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

• ClinicalTrials.gov Identifier: NCT04796571
• Recruitment Status: Completed
• First Posted: March 15, 2021
• Last Update Posted: March 15, 2021
• Sponsor: University of Michigan
• Collaborator: Twine Clinical Consulting LLC
• Information provided by (Responsible Party): Peter Higgins, University of Michigan

Tracking Information

• First Submitted Date: March 8, 2021
• First Posted Date: March 15, 2021
• Last Update Posted Date: March 15, 2021
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: March 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 11, 2021)

• 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.
• IBD-related charges per person [ Time Frame: 12 months ]
  extracted charges where IBD was the primary diagnosis over study period
• Total healthcare charges per person [ Time Frame: 12 months ]
  all extracted charges over study period

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 11, 2021)

• Emergency Department (ED) visits per person [ Time Frame: 12 months ]
  extracted number of persons experiencing an ED visit over the study period
• Proportion of hospitalizations per person [ Time Frame: 12 months ]
  extracted number of persons experiencing hospitalization over the study period
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients
• Official Title: Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

Blinding of participants was not possible because telephone visits were only offered to participants in the intervention arm. Investigators were blinded to the randomization order, but patients, staff, and providers were not blinded to arm assignment. The investigators who validated the data and performed the data analysis remained blinded to patient group assignment.

Primary Purpose: Supportive Care

• Condition: Inflammatory Bowel 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.

Study Arms

• 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.
  Intervention: Behavioral: Proactive Symptom Monitoring and Care Coordination
• 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.

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 11, 2021): 425
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 1, 2020
• Actual Primary Completion Date: March 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04796571
• Other Study ID Numbers: HUM00147500
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• 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.

• Current Responsible Party: Peter Higgins, University of Michigan
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Michigan
• Original Study Sponsor: Same as current
• Collaborators: Twine Clinical Consulting LLC

Investigators

• Principal Investigator: Peter Higgins, MD, PhD, MSc; University of Michigan

• PRS Account: University of Michigan
• Verification Date: March 2021