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

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ClinicalTrials.gov Identifier: NCT02791854
Recruitment Status : Enrolling by invitation
First Posted : June 7, 2016
Last Update Posted : June 4, 2021
Sponsor:
Collaborators:
Crohn's and Colitis Foundation
Cedars-Sinai Medical Center
Dartmouth College
Information provided by (Responsible Party):
Corey Siegel, Dartmouth-Hitchcock Medical Center

Brief 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. 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.

Condition or disease
Crohn's Disease Ulcerative Colitis Inflammatory Bowel Diseases

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" 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Improving the Quality of Care for Adults With Inflammatory Bowel Disease
Actual Study Start Date : February 26, 2016
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of patients enrolled [ Time Frame: annually, up to 5 years ]
    count of number of patients consented


Secondary Outcome Measures :
  1. Proportion of patients in remission [ Time Frame: annually, up to 5 years ]
    assessed using a validated disease activity scale

  2. Proportion of patients on steroids [ Time Frame: annually, up to 5 years ]
    assessed by patient report

  3. Proportion of patients admitted into the Emergency Room [ Time Frame: annually, up to 5 years ]
    assessed by patient report

  4. Proportion of patients hospitalized [ Time Frame: annually, up to 5 years ]
    assessed by patient report

  5. Proportion of patients with anemia [ Time Frame: annually, up to 5 years ]
    assessed by patient report and labs

  6. Proportion of patients with malnutrition [ Time Frame: annually, up to 5 years ]
    assessed by patient report and labs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791854


Locations
Show Show 36 study locations
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Crohn's and Colitis Foundation
Cedars-Sinai Medical Center
Dartmouth College
Investigators
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Principal Investigator: Corey Siegel, MD, MS Dartmouth-Hitchcock Medical Center
Principal Investigator: Gil Melmed, MD, MS Cedars-Sinai Medical Center
Additional Information:

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Responsible Party: Corey Siegel, Section Chief, Section of Gastroenterology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02791854    
Other Study ID Numbers: OSP#510516 D16124
Award#P01193 ( Other Identifier: Crohn's and Colitis Foundation )
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases