ImproveCareNow is transforming care, health and costs for all children and youth with IBD through continuous improvement, innovation and discovery. Below is a listing of our current research projects.

Interested in conducting research with ImproveCareNow, but not sure where to start?  In March 2016, a total of 164 healthcare professionals, parents, and patients ranked 22 research topics, based on what they believed would result in the greatest improvement in health and well-being for pediatric IBD patients.  See the full list of topics.

Click on a project name to view additional information.

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:

  1. Identify the perception of prevalence of fatigue HCPs have regarding pediatric IBD patents
  2. Identify the way(s) in which HCPs assess for fatigue in pediatric IBD patients
  3. Identify the way(s) in which HCPs intervene related to fatigue in pediatric IBD patients
  4. 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?)
  5. Identify the self-reported fatigue of patients in clinical remission and patients with active disease

Study Period: January 2022-October 2022

Contact: Sabina Ali

Purpose: The purpose of this study is to improve the understanding of how providers collaborate and manage ostomy medical decision-making processes and recommendations for improvement.

Specific Aims:

Aim 1: Assess multidisciplinary provider-reported perspectives, barriers, and recommendations on medical decision-making and education related to ostomy surgery for pediatric patients with IBD.

Aim 2: Assess multidisciplinary providers’ perspectives and recommendations on how specialty services presently collaborate for medical decision-making and education related to ostomy surgery for pediatric patients with IBD

Study Period: Following approval, the entire study is anticipated to take 7 months (12 weeks for focus group recruitment and completion, 4 weeks for survey development, 8 weeks for survey recruitment and completion, 8 weeks for analyses).

Contact: Jennie David, Laura Mackner

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:

  1. 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.
  2. To evaluate long-term clinical outcomes of pediatric patients initiated on an infliximab biosimilars vs the originator.
  3. 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

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

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Purpose: The COMBINE Trial will study if treatment with a single anti-TNF medication (infliximab and adalimumab) or dual therapy that includes methotrexate is more effective in children with moderate to severe Crohn’s disease. COMBINE is the first study to look at this question in children with Crohn’s disease. We expect that 425 kids from across the US will enter the study. The results of this study can be used to help doctors choose medications that help children the most.

Funding Source (Year Awarded): Patient Centered Outcomes Research Institute (2015)

Study Period: 2015-2020

Recruitment Status: Currently recruiting participants 

Contact: Ann Firestine Project Manager, UNC

For more information

COMBINE Trial Website

Care Centers - Find a participating COMBINE center

Clinical Research 101

LOOP blog posts

The COMBINE Study

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Purpose: To characterize current practices surrounding depression screening in pediatric Inflammatory Bowel Disease (IBD) care

Primary Outcome: Clinical practices around depression screening

Study Period: November 2019-February 2020

Recruitment Status: No longer recruiting participants

Contact: Michele Maddux

 

Purpose: The purpose of this study is to develop a model to predict clinical response to and sustained clinical remission following treatment with vedolizumab and ustekinumab in pediatric patients with Ulcerative Colitis (UC) who have previously been exposed to anti-TNF therapy.

Specific Aims:

Objective: To identify baseline predictors of remission and response to vedolizumab and ustekinumab to assist providers in determining therapeutic options in pediatric patients with Ulcerative Colitis who have failed anti-TNF therapy.

Sub Aim 1: Remission rate at 12 weeks, defined as PUCAI < 10.

Sub Aim 2: Response rate at 12 weeks, defined as an improvement in PUCAI > 20.

Sub Aim 3: Sustained remission and response rates at 52 weeks.

Sub Aim 4: Corticosteroid free remission and response rates at weeks 12 and 52.

Study Period: July 2020-July 2022

Contact: Perseus Patel

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Purpose: We intend to use big data and machine learning techniques to improve the models to better predict and maintain response to infliximab therapy.

Primary Outcome: Identify predictors for primary non-response and secondary loss of response.

Secondary Outcome: Determine significant time varying features for effective treatment time.

Funding Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development under award number 5T32HD069054 (Cincinnati Training Program in Pediatric Clinical & Developmental Pharmacology; Vinks, Program director).

Study Period: 2020-2022

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment is occurring at this time.

Contact: Ye Xiong 

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Purpose: When do children and adolescents with inflammatory bowel diseases change diagnoses? Do patients who change diagnoses have different associated outcomes than those who do not experience a change? This study plans to investigate these questions. We think there will be patterns and associations that would interest patients, families, clinicians, researchers, and others interested in improving care for children and adolescents with inflammatory bowel disease.

Primary Outcome: Changing diagnosis

Secondary Outcomes: Medications, hospitalization, surgery types

Study Period: 2019 – 2022

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.

Contact: ImproveCareNow Research

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Purpose: Genotypes that result in deficient activity of the thiopurine-methyltransferase (TPMT) enzyme may confer increased risk of myelosuppression for patients treated with azathioprine. TPMT is essential to the metabolism of azathioprine and is involved in the folic acid metabolism pathway. Therefore, we propose the dietary folic acid supplementation mitigates azathioprine-induced myelosuppression irrespective of TPMT genotype. Hypothesis: Folic acid supplementation mitigates azathioprine-induced myelosuppression in pediatric IBD.

Primary Outcome: 

  • Discern if folic acid supplementation mitigates azathioprine-induced myelosuppression

Secondary Outcome: 

  • Discern how many patients receive folic acid supplementation in addition to azathioprine treatment.
  • Discern the TPMT genotype and phenotype of patients with IBD who develop myelosuppression while on azathioprine

Funding Source: Center for Undergraduate Excellence, Chapman University

Study Period: June 2019- May 2020

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.

Contact: John Miklavcic; (714-516-5520) 

Purpose: The purpose of this study is to evaluate patient characteristics and treatment patterns that may be associated with diagnostic delay.

Specific Aims:

  1. Determine the variation in height z-score at diagnosis
  2. Determine the association between height z-score at diagnosis and socio-demographic information
  3. Determine association between growth stunting at diagnosis and variation in treatment selection and disease outcomes

Contact: Joann Samalik

Specific Aims:

We aim to first determine the disease characteristics and other defining features at diagnosis among a large, multi-center population of pediatric patients with IBDU. We will then evaluate the frequency of diagnostic reclassification to Crohn’s disease or ulcerative colitis over time and assess for characteristics that predict a change in diagnosis. We will evaluate at extent of disease, gender, race, age, anthropometric data, lab data (hematocrit, albumin), and physician global assessment as possible predictors of change in diagnosis. Other secondary outcomes will include change in extent of disease, need for surgery, development of complications (fistula, growth failure, etc).

Study Period: September 2018-August 2023

Contact: Jeremy Adler

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

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Purpose: This study will randomize participants to either eight sessions of online mindfulness-based treatment ("standard") or a briefer, three-session online mindfulness-based treatment ("light") to compare the treatments' efficacy and acceptability across a wide range of conditions and special populations. 

Funding Source: PCORI (2016)

Study Period: May 2016-October 2019

Recruitment Status: No longer recruiting participants

Contact: ImproveCareNow Research 



More information:

PCORI.org - Healthy Mind, Healthy You 

ImproveCareNow Network to Participate in $4 Million Research Study Comparing Stress Management Approaches

 

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Co-Principal Investigators: 

Marc Schaefer, MD, MPH - Penn State Hershey Children’s Hospital

Jeanne Tung, MD - The Children’s Hospital at Oklahoma University

Purpose: Transition of care and transfer of care are two major areas of IBD care that should receive significant attention because they have major potential for quality improvement.  This survey will provide the ICN Transition of Care Task Force with more information about the number of centers providing transition education, the transition tools they are using, and how they are using these tools.  It will also provide us with information on transfer of care, such as what age patients are being transferred and how does the hand-off of clinical information occur at the time of transfer.

Primary/Secondary Outcomes:

  • Primary Outcome: Identify the centers in ImproveCareNow providing transition education
  • Secondary Outcome: Identify the centers in ImproveCareNow that have a transfer process for their patients

Study Period: Survey conducted in the fall of 2015.

Recruitment Status: No longer recruiting participants

Contact: Marc E. Schaefer, MD, MPH

Additional Links

Implementing Transition & Transfer of Care Systems in Pediatric IBD

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: The purpose of this study is to determine what explanatory models are pediatric IBD providers employing when communicating regarding IBD to children.

Specific Aims:

Aim 1: To identify and describe the explanatory models providers use to explain IBD to pediatric patients.

Aim 2: To characterize and explain the explanatory models providers use to explain autoimmunity in IBD.

Aim 3: To characterize the variation in explanatory models for pediatric IBD for patients of varying developmental stages.

Contact: Catalina Berenblum-Tobi

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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

Recruitment Status: Currently recruiting participants

Contact: Study Coordinator, Kimberly Jackson

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

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Purpose: Our goal for this study is to figure out the best way to collect information during a clinic visit about the current symptoms patients are experiencing and then use that information to improve the care patients receive during the visit.

Funding Source (Year Awarded): PCORI (2016)

Study Period: March 2017 – March 2019

Recruitment Status: No longer recruiting participants

Contact: ImproveCareNow Research

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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

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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:

  1. Determine the frequency of biologic drug discontinuation, including associations with patient and practice characteristics, as well as drug dosing and monitoring.
  2. Determine the associations between biologic drug discontinuation and adverse events, evaluation performed prior to drug discontinuation, and barriers to care.
  3. Develop materials and quality improvement processes aimed at reducing biologic drug discontinuation.

Study Period: January 2021-December 2022

Contact: Jeremy Adler

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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 

Purpose: The purpose of this study is to study the proteome that could serve as biomarkers and identify individuals who have IBD or might be at risk for developing IBD.

Specific Aims:

  1. To evaluate the proteome in ten family members in 5 families who have at least 4 affected individuals
  2. To evaluate the genome using the Illumina GSA  chip in the 10 enrolled members of each family

Study Period: January 2019-December 2019

Contact: Harland Winter

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Purpose: The goal of is this study is to better understand the real world experience for the use of vedolizumab in the treatment of pediatric Crohn’s disease

Primary/ Secondary Outcomes

  • Primary Outcome: Clinical remission rates at 1 year
  • Secondary Outcome: Significant baseline factors that predict response to vedolizumab and effect on growth parameters at 1 year

Funding Source: N/A

Study Period:Aug 2020-Jan 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: Jen Savas

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

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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: FY2019 - FY 2023

Recruitment Status: Currently recruiting participants

Contact: Jen Savas

 

Purpose: The purpose of this study is to evaluate knowledge and investigate whether health care providers educate patients about effects of ileal pouch-anal anastomosis (IPAA) surgery (also known as J pouch surgery) on fertility. 

Study Period: March 2021-July 2021

Contact: Rachel Winter

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

Purpose: The purpose of this study is to describe the pediatric IBD population in the ICN database with skin findings of Erythema Nodosum (EN) and Pyoderma Gangrenosum (PG).

Specific Aims:

Primary aims:

--To estimate the incidence of EN and PG in pediatric patients diagnosed with IBD in the database.

--To describe the demographics, disease presentation, natural history and treatments of this patient cohort with both IBD and EN/PG.

Secondary aim:

--To identify factors that may predispose pediatric patients diagnosed with IBD to develop related cutaneous manifestations.

Study Period: The timeline for this study will be approximately 6 to 12 months.

Contact: Brad Pasternak

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

Purpose: The purpose of this study is to determine if there is a difference in clinical remission rates with different treatment regimens in pediatric inflammatory bowel disease BD patients after anti-TNF failure.

Specific Aims:

  1. Compare rates of steroid-free, clinical remission at 52 weeks in pediatric ulcerative colitis patients treated with ustekinumab, vedolizumab, or a second anti-TNF-a medication after treatment failure with one anti-TNF-a
  2. Determine the effect of combination therapy by evaluating rates of steroid-free, clinical remission in pediatric ulcerative colitis patients treated with vedolizumab or ustekinumab with and without an immunomodulator at 52 weeks of treatment.
  3. Evaluate serious infection rates between patients treated with a second anti-TNF-a medication, vedolizumab, and ustekinumab.

Study Period: August 2020-August 2021

Contact: Kimberly Sutton

Purpose: The purpose of this study is to evaluate the decision-making experience of families choosing treatment with ustekinumab for their children with IBD.

Study Period: March 2021-February 2022

Contact: Ellen Lipstein

Purpose: The purpose of this study is to understand pediatric GI providers’ perceptions of and engagement with psychosocial professionals.

Specific Aims:

  • Understand how pediatric GI medical providers think about psychosocial professionals at present in pediatric IBD care
  • Understand how pediatric GI medical providers engage psychosocial professionals at present in pediatric IBD care
  • Identify themes related to perception of and engagement with psychosocial providers across ICN

Study Period: July 2021-October 2021

Contacts: Jennie David, Ellen Sejkora

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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

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Purpose: The severity and extent of ulcerative colitis can vary from limited proctitis (only the rectum) to pancolitis (the entire colon). Adults are more likely to have limited proctitis, while children are more likely to have pancolitis at the time of diagnosis.  Beyond that, little is known about the variation in colitis among different pediatric age groups.  The purpose of this study is to describe the extent of colitis at the time of diagnosis among pediatric patients with ulcerative colitis and indeterminate colitis (also called IBD-U).

Primary/ Secondary Outcomes

  • Primary Outcome: Extent of colitis
  • Secondary Outcome: Other patient characteristics

Funding Source: N/A

Study Period: 2016-2020

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.

Contact: ImproveCareNow Research

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