Improving the Quality of Care for Adults With Inflammatory Bowel Disease

NCT ID: NCT02791854

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-26

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Crohn's Disease Ulcerative Colitis Inflammatory Bowel Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Registry participant

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No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Crohn's and Colitis Foundation

OTHER

Sponsor Role collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role collaborator

Dartmouth College

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Corey Siegel

Section Chief, Section of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Corey Siegel, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Gil Melmed, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Inflammatory Bowel Disease Center

Los Angeles, California, United States

Site Status

Hoag Digestive Health

Newport Beach, California, United States

Site Status

UC San Diego Health Inflammatory Bowel Disease Center

San Diego, California, United States

Site Status

University of Colorado Health

Denver, Colorado, United States

Site Status

Yale School of Medicine IBD Program

New Haven, Connecticut, United States

Site Status

MedStar Georgetown University Hospital Center for Inflammatory Bowel Disease

Washington D.C., District of Columbia, United States

Site Status

Gastro Health LLC

Miami, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Site Status

Digestive Health Center

Boise, Idaho, United States

Site Status

University of Chicago Medicine Inflammatory Bowel Disease Center

Chicago, Illinois, United States

Site Status

Digestive Care Center

Evansville, Indiana, United States

Site Status

GastroIntestinal Specialists, A.M.C.

Shreveport, Louisiana, United States

Site Status

Corewell Health

Grand Rapids, Michigan, United States

Site Status

Dartmouth-Hitchcock Inflammatory Bowel Disease Center

Lebanon, New Hampshire, United States

Site Status

Saratoga Schenectady Gastroenterology Associates

Burnt Hills, New York, United States

Site Status

NYU Long Island- Inflammatory Bowel Disease Center

Mineola, New York, United States

Site Status

New York University Langone Medical Center

New York, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

The Oregon Clinic - Gastroenterology

Portland, Oregon, United States

Site Status

Penn State Hershey Inflammatory Bowel Disease Center

Hershey, Pennsylvania, United States

Site Status

Regional GI

Lancaster, Pennsylvania, United States

Site Status

Gastroenterology Associates

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Baylor College of Medicine IBD Center

Houston, Texas, United States

Site Status

University of Utah Health Care

Salt Lake City, Utah, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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Award#P01193

Identifier Type: OTHER

Identifier Source: secondary_id

OSP#510516 D16124

Identifier Type: -

Identifier Source: org_study_id

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