Inflammatory Bowel Diseases
Conditions
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.
Interventions
BEHAVIORALProactive 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.
Sponsors
Twine Clinical Consulting LLC
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient reported outcome (PRO) scores | 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 | 12 months | extracted charges where IBD was the primary diagnosis over study period |
| Total healthcare charges per person | 12 months | all extracted charges over study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department (ED) visits per person | 12 months | extracted number of persons experiencing an ED visit over the study period |
| Proportion of hospitalizations per person | 12 months | extracted number of persons experiencing hospitalization over the study period |
| Change in IBD medication utilization | 12 months | Use of any of the following medications: biologic therapy, immunosuppressant therapy, corticosteroids, narcotics over study period |
Countries
United States
Outcome results
None listed