Clinical Decision Support for Functional Gastrointestinal Disorders

(SPARC Trial)

Overseen By Stacy A Keller, RN MSN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool to help doctors better diagnose and treat children with Functional Gastrointestinal Disorders (FGIDs). FGIDs often cause stomach pain or bowel issues in children but are frequently misdiagnosed or treated incorrectly by primary care providers. The trial will determine if a computer-based support system (Clinical Decision Support) can help doctors use the latest guidelines to improve diagnosis and care. It involves two groups of clinics: one will use both a screening and a treatment tool, while the other will use only the screening tool. Children visiting a pediatric primary care clinic in the Eskenazi health system may participate in this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve pediatric care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Clinical Decision Support System is safe for improving care in pediatric FGIDs?

Research has shown that Clinical Decision Support Systems (CDSS) can sometimes provide incorrect or unsafe advice. One study found that missing information led to poor recommendations in almost 77% of cases. This underscores the need for complete and accurate data for these systems to function safely.

Despite some concerns, CDSS tools are generally well-accepted because they do not involve direct medical treatments. Instead, they assist doctors in making better decisions when diagnosing and managing conditions like FGIDs.

No harmful events have been directly linked to CDSS use. However, their effectiveness and safety depend on proper design and usage. It is crucial that doctors using these tools receive training and that the systems are regularly updated with the latest medical guidelines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of Clinical Decision Support Systems (CDSS) to improve the management of Functional Gastrointestinal Disorders (FGIDs). Unlike standard treatments that mainly rely on symptom management through medications like antispasmodics or dietary changes, this approach leverages technology to enhance decision-making in clinical settings. The trial aims to determine if providing healthcare providers with a comprehensive FGIDs Screening and Treatment Module can lead to better diagnosis and treatment outcomes. By integrating this tool into clinical practice, there is potential for more personalized and effective care, which could revolutionize how FGIDs are managed.

What evidence suggests that this Clinical Decision Support is effective for improving care for Functional Gastrointestinal Disorders?

Research has shown that using a Clinical Decision Support System (CDSS) can improve care for children with Functional Gastrointestinal Disorders (FGIDs). In this trial, the intervention arm will access both the FGIDs Screening Module and the Treatment Module of the CDSS. The CDSS employs the Rome IV criteria, guidelines for diagnosing these disorders, to assist doctors in making more accurate diagnoses. Studies have found that these systems enhance diagnosis accuracy and care quality by providing doctors with real-time, personalized advice. This can lead to better patient outcomes, such as faster symptom relief and fewer unnecessary medical tests. Overall, CDSS can make managing FGIDs more effective by ensuring treatments are based on the latest evidence. ^{4 5 6 7 8}

Who Is on the Research Team?

William E Bennett, MD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a child or teenager up to 17 years old seeing a doctor at Eskenazi health.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to the FGIDs Screening Module and, for the intervention group, the Treatment Module

12 months

Regular visits as per module requirements

Follow-up

Participants are monitored for resolution of symptoms and healthcare utilization

12 months

Phone interviews at 1, 3, 6, and 12 months

Assessment

Assessment of parental satisfaction and change in parental concern

3 months

Phone interviews at 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Decision Support

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 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 Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. withpower.com withpower.com/trial/phase-gastrointestinal-diseases-2-2021-170c9

Clinical Decision Support for Functional Gastrointestinal ... The SPARC medical study, being run by Indiana University, needs participants to evaluate whether Clinical Decision Support will have tolerable side effects ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6603811/

Evaluation of clinical outcomes in an interdisciplinary ... To evaluate outcomes with interdisciplinary treatment in pediatric patients with pain-related FGIDs and identify patient characteristics that predicted clinical ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1470211824030677

Functional gastrointestinal disorders: History taking skills in ... This article offers a framework in history taking for functional gastrointestinal disorders (FGIDs). Clinicians rely on history taking and knowledge of the ...

4. spg.pt spg.pt/wp-content/uploads/2023/03/18-Design-of-Treatment-Trials-for-Functional-Gastrointestinal-Disorders.pdf

Design of Treatment Trials for Functional Gastrointestinal ... There are several challenges to conducting FGID treat- ment trials, including a high placebo response rate6; symptoms that are intermittent and of fluctuating ...

5. gastrojournal.org gastrojournal.org/article/S0016-5085(16)00176-1/fulltext

Design of Treatment Trials for Functional Gastrointestinal ... This article summarizes recent progress and regulatory guidance on design of trials to assess the efficacy of new therapies for functional gastrointestinal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1560426/

Impact on Clinical Decision Support Systems When the available data was input into the CDSS, the missing data elements resulted in inappropriate and unsafe recommendations in almost 77% of the encounters.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9117572/

United States Healthcare Burden of Pediatric Functional ... 22.3 million pediatric hospitalizations were captured, and 1 in 64 pediatric hospitalizations were attributed to a primary FGID hospitalization.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553725018303489

A Novel Clinical Decision Support System for ... The aim of this quality improvement study was to improve appropriate acid suppression therapy in patients admitted to ICUs in an academic medical center.