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 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
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]
Primary Investigator: Malika Goel - UCSF Benioff Children's Hospitals
Hypothesis:
Given genetic and environmental differences, the timing and likelihood of biologic initiation, specific biologics used and the response to IBD treatment will be different in Asian patients as compared to African American / Black patients and White patients.
Specific Aims:
Aim 1) To compare the patterns and treatment variations in biologic therapy use, including a) the time and likelihood of the first biologic initiated within one year of disease diagnosis; b) type of biologic initiated within one year of disease diagnosis; c) changes in biologic treatment, if any, among Asian patients compared with African American/ Black patients and White patients within the one year of disease diagnosis.
Aim 2) To compare the differences in time to change to the second or third biologic among Asian patients compared with African American/Black patients and White patients within the one year of disease diagnosis.
Aim 3) To evaluate differences in remission rates achieved on First biologic therapy initiated between Asian patients compared with African American/Black patients and White patients within one year of disease diagnosis.
Purpose:
There is an urgent need to address mental health comorbidities in youth with Inflammatory Bowel Disease (IBD).
One prevalent and burdensome mental health comorbidity in IBD is Medical Traumatic Stress (MTS), which occurs in about a third of patients. MTS is defined as post traumatic stress symptoms resulting from stressful and potentially traumatic illness-related experiences such as unpredictable hospitalizations and invasive procedures. These symptoms can include a broad range of psychological responses such as flashbacks, nightmares, panic attacks, avoidance of medical visits, and more. It is suggested that MTS has a profound impact on health and quality of life in IBD and other populations. In IBD, MTS has been associated with increased healthcare utilization, worse symptoms and increased disease activity. Despite the knowledge that MTS is prevalent and impactful in youth with IBD, MTS interventions are not a routine part of clinical practice. Addressing this gap is a critical potential pathway to improve outcomes for youth with IBD.
Specific Aims:
Aim 1: Assess the association of patient characteristics with vulnerability to adverse health outcomes from MTS.
Aim 2: Understand barriers and facilitators to the implementation of MTS screening and referral for youth in pediatric IBD clinics.
Aim 3: Develop and pilot a package of implementation strategies for an MTS screening and referral intervention targeting youth in pediatric IBD clinics.
Contact: Addison Cuneo
Principal Investigator: Nicholas Litchin, MD at University of Michigan - C.S. Mott Children's Hospital
Background:
The treatment options for pediatric inflammatory bowel disease includes medical and surgical options. Colectomy is a mainstay of treatment for refractory ulcerative colitis, but the option for colectomy for management of refractory Crohn's disease with colonic involvement that is discussed less often. In the existing literature, there has been limited evaluation of characteristics of pediatric patients with Crohn's disease who undergo colectomy.
Purpose & Aims:
This project seeks to characterize how often pediatric patients with Crohn's disease undergo colectomy, and to better define which pediatric patients wind up having a colectomy and the outcomes for these patients so that more robust conversations can be had about potential surgical intervention at the time of diagnosis for pediatric patients diagnosed with Crohn's colitis. A secondary aim will be to analyze the subgroup of patients who undergo diverting ostomy after colectomy or who require re-diversion after colectomy.
Contact: [email protected]
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 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
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
Principal Investigator: Carmine Suppa - MUSC Children's Hospital
Purpose:
There is an increasing amount of advanced therapeutic use in the treatment of pediatric IBD outside current FDA approval. This included the use of Jak inhibitors despite minimal pediatric data. What is known: jak inhibitors are efficacious in inducing and maintaining remission in adult IBD. Pediatric data remains extremely scarce. This review of the ICN network would provide the community with the largest pediatric numbers to date and ultimately, aid in insurance approvals/appeals and physician comfort with use.
Aims:
Describe jak inhibitor efficacy in the treatment of pediatric IBD. Primary outcome would be steroid free clinical remission at 1 year as defined by PUCAI, PCDAI. Secondary outcomes will include 1 year colectomy rates, clinical remission and response at 8 weeks for UC/IBDU and 12 weeks for CD. We hypothesize that remission and response rates at 1 year is going to be similar to adult literature.
Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.
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]
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
Principal Investigator: Akash Pandey, MD at Arnold Palmer Hospital for Children
Background:
Inflammatory Bowel Disease (IBD) pathogenesis is thought to be influenced by a mix of genetics, intestinal microbiome, immune dysregulation, and environmental exposures(1). IBD may follow a seasonal pattern in its onset and exacerbations. Some studies have reported acute onset of symptoms of Crohn's Disease (CD) more frequently in January and July, whereas Ulcerative Colitis (UC) symptoms were more frequently reported in December(2). However, there are some studies showing conflicting data(3). Globally, a 2022 study looked at the effects of environmental factors such as temperature, weather, and seasons on IBD exacerbations in adults(4). Results of meta-analysis of seven studies showed a non-negligible to weak correlation for seasonal variation and IBD exacerbations, non-negligible to weak correlation within UC, and a weak positive correlation within CD(4). The study was limited by a lack of a clear definition of IBD exacerbation and information on disease location and medication, thereby contributing to the difficulty in interpretation of results(4). Additionally, a multicenter observational study from Japan looked at seasonality and newly diagnosed IBD cases and exacerbations, revealing that CD had higher proportionally diagnosed cases in the summer while UC had no clear association with seasons(5). Winter had the highest exacerbations(5). Interestingly, age appeared to represent an independent risk factor for seasonality and newly diagnosed IBD as well as exacerbations, specifically in patients aged 40 or less(5).
There is limited data in the pediatric population. A single center in Michigan found a seasonal trend in the onset of symptoms of IBD with the highest incidence in the fall and lowest in the summer(2). In 2014, a retrospective study of ImproveCareNow data from December 2008 to November 2010 examined seasonality and IBD and reported that the proportion of UC patients in continuous remission was highest in the summer and lowest in the winter and no significant pattern for CD (6).
At our institution at Arnold Palmer Hospital for Children, we analyzed data on 206 actively enrolled patients in ImproveCareNow from 2014-2024. While our results did not show a statistical difference in new diagnosis of IBD across the year, there were suggestive peaks in January, April, and October, particularly for CD. Overall, these inconsistencies highlight the importance of obtaining larger sample sizes and years of data for analysis. We are requesting access to de-identified ICN multicenter data to evaluate possible patterns in occurrence
of new diagnosis of IBD to be better prepared as clinicians for our patient population. While maintaining remission rates is ideal, we would like to review the months of newly diagnosed pediatric IBD to help clinicians to be more proactive in ordering studies for patients who present with symptoms resembling irritable bowel syndrome that may have early, mild symptoms of IBD that could be overlooked. If we identify certain months with higher IBD diagnoses, we can proactively screen patients. Early detection and intervention can improve the care of those with this lifelong condition and improve quality of life and enhancement of activities of daily living and overall well-being.
Purpose & Aims:
We aim to report the monthly variation in onset of IBD in pediatric patients and determine if this follows a specific pattern throughout the United States with regards to seasonality and geographic location to be better prepared as clinicians for providing care and support.
Contact: [email protected]
References
1. Kucharzik T, Maaser C, Lügering A, et al. Recent understanding of IBD pathogenesis: implications for future therapies. Inflamm Bowel Dis. 2006;12(11):1068-1083. doi:10.1097/01.mib.0000235827.21778.d5
2. Dharmaraj R, Jaber A, Arora R, Hagglund K, Lyons H. Seasonal variations in onset and exacerbation of inflammatory bowel diseases in children. BMC Res Notes. 2015;8:696. Published 2015 Nov 20. doi:10.1186/s13104-015-1702-y
3. Lewis JD, Aberra FN, Lichtenstein GR, Bilker WB, Brensinger C, Strom BL. Seasonal variation in flares of inflammatory bowel disease. Gastroenterology. 2004;126(3):665-673. doi:10.1053/j.gastro.2003.12.003
4. Moon SJ, Lee YC, Kim TJ, Kim K, Son HJ (2022) Effects of temperature, weather, seasons, atmosphere, and climate on the exacerbation of inflammatory bowel diseases: A systematic review and meta-analysis. PLOS ONE 17(12): e0279277. https://doi.org/10.1371/journal.pone.0279277
5. Araki M, Shinzaki S, Yamada T, Arimitsu S, Komori M, Shibukawa N, Mukai A, Nakajima S, Kinoshita K, Kitamura S, Murayama Y, Ogawa H, Yasunaga Y, Oshita M, Fukui H, Masuda E, Tsujii M, Hiyama S, Inoue T, Iijima H, Takehara T. Age at onset is associated with the seasonal pattern of onset and exacerbation in inflammatory bowel disease. J Gastroenterol. 2017 Nov;52(11):1149-1157. doi: 10.1007/s00535-017-1313-6. Epub 2017 Feb 6. PMID: 28168321.
6. Lee, G.J., Dotson, J.L., Kappelman, M.D., King, E., Pratt, J.M., Colletti, R.B., Bistrick, S., Burkam, J.L., Crandall, W.V. and ImproveCareNow Network (2014), Seasonality and Pediatric Inflammatory Bowel Disease. Journal of Pediatric Gastroenterology and Nutrition, 59: 25-28. https://doi.org/10.1097/MPG.0000000000000362
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
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
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
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