The ImproveCareNow research program is designed for continuous, multidisciplinary exploration of pediatric IBD and its treatment and management. Together, we ask and answer questions that matter to our community and translate our results into real-world improvements in clinical care and patient outcomes.
Use the filters below to sort and view all our current ICN research projects and click on a project name to view additional information about each project. Learn more about the operational definitions for each filter.
⭐ If you would like to participate in a study, check our list of current research opportunities.
Click on a project name to view additional information.
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Purpose: The purpose of this study is to build a risk prediction model for pediatric Crohn's disease to predict outcomes of sustained remission/flare, surgery, and hospitalization using data from ICN Registry and PCORnet.
Specific Aims:
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Leveraging longitudinal data from ICN registry and PCORnet, and previously developed methods in assessing and stratifying disease activities, this study proposes to apply data analytics and visualization to facilitate efficient decision support for personalized care and risk prediction in pediatric Crohn’s disease. We aim to develop a machine-learning based clinical pathway learning algorithm for pediatric Crohn’s disease that predicts for 3 outcomes of interests: (1) sustained remission/flare, (2) surgery, and (3) hospitalization. Stratifying patients by their risk levels using PCDAI and sPCDAI, we will infer the common disease progression trajectories that are unique to each patient subpopulation from data, which we further use for prediction of future patient states.
Start Date: March 2017
Contact: Yiye Zhang
Read more about the SHINE-2 study here!
Purpose: The purpose of this study is to evaluate the perspectives of pediatric and adult gastroenterologists on the clinical utility and feasibility of the Pediatric IBD Medical Transfer Summary (PIBD-MTS) tool, which is aimed to synopsize the salient aspects of a young adult's prior pediatric medical course, as a tool to be shared with the receiving adult provider in the transfer of care process.
Specific Aims:
The ICN Transition and Transfer Committee developed the PIBD-MTS as a collaboration amongst pediatric and gastroenterologists, psychologists, young adults of PAC, and parents of PWG. The summary has undergone multiple revisions, including adaption for electronic medical records. Feedback from both pediatric and adult gastroenterologists has been largely qualitative, with infrequent patient-specific feedback.
- We will assess pediatric provider satisfaction with the PIBD-MTS, including time spent for completion and content
- We will assess adult provider satisfaction with the PIBD-MTS, including time spent reviewing information, completeness, and quality of information related to IBD care.
Study Period: March 2021-March 2023
Contact: Jeanne Tung
Purpose: The purpose of this study is to determine if ulcerative colitis pediatric patients can maintain remission on a 1.6 mg vs. 2.4 mg weight-based dosing of mesalamine DR (Delzicol).
Specific Aims:
Using adult studies as a guide, we aim to compare two weight-based, parallel arms of 2.4 mg vs 1.6 mg in maintaining UC remission over 26 weeks using the modified Mayo Score and other Mayo score derivatives. Pediatric patients will be aged 5-17 and must have been on a stable dose of mesalamine or 5 ASA equivalent for 30 days prior to enrollment and must be in remission for 30 days. Dosing choices are taken from adult maintenance mesalamine dosing.
Study Period: May 2022-March 2024
Contact: Charlotte Glenn, MD - AbbVie
Purpose: The purpose of this study is to understand the current ways that healthcare professionals (HCPs) are assessing and intervening related to fatigue in pediatric IBD, and understand the current self-reported experience of fatigue in pediatric patients in clinical remission and those with active disease.
Specific Aims:
- Identify the perception of prevalence of fatigue HCPs have regarding pediatric IBD patents
- Identify the way(s) in which HCPs assess for fatigue in pediatric IBD patients
- Identify the way(s) in which HCPs intervene related to fatigue in pediatric IBD patients
- Identify potential reported differences between HCPs in assessing and intervening related to fatigue in pediatric IBD (e.g., are there descriptive differences between how a pediatric GI and a pediatric psychologist assess and intervene?)
- Identify the self-reported fatigue of patients in clinical remission and patients with active disease
Study Period: January 2022-October 2022
Contact: Sabina Ali
Primary Investigator: Nicole Davidson - Nationwide Children's Hospital
Purpose:
Inflammatory bowel disease (IBD) is a chronic immune mediated condition that impacts not only the physical health of patients but also their psychosocial wellbeing and quality of life. Multidisciplinary care is advised in the care of children and adolescents with IBD. Models of multidisciplinary care for pediatric IBD have been described in the literature but real-world access to multidisciplinary care as well as provider attitudes and perceived barriers and facilitators to it remain largely unknown. Michel et al described the described the approach to the pediatric IBD medical home at our IBD center (Nationwide Children's Hospital) in a study published in 2022 (Michel et al. 2022).
Our center has access to several resources given the size and scope of our institution but we recognize that these resources are not available at all centers. In a survey study by Winnick et al, ICN centers were surveyed to assess their access to psychosocial support services for IBD patients. The study found that the majority of centers had access to psychosocial support, however most of these providers were not dedicated exclusively to IBD and they were often only available during limited hours (Winnick et al. 2023). This study would be helpful to assess what common barriers in access to this type of care across ICN centers in the US, while acknowledging that ICN centers do not encompass all centers providing pediatric IBD care. Analyzing this data will allow pediatric IBD centers to assess care gaps and advocate for improved care.
Aims & Hypothesis: This study aims to understand availability and access to multidisciplinary care for children with IBD across US ICN centers. It also aims to explore provider attitudes, barriers, and facilitators of care. We hypothesize that access to multidisciplinary care will vary widely across US ICN centers. Providers will feel positively toward multidisciplinary care for children with IBD, but identify multiple personnel, local, and system-level barriers to care access and delivery.
Funding Source: N/A
Study Period: January 2024
Recruitment Status: Currently recruiting participants
Contact: [email protected]
Principal Investigator: Ross Maltz, MD; Nationwide Children's Hospital
Overall Study Question: Evaluate variation in prescribing habits of IV anti-TNF therapies across the pediatric IBD community. Evaluate the safety and efficacy of non-medical switches from the originator to a biosimilar
Specific Aims:
- To evaluate infliximab use over time for patients who are anti-TNF naïve, to determine if biosimilar use is increasing nationally, variation amongst practices, geographic regions, by commercial vs Medicaid insurance, and race.
- To evaluate long-term clinical outcomes of pediatric patients initiated on an infliximab biosimilars vs the originator.
- Evaluate how often switching from the originator to a biosimilar are occurring within the ICN Network. Determine if non-medical switching adversely affects clinical outcomes in pediatric IBD patients including the impact upon clinical remission in addition to anti-TNF drug and antibody levels. Evaluate how often patients are switching back to the originator or to a different therapy class.
Study Period: Beginning in May 2022
Contact: Ross Maltz, MD
Primary Investigator: Jennie David, Ph.D. - Nationwide Children's Hospital
Purpose:
Pediatric patients with IBD are known to have higher rates of psychosocial concerns than peers without IBD, including body image complexities and disordered eating behaviors (Claytor et al., 2020; David et al., 2017; David et al.,2021). While there is emerging understanding of protective and risk factors amongst patients with IBD regarding their relationships with their bodies and food including negative weight-based interactions, there is not yet an understanding of how pediatric IBD medical providers perceive patients' weights and body sizes and if the weight stigma that has been identified in adults with IBD exists (Guo et al., 2020) in pediatrics. Future interventions to optimize psychosocial health and reduce body image and disordered eating risk in pediatric IBD may be limited in impact without exploring how, if at all, weight stigma beliefs amongst medical providers contributes to body image and disordered eating risk. Stated differently, there are likely provider-related variables that serve as protective or risk factors for pediatric IBD patients' body image and relationship with food. The foundational work to understand if weight stigma is present amongst pediatric IBD medical providers has not yet been completed. This work is critically needed for future studies to understand how weight stigma may impact patients' psychosocial health and care and to inform future patient, provider, and system levels interventions.
Aims:
1) Characterize weight stigma amongst pediatric IBD medical providers,
2) Explore potential differences in weight stigma by gender, weight status, and race
Funding Source: N/A
Study Period: Starting April 2023
Recruitment Status: Currently recruiting participants
Contact: [email protected]
Overall Study Question: How does the family and patient engagement process impact which advocates become centrally involved in the Collaborative Learning Health Systems operations?
Specific Aims: We will use qualitative interviewing methods to understand the experiences and practices of different groups involved in the patient engagement process within Collaborative Learning Health Systems. We have developed interview guides for each stakeholder group (patients/parents, healthcare providers, and engagement teams). These interview guides ask a range of questions to understand organizational processes, personal experiences, and professional experiences in order to elicit mechanisms of patient engagement and barriers and facilitators in patient engagement processes.
Study Period: Beginning in April 2022
Contact: Becky Woolf
Purpose: This study aims to determine the predictive variables of pediatric CD patients who do not reach remission within two years of diagnosis.
Specific Aims: This group of pediatric patients will be compared with CD patients who do go into remission within two years of diagnosis in order to find predictors of (non-) remission, correlations, define 'at risk' patients and asses it’s impact on treatment strategy (drugs, strategy and closer follow-up).
Study Period: April 2023-December 2024
Contact: Gigi Veereman
Purpose: The purpose of this study is to determine the predictive variables for pediatric UC patients who do or do not reach remission within two years of diagnosis
Specific Aims:
This group of pediatric patients will be compared with UC patients who do go into remission within two years of diagnosis in order to find predictors of (non-) remission, correlations, define 'at risk' patients and asses it’s impact on treatment strategy (drugs, strategy and closer follow-up).
Study Period: April 2023-December 2024
Contact: Jonathan Van Hecke
Primary Investigator: Sabina Ali
Purpose: Social Determinants of Health (SDoH) has become an increasingly relevant and highlighted topic in healthcare, with the consensus among public health organizations being that SDoH are an important factor in health and impacting patient care. However, there has been limited guidance and recommendation into how to practically implement approaches to integrating SDoH screening into clinical care. For this reason we seek to directly evaluate the perceptions around SDoH screening among healthcare providers and investigate what key elements and barriers are common within SDoH screening practices.
Aims & Hypothesis: Our specific aims are to investigate the key steps and/or barriers involved in administering Social
Determinants of Health (SDoH) screening as well as assess differences in providers' perspective on SDoH screenings
and understand what factors may affect these perspectives. Certain factors, including knowledge and focus on Social Determinants of Health (SDoH), are more likely to result in having an established SDoH screening and being knowledgable about the screening process.
Study Period: January 2024
Recruitment Status: Currently recruiting participants
Contact: [email protected]
Overall Study Question: Initial data review of the ICN registry has found that since 2014, nearly 600 patients have undergone colectomy. We suspect that deeper review of this patient population is likely to provide insight for clinical care in addition to identifying variation in care delivery across the ICN network, thus making this patient cohort important for further data analysis. Ultimately, this deeper evaluation could provide insight toward improving patient outcomes.
Specific Aims: We would like to review clinical variables including BMI prior to colectomy, medication exposures prior to colectomy, time from diagnosis to colectomy, incidence rates of colectomy among patients newly diagnosed with UC in ICN database.
We also suspect there could be variation in colectomy rates or treatment approaches across the collaborative between academic vs nonacademic center, regional variation, public vs commercial insurance, and possible trends of biological treatment prior to colectomy.
Study Period: starting in January 2023
Contact: Brendan Boyle and Sabina Ali
Principal Investigator: Kevin Hommel, PhD - Cincinnati Children's Hospital Medical Center
Purpose: Those participating in intervention groups may experience improvements in their treatment adherence, better self-monitoring, and goal setting. Participants may benefit from connections made via ICN conferences. Improved engagement in their own care may be associated with better health outcomes. This study may have a significant impact on patient care and empowerment in several ways through improving access to self-management care and
facilitating the process of communicating information to patients.
Specific Aims/Hypothesis
This study will assess the efficacy, feasibility, and acceptability of the SMART-IBD app and WINWIN resources on clinical outcomes in adolescents and young adults with IBD.
- Hypothesis 1: Compared to patients not using the SMART-IBD app, those using the app will have better disease activity score (primary outcome) and better symptoms, self-efficacy, and health-related quality of life (secondary
outcome). - Hypothesis 2: Compared to patients not in the WINWIN condition, those getting WINWIN will have better disease activity (primary outcome) and symptoms, self-efficacy, and health-related quality of life (secondary outcome).
- Hypothesis 3: Compared to any other condition, patients with combination SMART-IBD and WINWIN (What I Need, When I Need It) will have better disease activity (primary outcome) and symptoms, self-efficacy, and health-related quality of life (secondary outcome).
Funding Source (Year Awarded): The David R. Clare and Margaret C. Clare Foundation
Study Period: 11/1/24 - 10/31/28
Contact: [email protected]
Purpose: The purpose of this study is to evaluate patient characteristics and treatment patterns that may be associated with diagnostic delay.
Specific Aims:
- Determine the variation in height z-score at diagnosis
- Determine the association between height z-score at diagnosis and socio-demographic information
- Determine association between growth stunting at diagnosis and variation in treatment selection and disease outcomes
Contact: Joann Samalik
Purpose: The purpose of this study is to refine proactive TDM processes to personalize care in the ImproveCareNow (ICN) rapid Learning Health Network of >30,000 children and 110 care centers in an effective and equitable way.
Specific Aims:
- Describe variation in the use of anti-TNF therapy and TDM at the patient and practice levels.
- Assess whether anti-TNF drug monitoring is associated with health outcomes, and to determine the extent to which they are explained by patient and practice level factors.
Contact: Jennifer Dotson and Jasbir Dhaliwal
Purpose: This current study aims to understand the lived experiences of key stakeholder groups (patients, parents, and providers) who have used this SDM tool. Given the exploratory and qualitative nature of this study, there are not primary hypotheses to be tested. The research team hopes that this study will provide insights of patients, parents, and providers into the impact, utility, and effectiveness of this tool for pediatric IBD patients considering surgery.
Study Period: January 2022-May 2022
Contact: Kelly Sandberg
Overall Study Question: What is the experience of patients with inflammatory bowel diseases (IBD) following a switch of infusion sites?
Specific Aims: We aim to evaluate the experience of patients with Inflammatory Bowel Diseases (IBD) following their transfer of care from one infusion site to another. Based on IBD patients’ experience, we will assess the need for intervention to improve transfer of infusion sites.
Study Period: Beginning in April 2022
Contact: Sirine Belaid
Purpose: Our primary aim is to examine the frequency of normal laboratory results (i.e. hemoglobin, c-reactive protein, erythrocyte sedimentation rate, albumin, and fecal calprotectin) in the at the time of IBD diagnosis, prior to initiating medical therapy. A secondary aim will be to determine the variation in frequency of normal labs between subgroups of patients (disease type, age at diagnosis, race, ethnicity, gender, etc.).
Primary Outcome: The proportion of patients with normal laboratory findings at diagnosis, prior to initiating medical therapy.
Study Period: March 2022 - August 2023
Contact: Nicholas Litchin, Jeremy Adler
Purpose: Crohn's disease causes chronic bowel inflammation which can lead to strictures, fistulas, growth stunting, and other complications if inadequately controlled. We typically monitor inflammation via symptoms and laboratory monitoring. In the absence of symptoms, elevated inflammatory markers (erythrocyte sedimentation rates, c-reactive protein) is sometimes referred to as "silent Crohn's disease". It is unclear how often silent Crohn's disease occurs, or what the implications are. There is some evidence in adults that silent Crohn's disease is associated with increased risk of hospitalization. This has not been evaluated in children.
Specific Aims:
1. Determine the frequency of silent Crohn's disease in children with Crohn's disease in the ImproveCareNow
Network registry.
2. Determine the association between silent Crohn's disease and risk of disease-related complications including
strictures, fistulas, perianal disease, and short stature.
Contact: Jeremy Adler
Purpose: The purpose of this study aims to investigate whether the initial diagnostic evaluation and treatment of pediatric inflammatory bowel disease has changed as a result of the current COVID-19 pandemic.
Study Period: March 2019-June 2020
Contact: Melissa Shapiro
Purpose: Although biologic therapies, such as anti-TNF, have improved outcomes, up to 30% have no initial response (primary nonresponders) while treatment responders frequently lose response over the following years. There is a crucial need to individualize Crohn’s disease therapy by utilizing a patients’ immune profile to both predict and monitor therapeutic responses over time to reduce costs associated with poorly controlled Crohn’s. Our grant proposal is centered on the primary hypothesis that proactive monitoring of neutrophil CD64, soluble CD64 and infliximab trough concentrations at the end of induction will provide clinicians with treatment targets in order to improve rates of secondary nonresponse.
Primary/Secondary Outcomes:
- Primary: Neutrophil CD64 index and soluble CD64 and infliximab response.
- Secondary: Neutrophil CD64 index, soluble CD64 and infliximab concentration.
Funding Source Trustee Award, CCHMC, funded 2016
Study Period: July 2016- October 2020
Contact: Study Coordinator, Kimberly Jackson
Primary Investigator: Dr. Marian Pfefferkorn, Dr. Gitit Tomer, Dr. Chetan Mandelia, Dr. Michael Kurtz
Purpose: The investigational product, Budesonide Extended-Release tablet, is a glucocorticosteroid that is administered orally. UCERIS® (budesonide) extended release 9mg tablets was approved for adults in 2013 for the induction of remission in adult patients with active, mild-to-moderate UC, and may provide a useful therapeutic option for pediatric patients with UC.
It's an advantageous therapy because it has a hard enteric capsule that inhibits systemic absorption as it travels through the patient's body to the site of disease activity, where it will be 90% absorbed and delivered along the inflamed areas of the colon, thus making it possible to be used as a long-term therapy. Typical steroid therapies risk systemic exposure in the body and are not a long-term solution for children because they disrupt hormones, growth, etc. This medicine is also an alternative to costly biologic therapies. Various formulations of budesonide are approved in the US for therapeutic areas including allergic rhinitis, asthma, and inflammatory bowel disease (IBD; including both Crohn's disease [CD] and Ulcerative colitis (UC).
Aims & Hypothesis: This study aims to put inflammation into remission without the cost of biologics or risk of other systemic steroids. The primary objective of this study is to evaluate the efficacy and safety of a low and a high dose of budesonide extended-release tablets in pediatric subjects with active, mild to moderate UC. The secondary objective is to evaluate the pharmacokinetics of budesonide after oral administration of budesonide extended-release tablets in pediatric subjects with active, mild to moderate UC. The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy.
Study Period: May 2024
Contact: [email protected]
Principal Investigator: Disha Subramaniam, PhD Student / Digestive Disease Pre-doctoral Fellow, University of North Carolina at Chapel Hill
Purpose:
This work will be the first to evaluate multiple approaches to addressing missing outcome data in an external control arm for pediatric Crohn's disease, ultimately aiming inform innovations in pediatric IBD trials to get much-needed
treatments to children who need them.
Aims:
- Aim 1: To describe and visualize patterns of key variable missingness in the component categories of the Pediatric Crohn's Disease Activity Index (PCDAI) in a cohort constructed from real-world registry data to serve as an external control to the treatment arm of a prior randomized trial in pediatric Crohn's disease
- Aim 2: To assess the bias and precision of common statistical approaches to handle missing PCDAI component data in a modified pediatric Crohn's disease trial data set that incorporates realistic patterns of key variable missingness based on a matched registry-based external control cohort
Study Start Date: December 15, 2024
Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.
Contact: [email protected]
Overall Study Question: Does increased engagement in a learning health network result in increased production and sharing of patient-oriented resources?
Specific Aims:
Aim 1: Measure resource production across learning health networks. Quantify and characterize the number/type of patient-oriented resources shared within ImproveCareNow (ICN) and Cystic Fibrosis Learning Network (CFLN) including blog posts, toolkits, pre-visit planning, etc.
Aim 2: Determine the relationship between the number of contributors and owners in the network and the number and type of resources produced. Describe the relationship between the number of patient/family contributors/owners and the number/complexity of patient-oriented resources produced.
Aim 3: Explore network factors that influence the rate of resource production. Interview ICN and CFLN stakeholders and perform qualitative data analysis to identify the themes related to network engagement and resource production.
Study Period: April 2022-April 2023
Contact: Maureen Dunn, MD
Purpose: Crohn’s disease causes fistulas, which are abnormal openings from the bowel to adjacent structures such as the skin, bladder, genitals, or to other loops of bowel. Fistulas frequently lead to serious and sometimes debilitating complications.
Fistulas have a major negative impact on quality of life of children and their caregivers and are highly distressing. Fistulas can cause many complications including fecal incontinence, infertility, chronic draining wounds, abscesses, and severe infections of the bladder, kidneys, uterus, or other internal structures. Fistulas are difficult to treat, requiring expensive medications and surgery, and treatments are often not effective. Strategies are needed to prevent fistulas from developing in the first place.
This study is designed to answer several important questions:
- What are the characteristics of children who at the greatest risk for developing fistulas?
- Does early selection of therapy alter the risk for fistulas among children?
- Does the risk of fistula among children change with the duration of disease?
Primary Outcomes:
- Developing perianal fistula
- Time to perianal fistula development
Secondary Outcomes:
- Medication use
- Surgery
Funding Source: Shaevsky Family Research Fund for Crohn’s Disease
Study Period: 2013-2022
Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.
Contact: ImproveCareNow Research
Purpose: Describe the phenotype of IBD in pediatric patients of Asian American ethnicity
Primary Outcome: Our hypothesis is that the phenotype of pediatric IBD in Asian American children is unique compared to the general population.
Funding Source: N/A
Study Period: Jan 2019-June 2020
Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.
Contact: Ashish Patel
Specific Aims:
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To examine the relationship between positive psychological resources (i.e., mindfulness, self-compassion, acceptance) and perceived stress, mood, disease activity, and quality of life in a sample of adolescents with IBD.
Start Date: August 2017
Contact: Anava Wren
Purpose: The purpose of this study is to evaluate the trends in biologic drug discontinuation, reasons for discontinuation, and evaluation performed prior to discontinuation in patients enrolled in the ImproveCareNow network.
Specific Aims:
- Determine the frequency of biologic drug discontinuation, including associations with patient and practice characteristics, as well as drug dosing and monitoring.
- Determine the associations between biologic drug discontinuation and adverse events, evaluation performed prior to drug discontinuation, and barriers to care.
- Develop materials and quality improvement processes aimed at reducing biologic drug discontinuation.
- BISCUIT - The Biologic dISContinUatIon sTudy - Disease Outcomes. Funded by The Gary and Rachel Glick Charitable Fund.
Study Period: January 2021-December 2022
Contact: Jeremy Adler
Purpose: Very early-onset inflammatory bowel disease (VEO-IBD) presents in children less than 6 years of age. These patients have more extensive, progressive and medically refractory disease making it phenotypically distinct from older-onset pediatric and adult IBD.
The incidence of pediatric IBD is increasing rapidly but there is no specific data for the US population. Given the paucity of information, our objective was to determine the prevalence of VEO-IBD within the ImproveCareNow (ICN) Network registry, which accounts for more than 50% of all pediatric IBD patients in the US.
Primary Outcome: Our primary outcomes are frequency of clinical remission in the VEO-IBD population and time to clinical remission. Clinical remission will be defined by normal physician global assessment (PGA), PCDAI, PUCAI, ESR or CRP.
Secondary Outcome: Our secondary outcomes will be frequency of and time to surgery (specifically, colectomy or creation of ileostomy or colostomy) and frequency of sustained corticosteroid free remission, one of the major outcomes tracked by the ImproveCareNow Network.
Study Period: June 2020-July 2021
Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.
Contact: ImproveCareNow Research
Title: Real-world Evidence for the Effectiveness and Safety of Ustekinumab Treatment in Children with Crohn’s Disease: A Retrospective Cohort Study using the ImproveCareNow Registry Data
PIs:
Steve Steiner, MD, REALITI Co-Principal Investigator, Riley Children’s Hospital
Shehzad Saeed, MD, REALITI Co-Principal Investigator, ImproveCareNow & Dayton Children’s Hospital
Jeremy Adler, MD, REALITI Co- Principal Investigator, University of Michigan – C.S. Mott Children’s Hospital
Purpose: The primary objective of this study is to evaluate the clinical effectiveness of ustekinumab by determining the clinical remission rate in pediatric patients with moderately to severely active Crohn’s Disease (CD) in the ICN registry who were treated with ustekinumab.
Primary Outcome: This study will generate knowledge about the use of ustekinumab in the management of pediatric Crohn’s Disease. The results of this study will be included as part of a Janssen submission to the FDA for the approval of the use of ustekinumab in pediatric patients, as they plan a phase 3 clinical trial of ustekinumab. In addition, the inclusion of RWE from ICN could help facilitate the approval of ustekinumab and other new drugs for IBD, making new IBD treatments accessible to pediatric patients sooner, enabling better outcomes for our patients. If the ICN-Janssen REALITI Study is successful, other new IBD drugs could be studied in a similar way, having a major impact on the health of our patients as well as on the sustainability of ICN.
Funding Source: Janssen has provided funding to ICN to perform this study; however, it is important to note that this is an observational study with a retrospective chart review and not an interventional study.
Study Period: The study will take approximately 9 to 18 months to complete from implementation to publication.
Recruitment Status: All eligible patients have been identified via the ICN Registry, the 72 ICN centers with eligible patients have been invited to participate.
Contact: [email protected]
Principal Investigator: Thierry Dervieux, CSO and Laboratory director, Prometheus Laboratories
Specific Aim:
- The specific aim to establish the association between ADA PK and clinical outcome and disease control from the
Improve Care now data registry. Our hypothesis is that higher Clearance and lower exposure associate with worse
clinical outcomes in pediatric IBD patients receiving ADA, thus delineating a subpopulation of patients that will
benefit from dose intensification.
Study Period: November 2024
Contact: Thierry Dervieux
Purpose: The purpose of this study is to identify the risk factors that are most important in developing severe UC (PUCAI >65 and/or colectomy), so that they can be mitigated and more intensive therapy can be initiated earlier in order to avoid surgery.
Specific Aims:
- Identify risk factors for colectomy and severe disease in UC. Search ICN database to identify patients with UC who required colectomy or had PUCAI>65. Identify top 10 risk factors patients had in common. Compare and contrast risk factors to a case control group of UC patients in the ICN database, marked by physician global assessment “quiescent” and in remission. Check for statistically significant differences among the risk factors between the two groups.
- Identify the medications patients used in each group. Assess statistically if certain medications were used or not by patients who had colectomy or PUCAI > 65.
Contact: Gitit Tomer
Purpose: To determine whether race is associated with delay in diagnosis, patterns of follow-up care, trust in the healthcare system, and key outcomes including use of biologics, steroids, hospitalization and surgery.
We will also test whether socioeconomic status, frequency of follow-up and trust in the healthcare system confound or mediate associations between race and IBD outcomes.
Primary Outcome: Each outcome is selected to understand differences in treatment patterns that are likely to impact the course of IBD, are major events that signify a change in disease course, and/or have been associated with significant adverse outcomes. The following outcomes will be compared between the study groups. They are broken into two categories of outcomes: medication treatment patterns and clinical outcomes.
Funding Source: Centers for Disease Control and Prevention (2018)
Study Period: FY 2019 - FY 2023
Recruitment Status: No longer recruiting participants
Contact: ICN
Purpose: The purpose of this descriptive, correlational study is to examine how sleep disturbance, pain, anxiety, depression, and fatigue/low energy (SPADE) symptoms cluster in adolescents living with IBD. We will also examine whether demographic, clinical, and self-management variables are associated with symptom cluster membership.
Specific Aims:
Aim 1: Examine how SPADE (sleep disturbance, pain, anxiety, depression, and fatigue) symptoms cluster in
adolescents with IBD.
Aim 2: Evaluate associations between symptom cluster membership and demographic, clinical, and self-
management variables in adolescents with IBD. Data will be collected at baseline and at 6 months
post-baseline.
Study Period: The timeline for this study is based on an anticipated start date of April 30, 2022.
Contact: Caeli Malloy
Primary Outcome: The primary aim of this study is to obtain initial psychometric properties of a newly developed measure of perceived barriers towards transition and transfer. There is no currently available measure of transition/transfer barriers, as such this project is exploratory in nature. However, we do hypothesize that the transition barriers measure will be a valid and reliable measure of perceived barriers among youth with IBD and their caregiver.
Study Period: Beginning April 2022
Contact: Michele Maddux, PhD
Principal Investigator: Steven Steiner, MD – Riley Hospital for Children
Purpose:
The selected medication for IBD depends primarily on the severity of active disease, the patient's tolerance, observed clinical response, and cost. Timely access to selected medications is critical to prevent complications from untreated disease such as strictures, infection, or need for surgical intervention. Of the approximately 13 biologics/small molecules approved for adult IBD, only 2 are currently approved in children: infliximab and adalimumab.
Pediatric patients often receive non-FDA approved biologics/small molecules with prior authorization after failing other FDA-approved medications or if they present with severe disease that necessitates urgent use of a non-FDA approved medication.
Aims:
- Identify the number/ percentage of patients who were exposed to a biologic/small molecule without FDA approval
- Identify the number/ percentage of patients who were exposed to specific number of biologic/small molecule without FDA approval (i.e. # exposed to 1 drug, # exposed to 2 drugs, etc.)
- Identify the average age of first exposure to non-FDA approved biologic/small molecule
- Identify the time from diagnosis toto first exposure to non-FDA approved biologic/small molecule (will consider time to second, third exposure as well)
- Identify variations, if any, of non-FDA approved biologic/small molecule medication use within gender and race/ethnicity subgroups
Funding Source (Year Awarded): 2022 - IU Pediatric GI Departmental Funding during fellowship
Study Period: July 2023 – June 2025
Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.
Contact: [email protected]
Purpose: Uveitis has long been recognized as an extraintestinal manifestation of inflammatory bowel disease. The prevalence of uveitis in the pediatric IBD population has only been studied in small groups of IBD patients in single-center studies. Evaluating the prevalence of uveitis in the ImproveCareNow database will allow us to gain a much better appreciation of the prevalence of uveitis in the pediatric IBD population and learn more about possible risk factors.
Primary/Secondary Outcomes:
- Primary Outcome: Assess the prevalence of uveitis in the pediatric IBD population
- Secondary Outcome: Find associated risk factors for uveitis in the pediatric IBD population
Study Period: Patients enrolled between 2006 and 2016
Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.
Contact: Marc E. Schaefer, MD, MPH
Additional Links
Poster - Uveitis in a Multicenter Pediatric IBD Population: Results from the ICN Network