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

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Behavioral: Proactive Symptom Monitoring and Care Coordination

• Registration Number: NCT04796571
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-15
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care Coordination Arm	Proactive Symptom Monitoring and Care Coordination	Patients were assigned an IBD-focused care coordinator who facilitated a symptom-based monitoring algorithm and supported patient navigation to complement usual care.

Primary Outcome Measures

Name	Time	Method
IBD-related charges per person	12 months	extracted charges where IBD was the primary diagnosis over study period
Change in patient reported outcome (PRO) scores	9 months	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.
Total healthcare charges per person	12 months	all extracted charges over study period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States