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Clinical Decision Support for Functional Gastrointestinal Disorders (SPARC Trial)

N/A

Waitlist Available

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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 6 and 12 months from initial diagnosis

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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