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Functional Gastrointestinal DisordersSPARCNCT04773158

Systematic Pediatric Assessment of Rome Criteria (SPARC)

A study testing Clinical Decision Support in people with Functional Gastrointestinal Disorders, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 17 years
Conditions the study is for
Functional Gastrointestinal Disorders
What is being tested?
Clinical Decision Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
22 Nov 2021to 6 Feb 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Any patient between the ages of 0 through 17 presenting to a pediatric primary care clinic in the Eskenazi health system and the Primary Care Physician who sees them

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Eskenazi Health

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Systematic Pediatric Assessment of Rome Criteria

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.

Read the detailed description

Functional gastrointestinal disorders (FGIDs) are extremely common in children and adolescents, and represent a wide range of disorders that are related to the gastrointestinal tract, but have no clear structural, anatomic, or histopathologic cause. FGIDs represent an enormous burden on patients and families, and patients with these functional disorders have much higher health care utilization and related costs. As there are no biochemical markers or structural abnormalities that can be used to diagnose these disorders in children objectively, FGIDs are diagnosed according to the symptom-based Rome criteria. While gastroenterologists care for many of the pediatric patients with 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 to develop interventions that target pediatric primary care providers to improve their care for children with FGIDs. This study proposes 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. Studies of barriers to guideline implementation have shown multiple factors at work: unfamiliarity with a guideline, lack of self-efficacy, or difficulty implementing the guideline components within the current workflow of a practice. CDSS can overcome many of these barriers because they are integrated with systems that routinely store and retrieve patient information and can improve workflow by providing clinicians with patient-specific advice at the time of the patient visit. The study 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 for a FGID. The investigators have chosen not to have an arm without provider notification due to concern that identification of symptoms without notifying the patient's provider represented an ethical concern. If anything, this will bias towards a null result. Since FGIDs have both a high rate of relapse, and a high rate of spontaneous resolution, it is necessary to assess the pattern of symptoms across multiple time points. As such, we plan to gather various data from parents/patients at 1, 3, 6 and 12-months via phone interview. Additionally, the study will assess parental satisfaction with the screening and treatment of their child's particular FGID at the 3-month phone interview. For assessment of health care utilization, the study will look at the following variables in the 12 months after initial Rome IV screening positive: a) outpatient sick visits for any complaint; b) outpatient sick visits with an associated GI billing code; c) visits to statewide providers, including inpatient hospital stays, outpatient clinic visits, and emergency room visits; d) GI-related testing and procedures; e) use of any medications prescribed to treat Rome IV diagnoses. These data will be obtained from multiple sources including the EMR, and Indiana Network for Patient Care (INPC).

Being tested
Clinical Decision Support
Keywords
Computerized Decision Support
Medical subject headings
Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical Decision SupportBehavioural

    The intervention clinic sites will be provided access to a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for evidence-based care recommendations for functional gastrointestinal disorders (FGIDs)

Study groups in NCT04773158
Study groupRoleWhat they receive
Intervention ArmExperimentalThe intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module
Receives: Behavioral: Clinical Decision Support
Control ArmNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution of Symptoms From Initial Rome IV Diagnosis at 3 Months Using an Age-appropriate Rome IV Questionnaire. Number of Participants Who no Longer Meet Rome IV Criteria.

    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 IV diagnoses will be coded as a binary variable (true/false) to represent resolution of symptoms.

    Measured: 3 months from initial diagnosis

  2. 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. Number of Participants With Ongoing Concern.

    This change will be measured by a single likert scale question asked in the FGID Screening module (Baseline) and again at the 3 month follow up phone survey. , The parent is able to indicate their degree of concern about the symptomology associated with the Rome IV diagnosis. The presence or absence of ongoing concern will then be coded as a binary variable (true/false).

    Likert scale: Not at all concerned, Slightly concerned, Somewhat concerned, Moderately concerned, Extremely concerned

    Measured: Baseline and 3 months from initial diagnosis

Secondary outcomes (7)
  1. 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

    This change will be measured by a single likert scale question asked in the FGID Screening module (Baseline) and again at the 3 month follow up phone survey. , The parent is able to indicate their degree of concern about the symptomology associated with the Rome IV diagnosis. The presence or absence of ongoing concern will then be coded as a binary variable (true/false).

    Likert scale: Not at all concerned, Slightly concerned, Somewhat concerned, Moderately concerned, Extremely concerned

    Measured: 1 and 6 months from initial diagnosis

  2. Parent Satisfaction With Screening Measured at 3 Months Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied]

    This was measured by two likert scale questions asked in the 3 month follow up phone call.

    Measured: 3 months from initial diagnosis

  3. Parent Satisfaction With Treatment Measured at 3 Months Will be Measured Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied]

    This will be measured by two likert scale questions asked in the 3 month follow up phone call. Satisfaction with screening and treatment of FGID will be assessed.

    Measured: 3 months from initial diagnosis

  4. Resolution of Symptoms From Initial Rome IV Diagnosis at 1 Month Using an Age-appropriate Rome IV Questionnaire.

    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 IV diagnoses will be coded as a binary variable (true/false) to represent resolution of symptoms.

    Measured: 1 months from initial diagnosis

  5. Resolution of Symptoms From Initial Rome IV Diagnosis at 6 Months Using an Age-appropriate Rome IV Questionnaire.

    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 IV diagnoses will be coded as a binary variable (true/false) to represent resolution of symptoms.

    Measured: 6 months from initial diagnosis

  6. Resolution of Symptoms From Initial Rome IV Diagnosis at 12 Months Using an Age-appropriate Rome IV Questionnaire.

    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 IV diagnoses will be coded as a binary variable (true/false) to represent resolution of symptoms.

    Measured: 12 months from initial diagnosis

  7. 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)

    The following variables will be assessed: Outpatient sick visits for any complaint, Outpatient sick visits with an associated GI billing code; Visits to statewide providers, including inpatient hospital stays, outpatient clinic visits, and emergency room visits; The occurrence of any GI-related testing and procedures - specifically radiologic, laboratory testing, endoscopy, and surgical procedures related to GI diagnoses; The use of any medications prescribed to treat Rome IV diagnoses - specifically acid- suppressants, antispasmodics, antidepressants, stool softeners and laxatives, and pro-motility agents

    Measured: 12 months from initial diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2021
  2. Study start22 Nov 2021
  3. Primary completion14 May 2024
  4. Study completion6 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Will perform cluster randomization by clinic. The unit of randomization will be the clinic site, but the unit of analysis will be the individual patient.
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04773158
Sponsor's protocol ID
1811325201
Other IDs
R01DK118433
Acronym
SPARC
Status last verified
Feb 2026
First submitted
11 May 2020
Last updated
13 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Decision Support in people with Functional Gastrointestinal Disorders, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of Symptoms From Initial Rome IV Diagnosis at 3 Months Using an Age-appropriate Rome IV Questionnaire. Number of Participants Who no Longer Meet Rome IV Criteria. (time frame: 3 months from initial diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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