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Clinical Decision Support for Functional Gastrointestinal Disorders (SPARC Trial)

N/A
Recruiting
Led By William E Bennett, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 6 and 12 months from initial diagnosis
Awards & highlights

SPARC Trial Summary

This trial will test whether a Clinical Decision Support System can help gastroenterologists more accurately diagnose and treat Functional gastrointestinal disorders in children.

Who is the study for?
This trial is for children aged 0-17 with gastrointestinal issues, seen at pediatric primary care clinics in the Eskenazi health system, and their doctors. There are no exclusions, meaning all such patients and physicians can participate.Check my eligibility
What is being tested?
The study tests a Clinical Decision Support System (CDSS) that helps doctors diagnose and treat functional gastrointestinal disorders using updated guidelines. It's a randomized trial where some clinics get both diagnosis and treatment modules, while others only get the diagnosis module.See study design
What are the potential side effects?
Since this intervention involves a decision support tool rather than medication or surgery, traditional side effects aren't expected. However, there may be indirect effects on patient care depending on the system's accuracy.

SPARC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 6 and 12 months from initial diagnosis
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6 and 12 months from initial diagnosis for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in parental concern (for the Rome IV diagnoses of Infant Regurgitation, Infant Dyschezia, and/or Infant Colic from initial Rome IV diagnosis at 3 months using likert scale questionnaire
Resolution of symptoms from initial Rome IV diagnosis at 3 months using an age-appropriate Rome IV questionnaire.
Secondary outcome measures
Change in parental concern (for the Rome IV diagnoses of Infant Regurgitation, Infant Dyschezia, and/or Infant Colic from initial Rome IV diagnosis at 1 an 6 months using likert scale questionnaire
Parent Satisfaction will be measured using a likert scale questionnaire
Rate of health care utilization will be assessed 12 months after initial Rome IV Screening positive. Variables will be coded as binary variables (true/false)
+1 more

SPARC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
The intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module
Group II: Control ArmActive Control1 Intervention
The control clinics will have the Functional gastrointestinal disorders (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 for a FGID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clinical Decision Support
2019
N/A
~37100

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,376 Previous Clinical Trials
4,315,167 Total Patients Enrolled
Indiana UniversityLead Sponsor
993 Previous Clinical Trials
1,094,689 Total Patients Enrolled
William E Bennett, MDPrincipal InvestigatorIndiana University School of Medicine
2 Previous Clinical Trials
146 Total Patients Enrolled

Media Library

Clinical Decision Support Clinical Trial Eligibility Overview. Trial Name: NCT04773158 — N/A
Functional Gastrointestinal Disorders Research Study Groups: Intervention Arm, Control Arm
Functional Gastrointestinal Disorders Clinical Trial 2023: Clinical Decision Support Highlights & Side Effects. Trial Name: NCT04773158 — N/A
Clinical Decision Support 2023 Treatment Timeline for Medical Study. Trial Name: NCT04773158 — N/A
~71 spots leftby Sep 2024
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