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Completed

NCT Number: NCT04796571

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proactive Symptom Monitoring and Care Coordination

Behavioral

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.

Primary outcomes

  1. Change in patient reported outcome (PRO) scores

    Time frame: 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.

  2. IBD-related charges per person

    Time frame: 12 months

    extracted charges where IBD was the primary diagnosis over study period

  3. Total healthcare charges per person

    Time frame: 12 months

    all extracted charges over study period

Secondary outcomes

  1. Emergency Department (ED) visits per person

    Time frame: 12 months

    extracted number of persons experiencing an ED visit over the study period

  2. Proportion of hospitalizations per person

    Time frame: 12 months

    extracted number of persons experiencing hospitalization over the study period

  3. Change in IBD medication utilization

    Time frame: 12 months

    Use of any of the following medications: biologic therapy, immunosuppressant therapy, corticosteroids, narcotics over study period

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Twine Clinical Consulting LLC

Registry information

Acronym: CAPTURE IBD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2021
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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