ImproveCareNow Retrospective_Research


Use of Non-FDA Approved Biologics and Small Molecule Medications in Pediatric Patients with Inflammatory Bowel Disease

A:

Principal Investigator: Steven Steiner, MD – Riley Hospital for Children

Purpose:
The selected medication for IBD depends primarily on the severity of active disease, the patient's tolerance, observed clinical response, and cost. Timely access to selected medications is critical to prevent complications from untreated disease such as strictures, infection, or need for surgical intervention. Of the approximately 13 biologics/small molecules approved for adult IBD, only 2 are currently approved in children: infliximab and adalimumab.

Pediatric patients often receive non-FDA approved biologics/small molecules with prior authorization after failing other FDA-approved medications or if they present with severe disease that necessitates urgent use of a non-FDA approved medication.

Aims:

  1. Identify the number/ percentage of patients who were exposed to a biologic/small molecule without FDA approval
  2. Identify the number/ percentage of patients who were exposed to specific number of biologic/small molecule without FDA approval (i.e. # exposed to 1 drug, # exposed to 2 drugs, etc.)
  3. Identify the average age of first exposure to non-FDA approved biologic/small molecule
  4. Identify the time from diagnosis toto first exposure to non-FDA approved biologic/small molecule (will consider time to second, third exposure as well)
  5. Identify variations, if any, of non-FDA approved biologic/small molecule medication use within gender and race/ethnicity subgroups

Funding Source (Year Awarded): 2022 - IU Pediatric GI Departmental Funding during fellowship

Study Period: July 2023 – June 2025

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

Contact: [email protected] 


Characteristics of pediatric Crohn’s disease patients unable to achieve remission within the first two years of being diagnosed

A:

Purpose: This study aims to determine the predictive variables of pediatric CD patients who do not reach remission within two years of diagnosis. 

Specific Aims: This group of pediatric patients will be compared with CD patients who do go into remission within two years of diagnosis in order to find predictors of (non-) remission, correlations, define 'at risk' patients and asses it’s impact on treatment strategy (drugs, strategy and closer follow-up). 

Study Period: April 2023-December 2024

Contact: Juliette Moreau


Characteristics of pediatric ulcerative colitis patients unable to achieve remission within the first two years of being diagnosed

A:

Purpose: The purpose of this study is to determine the predictive variables for pediatric UC patients who do or do not reach remission within two years of diagnosis

Specific Aims:

This group of pediatric patients will be compared with UC patients who do go into remission within two years of diagnosis in order to find predictors of (non-) remission, correlations, define 'at risk' patients and asses it’s impact on treatment strategy (drugs, strategy and closer follow-up).

Study Period: April 2023-December 2024

Contact: Jonathan Van Hecke


Colectomy: Understanding clinical and variation in care delivery across ICN network

A:

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


A data-driven approach for risk stratification and outcome prediction for PIBD

A:

Purpose: The purpose of this study is to build a risk prediction model for pediatric Crohn's disease to predict outcomes of sustained remission/flare, surgery, and hospitalization using data from ICN Registry and PCORnet.

Specific Aims:

  1. Leveraging longitudinal data from ICN registry and PCORnet, and previously developed methods in assessing and stratifying disease activities, this study proposes to apply data analytics and visualization to facilitate efficient decision support for personalized care and risk prediction in pediatric Crohn’s disease. We aim to develop a machine-learning based clinical pathway learning algorithm for pediatric Crohn’s disease that predicts for 3 outcomes of interests: (1) sustained remission/flare, (2) surgery, and (3) hospitalization. Stratifying patients by their risk levels using PCDAI and sPCDAI, we will infer the common disease progression trajectories that are unique to each patient subpopulation from data, which we further use for prediction of future patient states.

Start Date: March 2017

Contact: Yiye Zhang


Evaluating inequities in personalized care for children with IBD

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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:

  1. Describe variation in the use of anti-TNF therapy and TDM at the patient and practice levels.
  2. 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


Risk Factors associated with colectomy for Ulcerative Colitis

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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


Investigating evaluation and prescribing practices for newly diagnosed inflammatory bowel disease patients during COVID-19

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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


Predictors of Anti-Drug Antibodies and Drug Discontinuation Among Pediatric Patients with Inflammatory Bowel Disease in a Large Learning Health System

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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.
  4. 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


Disparities in height at diagnosis of pediatric IBD

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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


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