with respect to initial diagnosis. Unfortunately, FGIDs are often diagnosed incorrectly by primary care providers, and patients often wait months to years before a correct diagnosis is made, and effective treatment is begun. Furthermore, primary care providers are often unaware of recent guideline changes or the evidence base for children with FGIDs, leading to overuse of testing, inappropriate or ineffective treatment, and increased costs. Given this information, it is essential that we develop interventions that target pediatric primary care providers to improve their care for children with FGIDs. The investigators propose that using a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for diagnosis and evidence-based care for FGIDs will improve the (1) accuracy of diagnosis and (2)\_ effectiveness of clinical care. A CDSS has advantages with respect to guideline adherence and automated diagnosis, because it can provide focused, real-time, patient-specific data to the clinician. The investigators hypothesize that automation of screening, diagnosis, and management of FGIDs using the Rome IV criteria will result in improved resolution of FGIDs (primary outcome), as well as decreased utilization of medical services (secondary outcomes). This hypothesis will be tested utilizing a randomized controlled trial. The intervention clinic sites will be provided access to both the FGIDs Screening Module and the Treatment Module. The control clinics will have the FGIDs Screening Module. However, control clinics will not have access to the FGIDs Treatment Module. These clinic sites will be given access to the pre-screener form section of the module, so that providers are made aware of a positive screen.

Primary Outcome

This measure will be determined for the Rome IV diagnoses of: Aerophagia, Rumination, Functional Constipation, Cyclic Vomiting Syndrome (CVS), Functional Diarrhea, Non Retentive Fecal Incontinence, Functional Vomiting, Functional Nausea, Functional Dyspepsia- Postprandial Distress Subtype, Functional Dyspepsia- Epigastric Pain Syndrome Subtype, Irritable Bowel Syndrome (IBS), Abdominal Pain otherwise Not Specified, and Abdominal Migraine. The presence or absence of meeting criteria for the Rome

Interventions

  • BEHAVIORAL Clinical Decision Support

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2021-11-22
Est. Completion 2025-02-06
Phase NA
Indiana University

890 total trials

What the finished NCT04773158 record still lists

NCT04773158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Clinical Decision Support is the first listed.

NCT04773158 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04773158 about?

NCT04773158 is a clinical study titled "Systematic Pediatric Assessment of Rome Criteria (SPARC)". While gastroenterologists care for many of the pediatric patients with Functional gastrointestinal disorders (FGIDs), the majority of the burden continues to be borne by general pediatricians, especially with respect to initial diagnosis. Unfortunately, FGIDs are often diagnosed incorrectly by prima...

What is the current status of trial NCT04773158?

This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2021-11-22. Estimated completion is 2025-02-06.

What interventions are being tested in trial NCT04773158?

The interventions under investigation include: Clinical Decision Support (BEHAVIORAL).

Who is sponsoring clinical trial NCT04773158?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04773158's enrollment target sits among peer trials

33 1574th of 2000 higher than 423 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04773158, the US trial registry maintained by the National Library of Medicine. NCT04773158 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.