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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)

Primary Purpose

Inflammatory Bowel Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive Symptom Monitoring and Care Coordination
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Care Coordination Arm

Usual Care

passive control arn

Arm Description

Patients were assigned an IBD-focused care coordinator who facilitated a symptom-based monitoring algorithm and supported patient navigation to complement 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.

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.

Outcomes

Primary Outcome Measures

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.
IBD-related charges per person
extracted charges where IBD was the primary diagnosis over study period
Total healthcare charges per person
all extracted charges over study period

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2021
Last Updated
March 11, 2021
Sponsor
University of Michigan
Collaborators
Twine Clinical Consulting LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04796571
Brief Title
Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Twine Clinical Consulting LLC

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
425 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care Coordination Arm
Arm Type
Experimental
Arm Description
Patients were assigned an IBD-focused care coordinator who facilitated a symptom-based monitoring algorithm and supported patient navigation to complement usual care.
Arm Title
Usual Care
Arm Type
No Intervention
Arm 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.
Arm Title
passive control arn
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Proactive Symptom Monitoring and Care Coordination
Intervention Description
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 Outcome Measure Information:
Title
Change in patient reported outcome (PRO) scores
Description
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.
Time Frame
9 months
Title
IBD-related charges per person
Description
extracted charges where IBD was the primary diagnosis over study period
Time Frame
12 months
Title
Total healthcare charges per person
Description
all extracted charges over study period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Emergency Department (ED) visits per person
Description
extracted number of persons experiencing an ED visit over the study period
Time Frame
12 months
Title
Proportion of hospitalizations per person
Description
extracted number of persons experiencing hospitalization over the study period
Time Frame
12 months
Title
Change in IBD medication utilization
Description
Use of any of the following medications: biologic therapy, immunosuppressant therapy, corticosteroids, narcotics over study period
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Higgins, MD, PhD, MSc
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
34461298
Citation
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.
Results Reference
derived

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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

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