Clinical trial NCT02791854: Improving the Quality of Care for Adults With Inflammatory Bowel Disease
Official title: Improving the Quality of Care for Adults With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Diseases
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Foundation
name: Cedars-Sinai Medical Center
name: Dartmouth College
First posted: 2016-06-07
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of patients enrolled
timeFrame: annually, up to 5 years
Secondary outcomes:
measure: Proportion of patients in remission
timeFrame: annually, up to 5 years
measure: Proportion of patients on steroids
timeFrame: annually, up to 5 years
measure: Proportion of patients admitted into the Emergency Room
timeFrame: annually, up to 5 years
measure: Proportion of patients hospitalized
timeFrame: annually, up to 5 years
measure: Proportion of patients with anemia
timeFrame: annually, up to 5 years
measure: Proportion of patients with malnutrition
timeFrame: annually, up to 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center at University of Southern California Digestive Health Center (USC/Keck)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Inflammatory Bowel Disease Center
state: California
city: Newport Beach
country: United States
facility: Hoag Digestive Health
state: California
city: San Diego
country: United States
facility: UC San Diego Health Inflammatory Bowel Disease Center
state: California
city: Denver
country: United States
facility: University of Colorado Health
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine IBD Program
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital Center for Inflammatory Bowel Disease
state: District of Columbia
city: Miami
country: United States
facility: Gastro Health LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Boise
country: United States
facility: Digestive Health Center
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Medicine Inflammatory Bowel Disease Center
state: Illinois
city: Evansville
country: United States
facility: Digestive Care Center
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
city: Shreveport
country: United States
facility: GastroIntestinal Specialists, A.M.C.
state: Louisiana
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Novi
country: United States
facility: The Henry Ford Center for Inflammatory Bowel Disease
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Inflammatory Bowel Disease Center
state: New Hampshire
city: Burnt Hills
country: United States
facility: Saratoga Schenectady Gastroenterology Associates
state: New York
city: Mineola
country: United States
facility: NYU Long Island- Inflammatory Bowel Disease Center
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Portland
country: United States
facility: The Oregon Clinic - Gastroenterology
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Inflammatory Bowel Disease Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Regional GI
state: Pennsylvania
city: Providence
country: United States
facility: Gastroenterology Associates
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine IBD Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Care
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Corey Siegel, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Gil Melmed, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: