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: With data from the ImproveCareNow Registry, we aim to determine the trajectory, risk factors, and impact of abdominal pain in youth with IBD during the first year after diagnosis. We hope that findings from this study may inform future screening and intervention approaches for youth with IBD with persistent abdominal pain.

Primary Outcome: Abdominal pain

Study Period: Jan-Dec 2019

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

Contact: ImproveCareNow Research 


Purpose: This study uses data from the ImproveCareNow Registry to examine the duration and effectiveness of Adalimumab therapy in pediatric Crohn’s Disease within the ICN network.  This knowledge is an important step in learning how to optimize the use of Adalimumab.

Funding Source: AbbVie (2016)

Study Period : 2015-2017

Recruitment Status: Recruitment period closed

Contact: ImproveCareNow Research 

More Information:

ImproveCareNow registry used to evaluate use of concomitant immunomodulators with adalimumab therapy in Crohn's Disease

Evaluation of adalimumab effectiveness in anti-tumor necrosis factor-naïve pediatric patients with Crohn's disease in clinical practice

Putting Data to Work to Answer Questions: Evaluation of Adalimumab Effectiveness

Steve Steiner - adalimumbab effectiveness study

Purpose: By using data that exists in the ImproveCareNow Registry, this study aims to measure the duration and effect of adalimumab on clinical outcomes in pediatric ulcerative colitis patients in the clinical practice setting.  This study will add to the knowledge about the use of adalimumab as therapy in the management of pediatric ulcerative colitis.

Funding Source (Year Awarded): AbbVie (2016)

Study Period: 2016-2017

Recruitment Status:  Recruitment period closed

Contact: ImproveCareNow Research

More information:

Evaluation of adalimumab effectiveness in paediatric patients with ulcerative colitis in clinical practice





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


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

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 GROWING study, which stands for Predictors of continued statural GROWth IN older adolescents and younG adults with Crohn’s disease and ulcerative colitis, aims to determine the prevalence of continued growth and to quantify total height gain and height velocity in older adolescents and young adults with Crohn’s disease and ulcerative colitis after the chronological age of expected growth plate closure. We will determine predictors and associative factors of continued growth in these patients.

Funding Source (Year Awarded): Celgene (September 2016)

Study Period: February – December 2017

Recruitment Status: Not recruiting participants

Contact: ImproveCareNow Research 



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: Recruiting (see information below)

Contact: ImproveCareNow Research 


We know that Inflammatory Bowel Disease isn’t easy for people living with it or for their loved ones. Luckily, we know something that might help. Click this link to join a study that explores how mindfulness, a practice of focus and awareness, can reduce stress and negativity for people with more than 100 different medical conditions.

More information: - Healthy Mind, Healthy You 

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

Download flyers to print and share at your ImproveCareNow Center

Sign me up for Healthy Mind, Healthy You


Purpose: This study is investigating whether obesity is associated with worsening disease outcomes in children with Crohn’s disease. In particular, we will be reviewing data from ICN to see if children with newly diagnosed Crohn’s disease had differing Crohn’s disease outcomes at 1 year based on weight status (obese, overweight, normal weight).  The results of this study could help understand whether obesity impacts Crohn’s disease, which could be a potential treatment goal for children.

Primary/Secondary Outcomes:

  • Primary Outcomes: Proportion of children in Crohn’s disease remission at 1 year
  • Secondary Outcomes: Growth, laboratory markers of Crohn’s disease (such as sedimentation rate and blood count), steroid free remission, and disease activity based on objective indices all at 1 year.

Study Period: 2016-2018

Recruitment Status: Not recruiting (reviewing existing children in ICN2 Database)

Contact: Animesh Jain

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: Closed

Contact: Marc E. Schaefer, MD, MPH

Additional Links

Implementing Transition & Transfer of Care Systems in Pediatric IBD

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- June 2020

Recruitment Status: currently recruiting participants

Contact: Study Coordinator, Kimberly Jackson

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 involves secondary data analyses. 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 2019

Recruitment Status: This study involves secondary data analyses. No patient recruitment at this time.

Contact: Ashish Patel 








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: Recruitment period closed

Contact: ImproveCareNow Research








Co- Investigators: David Suskind, MD, Shehzad Saeed, MD & Kimberly Braly, RD

Clinician Stakeholders: Jennifer Burgis, MD & Kaylie Nguyen, PNP

Parent Stakeholders: Sheri Pilley, Julie Stone, Gisele Woodward

Patient Stakeholders: Catalina Berenblum

Project Staff: Sally Pope-Smyth, MPH

Purpose: PRODUCE study, which stands for Personalized Research on Diet in Ulcerative Colitis and Crohn’s Disease, is a first of its kind nutrition intervention study in IBD. With evidence showing dietary intervention has an impact on disease activity for patients with IBD, the PRODUCE study aims to determine the effectiveness of the Specific Carbohydrate Diet (SCD) in reducing symptoms and inflammatory burden in patients with IBD and compare this to a modified form of the SCD. Over the course of this project, a series of N-of-1 studies will be used to examine how the SCD affects individual patients. In addition, we will combine the results of approximately 100 individual N-of-1 studies to look at the effectiveness of the SCD in the pediatric IBD population.

Primary Outcomes: Patient reported outcomes of:

  • Daily stool frequency
  • Daily stool consistency
  • Weekly PROMIS Pain Interference
  • Weekly PROMIS GI symptom severity
  • Fecal calprotectin

Secondary Outcomes: 

  • Short Crohn’s Disease Activity Index (SCDAI)
  • Clinically-evaluated disease activity scores and laboratory markers contained in ICN registry:
    • PUCAI and SPCDAI
    • Growth
    • CRP, HCT, Albumin, ESR
  • Microbiome analyses

Funding Source: Patient Centered Outcomes Research Institute (PCORI; Awarded January 2017)

Study Period: January 2017 – January 2020

Recruitment Status: Recruiting


Heather Kaplan, MD, MSCE - Co-PI

Lisa Opipari-Arrigan, PhD - Co-PI

Sally Pope-Smyth- Clinical Research Coordinator  

Cassandra Dodds - Clinical Research Coordinator 

Lauren Murphy - Clinical Research Coordinator 

For More information:
Care Centers - Find a participating PRODUCE Center 
Blog posts


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: Closed

Contact: Marc E. Schaefer, MD, MPH

Additional Links

Poster - Uveitis in a Multicenter Pediatric IBD Population: Results from the ICN Network


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: 2016-2019

Recruitment Status: This study involves secondary data analyses. No patient recruitment at this time.

Contact: ImproveCareNow Research

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