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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-03-01

Brief Summary

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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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Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Proactive Symptom Monitoring and Care Coordination

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No