Improving the Quality of Care for Adults With Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

— IBD:QORUS  

Official title:

Improving the Quality of Care for Adults With Inflammatory Bowel Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02791854
• Other study ID #: OSP#510516 D16124
• Secondary ID: Award#P01193
• Status: Enrolling by invitation
• Start date: February 26, 2016
• Est. completion date: December 2030

Study information

• Verified date: May 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Digestive Health Center	Boise	Idaho
United States	Saratoga Schenectady Gastroenterology Associates	Burnt Hills	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago Medicine Inflammatory Bowel Disease Center	Chicago	Illinois
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Colorado Health	Denver	Colorado
United States	Digestive Care Center	Evansville	Indiana
United States	Gastro One	Germantown	Tennessee
United States	Corewell Health	Grand Rapids	Michigan
United States	Penn State Hershey Inflammatory Bowel Disease Center	Hershey	Pennsylvania
United States	Baylor College of Medicine IBD Center	Houston	Texas
United States	University of Kansas Health System	Kansas City	Kansas
United States	Regional GI	Lancaster	Pennsylvania
United States	Dartmouth-Hitchcock Inflammatory Bowel Disease Center	Lebanon	New Hampshire
United States	Cedars-Sinai Inflammatory Bowel Disease Center	Los Angeles	California
United States	Keck Medical Center at University of Southern California Digestive Health Center (USC/Keck)	Los Angeles	California
United States	Gastro Health LLC	Miami	Florida
United States	NYU Long Island- Inflammatory Bowel Disease Center	Mineola	New York
United States	Yale School of Medicine IBD Program	New Haven	Connecticut
United States	New York University Langone Medical Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Hoag Digestive Health	Newport Beach	California
United States	The Henry Ford Center for Inflammatory Bowel Disease	Novi	Michigan
United States	The Oregon Clinic - Gastroenterology	Portland	Oregon
United States	Gastroenterology Associates	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	University of Utah Health Care	Salt Lake City	Utah
United States	UC San Diego Health Inflammatory Bowel Disease Center	San Diego	California
United States	GastroIntestinal Specialists, A.M.C.	Shreveport	Louisiana
United States	University of South Florida	Tampa	Florida
United States	MedStar Georgetown University Hospital Center for Inflammatory Bowel Disease	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Cedars-Sinai Medical Center, Crohn's and Colitis Foundation, Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients enrolled	count of number of patients consented	annually, up to 5 years
Secondary	Proportion of patients in remission	assessed using a validated disease activity scale	annually, up to 5 years
Secondary	Proportion of patients on steroids	assessed by patient report	annually, up to 5 years
Secondary	Proportion of patients admitted into the Emergency Room	assessed by patient report	annually, up to 5 years
Secondary	Proportion of patients hospitalized	assessed by patient report	annually, up to 5 years
Secondary	Proportion of patients with anemia	assessed by patient report and labs	annually, up to 5 years
Secondary	Proportion of patients with malnutrition	assessed by patient report and labs	annually, up to 5 years