Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients (CAPTURE IBD)

The study team performed a randomized controlled trial to evaluate the efficacy of a care coordination intervention composed of proactive symptom monitoring and algorithm-based triggers to improve patient reported outcomes (PROs) and healthcare expenditures for high-risk patients with IBD. Enrolled patients with IBD were randomized to proactive symptom monitoring with the support of a care coordinator or usual care.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Behavioral: Proactive Symptom Monitoring and Care Coordination

• Study Type: Interventional
• Enrollment (Actual): 425
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• established diagnosis of IBD (with at least 3 office visits)
• followed in GI clinic within 1 year of enrollment
• in top 20th percentile of predicted risk for subsequent healthcare utilization (previously validated model)

Exclusion Criteria:

• non-IBD driver for high utilization (e.g., active cancer undergoing treatment
• A life expectancy of less than one year, were excluded from participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Care Coordination Arm; Patients were assigned an IBD-focused care coordinator who facilitated a symptom-based monitoring algorithm and supported patient navigation to complement usual care.	Behavioral: Proactive Symptom Monitoring and Care Coordination; Patients randomized to the intervention arm were assigned an IBD-focused care coordinator who facilitated a symptom-based monitoring algorithm and supported patient navigation to complement usual care. Symptom monitoring was facilitated through regular push notifications to participants to complete a validated PRO instrument through the Epic EMR patient portal or telephone. These notifications were scheduled on a monthly basis. The IBD-focused care coordinator made two attempts to reach each participant using portal messaging, followed by a phone call to reduce non-response. PRO questionnaires were reviewed by the care coordinator and out of range scores triggered algorithm-based recommendations to the IBD specialist including stricter monitoring of disease activity, behavioral and medication adherence counseling, facilitation of expedited follow-up with treating providers, and referrals to social work, mental health, and gastroenterology-specific behavioral health services.
No Intervention: Usual Care; Participants in the usual care arm underwent symptom monitoring through regular push notifications to participants to complete a validated PRO instrument through the Epic EMR patient portal or telephone. These notifications were scheduled on a monthly basis. Results of the monthly PRO instrument were available to their treating IBD doctor with interventions at their discretion.
No Intervention: passive control arn; To explore whether our usual care arm was influenced by the monthly PRO measurements required for examination of our primary outcome, we compared IBD charges, total charges, ED visits, hospitalizations, and medication utilization at 12 months in the usual care arm to a passive control arm consisting of patients who met eligibility criteria, but were not enrolled in the intervention or usual care arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient reported outcome (PRO) scores	Patient Reported Outcome (PRO) measurements were administered on a monthly basis. The validated Crohn's (CD)-PRO or ulcerative colitis (UC)-PRO were used according to the patient's IBD type (Crohn's or ulcerative colitis). Both the CD-PRO and UC-PRO are a set of standardized and validated instruments based on the Crohn's Disease Activity Index and Mayo Clinic Score respectively, which includes six domains: daily bowel movements, functional symptoms, systemic symptoms, daily coping, weekly life impact, and weekly emotional impact. Scores are calculated a composite score across all domains where a score of 0 represents no symptom activity and a score of 40 represents the highest possible symptom burden. These were not two separate outcomes, rather two independent measurement instruments (scored on the same scale) specific to the patient's IBD-type to address the specific needs/concerns of the patients based on disease type.	9 months
IBD-related charges per person	extracted charges where IBD was the primary diagnosis over study period	12 months
Total healthcare charges per person	all extracted charges over study period	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department (ED) visits per person	extracted number of persons experiencing an ED visit over the study period	12 months
Proportion of hospitalizations per person	extracted number of persons experiencing hospitalization over the study period	12 months
Change in IBD medication utilization	Use of any of the following medications: biologic therapy, immunosuppressant therapy, corticosteroids, narcotics over study period	12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Twine Clinical Consulting LLC
• Investigators: Principal Investigator: Peter Higgins, MD, PhD, MSc, University of Michigan

Publications and helpful links

General Publications

• Berinstein JA, Cohen-Mekelburg SA, Greenberg GM, Wray D, Berry SK, Saini SD, Fendrick AM, Adams MA, Waljee AK, Higgins PDR. A Care Coordination Intervention Improves Symptoms But Not Charges in High-Risk Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):1029-1038.e9. doi: 10.1016/j.cgh.2021.08.034. Epub 2021 Aug 28.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: HUM00147500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share this PHI data with the public, however it there is a request, de-identified data could be arranged.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No