Improving the Quality of Care for Adults With Inflammatory Bowel Disease (IBD:QORUS)

Innovative programs exist that suggest that care for people with chronic conditions is optimized when patients and providers have the information they need at the point of care and over time, to engage in shared planning and execution of treatment goals and care plans. This project aims to build an Inflammatory Bowel Disease Learning Health System, a shared information environment, that highlights collaboration among patients, clinicians and care team members, and researchers; for effective use of data for guiding care, value, improvement, and research.

Study Overview

• Status: Enrolling by invitation
• Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis

Detailed Description

To demonstrate the impact of an Adult Inflammatory Bowel Disease (IBD) Learning Health System approach the study collaborators will design, build, implement, and evaluate in up to 90 IBD care sites the the following four key components of the IBD Learning Health System: 1) a Health Information Technology (HIT) environment that can "feed-forward" Patient Reported Outcomes (PROs) and clinical data to be used at the point of care and integrated into a registry (IBD Plexus); 2) decision-support dashboards for use by patients and clinicians in real time to coproduce care; 3) meaningful reports for patients and clinicians; and 4) multi-stakeholder collaborative networks for improvement and research.

Prior work from Sweden and the US show that successful uptake of the model can offer important benefits. Patients will be able to use web-based tools to monitor their health and manage their care, securely share data with clinicians in a timely manner, visualize outcomes that matter to them, and compare their results to other people. Clinicians will have new information that can improve their ability to track patient outcomes and costs over time; use PRO data to support pre-visit planning, shared decision-making at the point of care, and post-visit monitoring; and receive comparative performance reports to support quality improvement, public reporting, and professional development. Researchers will benefit by having PROs and cost data added to data registries to support clinical, translational, and comparative effectiveness research.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center at University of Southern California Digestive Health Center (USC/Keck)
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Inflammatory Bowel Disease Center
    • Newport Beach, California, United States, 92658
      • Hoag Digestive Health
    • San Diego, California, United States, 92037
      • UC San Diego Health Inflammatory Bowel Disease Center
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Health
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale School of Medicine IBD Program
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital Center for Inflammatory Bowel Disease
  • Florida
    • Miami, Florida, United States, 33133
      • Gastro Health LLC
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
  • Idaho
    • Boise, Idaho, United States, 83704
      • Digestive Health Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine Inflammatory Bowel Disease Center
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Digestive Care Center
  • Kansas
    • Kansas City, Kansas, United States, 66045
      • University of Kansas Health System
  • Louisiana
    • Shreveport, Louisiana, United States, 71115
      • GastroIntestinal Specialists, A.M.C.
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Corewell Health
    • Novi, Michigan, United States, 48377
      • The Henry Ford Center for Inflammatory Bowel Disease
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Inflammatory Bowel Disease Center
  • New York
    • Burnt Hills, New York, United States, 12027
      • Saratoga Schenectady Gastroenterology Associates
    • Mineola, New York, United States, 11501
      • NYU Long Island- Inflammatory Bowel Disease Center
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Oregon
    • Portland, Oregon, United States, 97220
      • The Oregon Clinic - Gastroenterology
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Inflammatory Bowel Disease Center
    • Lancaster, Pennsylvania, United States, 17601
      • Regional GI
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Gastroenterology Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine IBD Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Care
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

In order to participate in IBD Qorus, individuals must meet the following criteria:

• 18 years of age or older
• Diagnosis of Crohn's disease or ulcerative colitis or IBD unclassified
• Accept the terms and conditions of Informed Consent and Authorization
• Affiliated with a participating IBD Qorus site

Description

Inclusion Criteria:

• 18 years of age or older
• Diagnosis of Crohn's disease or ulcerative colitis or IBD unclassified
• Accept the terms and conditions of Informed Consent and Authorization
• Affiliated with a participating IBD Qorus site

Exclusion Criteria:

• Inability to provide informed consent
• Study key personnel cannot enroll as a study participant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Registry participant; This is a registry study, the same information is collected from all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients enrolled	count of number of patients consented	annually, up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients in remission	assessed using a validated disease activity scale	annually, up to 5 years
Proportion of patients on steroids	assessed by patient report	annually, up to 5 years
Proportion of patients admitted into the Emergency Room	assessed by patient report	annually, up to 5 years
Proportion of patients hospitalized	assessed by patient report	annually, up to 5 years
Proportion of patients with anemia	assessed by patient report and labs	annually, up to 5 years
Proportion of patients with malnutrition	assessed by patient report and labs	annually, up to 5 years

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Cedars-Sinai Medical Center; Dartmouth College; Crohn's and Colitis Foundation
• Investigators: Principal Investigator: Corey Siegel, MD, MS, Dartmouth-Hitchcock Medical Center; Principal Investigator: Gil Melmed, MD, MS, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimated): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: OSP#510516 D16124; Award#P01193 (Other Identifier: Crohn's and Colitis Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED