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

Inflammatory Bowel Diseases Clinical Trial

— CAPTURE IBD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796571
• Other study ID #: HUM00147500
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Twine Clinical Consulting LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	IBD-related charges per person	extracted charges where IBD was the primary diagnosis over study period	12 months
Primary	Total healthcare charges per person	all extracted charges over study period	12 months
Secondary	Emergency Department (ED) visits per person	extracted number of persons experiencing an ED visit over the study period	12 months
Secondary	Proportion of hospitalizations per person	extracted number of persons experiencing hospitalization over the study period	12 months
Secondary	Change in IBD medication utilization	Use of any of the following medications: biologic therapy, immunosuppressant therapy, corticosteroids, narcotics over study period	12 months