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

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Inflammatory Bowel Diseases

Treatments

Behavioral: Proactive Symptom Monitoring and Care Coordination

Study type

Interventional

Funder types

Other

Identifiers

NCT04796571
HUM00147500

Details and patient eligibility

About

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.

Enrollment

425 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

425 participants in 3 patient groups

Care Coordination Arm
Experimental group
Description:
Patients were assigned an IBD-focused care coordinator who facilitated a symptom-based monitoring algorithm and supported patient navigation to complement usual care.
Treatment:
Behavioral: Proactive Symptom Monitoring and Care Coordination
Usual Care
No Intervention group
Description:
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.
passive control arn
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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