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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
425
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.
University of Michigan
Ann Arbor, Michigan, United States
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.
Time frame: 9 months
IBD-related charges per person
extracted charges where IBD was the primary diagnosis over study period
Time frame: 12 months
Total healthcare charges per person
all extracted charges over study period
Time frame: 12 months
Emergency Department (ED) visits per person
extracted number of persons experiencing an ED visit over the study period
Time frame: 12 months
Proportion of hospitalizations per person
extracted number of persons experiencing hospitalization over the study period
Time frame: 12 months
Change in IBD medication utilization
Use of any of the following medications: biologic therapy, immunosuppressant therapy, corticosteroids, narcotics over study period
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Time frame: 12 months