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
Additional links
Research Explained - on LOOP
Purpose: The purpose of this study is to evaluate pediatric GI providers' practices and attitudes toward use of mind body interventions (MBI) for patients with inflammatory bowel disease (IBD)?
Specific Aims:
1) Examine pediatric GI providers’ attitudes and perceptions towards MBI as adjunct therapy for pediatric IBD
2) Identify barriers to recommendation of MBI
3) Assess need for further training in MBI for pediatric GI providers
4) Determine if there are differences in practices based on demographic variables (e.g., provider type, age and geographic location of practice)
Start Date: September 2017
Contact: Ann Ming Yeh
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
Study Authors: Jennie G David, PhD, Douglas Chute, PhD, Bonney Reed, PhD, Shehzad Saeed, MD, David DeMatteo, JD, PhD, Orhan Atay, MD, Michele Maddux, PhD, Brian Daly, PhD
Study Period: 2017-2021
Additional links
Study Authors: Moses J, Sandberg K, Winberry G, Riera D, DeLozier S, Gupta SK, Reilly N, Park KT, Picoraro J.
Purpose: Endoscopic remission has become a standard treatment target in inflammatory bowel disease (IBD). It is unclear how widely this practice has been adopted amongst pediatric gastroenterology providers. This study determines the frequency of repeat endoscopy in pediatric IBD and evaluates for predictive baseline characteristics of providers.
Study Period: Dec 2019-Dec 2020
Publication: Moses J, Sandberg K, Winberry G, Riera D, DeLozier S, Gupta SK, Reilly N, Park KT, Picoraro J. Clinical Practice Survey of Repeat Endoscopy in Pediatric Inflammatory Bowel Disease in North America. J Pediatr Gastroenterol Nutr. 2021 Feb 24. doi: 10.1097/MPG.0000000000003100. Epub ahead of print. PMID: 33633082.
Contact: ImproveCareNow Research
Additional links
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: Complete - Manuscript published April 2023 in Gastroenterology
For more information
Researchers Announce Findings from Landmark Clinical Trial for Pediatric Crohn's Disease - UNC Health
ICN Posts
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: 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
Contact: John Miklavcic; (714-516-5520)
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: This study makes use of existing data in the ICN registry.
Contact: ImproveCareNow Research
More Information:
Putting Data to Work to Answer Questions: Evaluation of Adalimumab Effectiveness
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: This study makes use of existing data in the ICN registry.
Contact: ImproveCareNow Research
More information:
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: No longer recruiting participants
Publication:
Gupta N, Liu C, King E, Sylvester F, Lee D, Boyle B, Trauernicht A, Chen S, Colletti R, ImproveCareNow Network . Continued statural growth in older adolescents and young adults with Crohn's disease and ulcerative colitis beyond the time of expected growth plate closure. Inflamm Bowel Dis 2020
Determined the frequency of continued growth and compared the total height gain beyond the time of expected growth plate closure and the chronological age at achievement of final adult height in Crohn's disease (CD) vs ulcerative colitis (UC) and described height velocity curves in inflammatory bowel disease (IBD) compared with children in the National Health and Nutrition Examination Survey (NHANES).
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
More information:
PCORI.org - 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.
Contact: Animesh Jain
Implementing Transition of Care and Transfer of Care Systems in Pediatric Inflammatory Bowel Disease
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.
Contact: Marc E. Schaefer, MD, MPH
Additional Links
Implementing Transition & Transfer of Care Systems in Pediatric IBD
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
Additional Links:
Medical Student and Professor with Inflammatory Bowel Disease Join Forces to Help Pediatricians Understand the Power of Words Article from UNC Health
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
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
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
Contact:
Heather Kaplan, MD, MSCE - Co-PI
Lisa Opipari-Arrigan, PhD - Co-PI
Cassandra Dodds - Clinical Research Coordinator
Lauren Murphy - Clinical Research Coordinator
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:
- To evaluate the proteome in ten family members in 5 families who have at least 4 affected individuals
- 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
Study Authors: Kandavel, Prashanthi; Eder, Sally J.; Adler, Jeremy
Study Period: 2018-2020
Additional links
Research Explained on LOOP
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
Study Authors: , , , et al.
Purpose: This paper, written by patients and providers from ICN, reviews current ICN data on PAC‐generated resources, including creation processes and download statistics.
Study Period: Jul 2020-Feb 2021
Publication: David, J, Berenblum Tobi, C, Kennedy, S, et al. Sustainable generation of patient‐led resources in a learning health system. Learn Health Sys. 2021;e10260. https://doi.org/10.1002/lrh2.10260
Contact: ImproveCareNow Research
Additional links
Research Explained on LOOP
Sustainable generation of patient‐led resources in a learning health system
Study Authors: Miller TL, Schuchard J, Carle AC, Forrest CB, Kappelman MD; COMBINE Study Group
Additional links
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
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
Additional Links:
Objectives: Vedolizumab (VDZ) and ustekinumab (UST) are second-line treatments in pediatric patients with ulcerative colitis (UC) refractory to antitumor necrosis factor (anti-TNF) therapy. Pediatric studies comparing the effectiveness of these medications are lacking. Using a registry from ImproveCareNow (ICN), a global research network in pediatric inflammatory bowel disease, we compared the effectiveness of UST and VDZ in anti-TNF refractory UC.
Study Period: April 2021 - March 2024
Study Author: Perseus Patel