Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04773158
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2020-05-11
Brief Title:
Systematic Pediatric Assessment of Rome Criteria SPARC
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Systematic Pediatric Assessment of Rome Criteria
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARC
Brief 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
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 patients 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 parentspatients at 1 3 6 and 12-months via phone interview Additionally the study will assess parental satisfaction with the screening and treatment of their childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK118433 | NIH | None | httpsreporternihgovquickSearchR01DK118433 |