Crohn's DiseaseIBD:QORUSNCT02791854
Improving the Quality of Care for Adults With Inflammatory Bowel Disease
An observational study of Crohn's Disease and Ulcerative Colitis, run by Dartmouth-Hitchcock Medical Center at 29 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- How many people
- 10,000 participants
- Where
- 29 sitesUnited States
- Study dates
- 26 Feb 2016to Dec 2030
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent
- Study key personnel cannot enroll as a study participant
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
United States29 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Digestive Health Center
Boise, Idaho, 83704
Saratoga Schenectady Gastroenterology Associates
Burnt Hills, New York, 12027
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22903
University of Chicago Medicine Inflammatory Bowel Disease Center
Chicago, Illinois, 60637
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Colorado Health
Denver, Colorado, 80045
Digestive Care Center
Evansville, Indiana, 47714
Corewell Health
Grand Rapids, Michigan, 49546
Penn State Hershey Inflammatory Bowel Disease Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine IBD Center
Houston, Texas, 77030
Regional GI
Lancaster, Pennsylvania, 17601
Dartmouth-Hitchcock Inflammatory Bowel Disease Center
Lebanon, New Hampshire, 03756
Cedars-Sinai Inflammatory Bowel Disease Center
Los Angeles, California, 90048
Gastro Health LLC
Miami, Florida, 33133
NYU Long Island- Inflammatory Bowel Disease Center
Mineola, New York, 11501
Yale School of Medicine IBD Program
New Haven, Connecticut, 06520
New York University Langone Medical Center
New York, New York, 10016
Weill Cornell Medical College
New York, New York, 10065
Hoag Digestive Health
Newport Beach, California, 92658
The Oregon Clinic - Gastroenterology
Portland, Oregon, 97220
Gastroenterology Associates
Providence, Rhode Island, 02904
University of Rochester
Rochester, New York, 14642
University of Utah Health Care
Salt Lake City, Utah, 84132
UC San Diego Health Inflammatory Bowel Disease Center
San Diego, California, 92037
GastroIntestinal Specialists, A.M.C.
Shreveport, Louisiana, 71115
University of South Florida
Tampa, Florida, 33606
MedStar Georgetown University Hospital Center for Inflammatory Bowel Disease
Washington D.C., District of Columbia, 20007
About this study
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.
Read the 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.
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Registry participant | This is a registry study, the same information is collected from all participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients enrolled
count of number of patients consented
Measured: annually, up to 5 years
Secondary outcomes (6)
Proportion of patients in remission
assessed using a validated disease activity scale
Measured: annually, up to 5 years
Proportion of patients on steroids
assessed by patient report
Measured: annually, up to 5 years
Proportion of patients admitted into the Emergency Room
assessed by patient report
Measured: annually, up to 5 years
Proportion of patients hospitalized
assessed by patient report
Measured: annually, up to 5 years
Proportion of patients with anemia
assessed by patient report and labs
Measured: annually, up to 5 years
Proportion of patients with malnutrition
assessed by patient report and labs
Measured: annually, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start26 Feb 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation, Cedars-Sinai Medical Center, Dartmouth College
- Responsible party
- Principal investigator, Corey Siegel, Dartmouth-Hitchcock Medical Center
- Investigators
- Corey Siegel, MD, MS, Principal investigator, Dartmouth-Hitchcock Medical CenterGil Melmed, MD, MS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791854
- Sponsor's protocol ID
- OSP#510516 D16124
- Other IDs
- Award#P01193
- Acronym
- IBD:QORUS
- Status last verified
- Aug 2025
- First submitted
- 13 May 2016
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Care for Adults With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02791854
- Acronym / sponsor ID
- IBD:QORUS / OSP#510516 D16124
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation, Cedars-Sinai Medical Center, Dartmouth College
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry participant | – | –This is a registry study, the same information is collected from all participants. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Study key personnel cannot enroll as a study participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients enrolled
Time frame: annually, up to 5 years
count of number of patients consented
6 secondary outcomes
Proportion of patients in remission
Time frame: annually, up to 5 years
Proportion of patients on steroids
Time frame: annually, up to 5 years
Proportion of patients admitted into the Emergency Room
Time frame: annually, up to 5 years
Proportion of patients hospitalized
Time frame: annually, up to 5 years
Proportion of patients with anemia
Time frame: annually, up to 5 years
Proportion of patients with malnutrition
Time frame: annually, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corey Siegel, MD, MS principal investigator
Dartmouth-Hitchcock Medical Center
Gil Melmed, MD, MS principal investigator
Cedars-Sinai Medical Center
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Dartmouth-Hitchcock Medical Center at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients enrolled (time frame: annually, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.