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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 is a NA study that has completed, run by Indiana University. The registered enrollment target is 33 participants.
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.
Interventions
- BEHAVIORAL Clinical Decision Support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2021-11-22 |
| Est. Completion | 2025-02-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04773158
The ClinicalTrials.gov registry entry for NCT04773158 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Clinical Decision Support is the first listed.
NCT04773158 reports 0 study locations.
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.
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