Testing the Impact of Measurement-Based Care on Quality of Life and DiseaseManagement among Veterans with Inflammatory Bowel Disease: A Hybrid Effectiveness-Implementation Study

About This Grant

Background: Inflammatory bowel disease (IBD) is a chronic autoimmune disorder that affects over 60,000 Veterans and leads to highly symptomatic flares and complications. IBD contributes to high health care utilization with the United States spending $25.4 billion annually on IBD-related health care, corresponding to $14,033 per patient each year. Close monitoring and timely treatment adjustment can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for systematic solutions to support close between visit monitoring of Veterans with IBD without which they will continue to experience preventable impairment and disability. Measurement-based care (MBC) is a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC works by facilitating early recognition of clinical deterioration and timely clinician-driven treatment adjustment. MBC also increases patients’ self-efficacy, their confidence in their ability to handle their symptoms and disease. Significance: This study will lay the groundwork for a solution for close monitoring to improve Veterans’ health and meet an important need for tracking patient symptoms, supporting self- management, and facilitating patient-clinician communication at a time when VA is struggling to meet growing demand for specialty services, competing with the private sector to deliver the best possible care for Veterans, and identifying ways to leverage its connected care enterprise. This work addresses 2024 VA priorities to improve access to care, partner with Veterans to improve complex chronic disease care, and understand the value of virtual care technologies. This work also aligns with VA methodologic areas in engagement and implementation science. Innovation & Impact: This work will shift the burden of symptom monitoring away from Veterans, leverage VA-supported MBC tools for longitudinal remote monitoring and be the first test of MBC in IBD in a large integrated health system. Specific Aims: Aim 1 will test the effectiveness of MBC versus E-TAU on key patient outcomes: 1a) IBD-specific patient reported HRQOL (primary outcome) and 1b) IBD-related events obtained via electronic health record data (secondary outcome). The hypothesis is that at 12-month follow-up, Veterans randomized to MBC will have greater improvement in HRQOL and fewer IBD- related events (composite of flares, emergency department visits, hospitalization, surgery) than E-TAU. This hypothesis is supported by the evidence base for MBC in cancer and mental health, and pilot data establishing feasibility and acceptability of MBC in IBD. The rationale is that MBC in IBD enables timely clinician-driven treatment adjustment and promotes patient self-efficacy to reduce symptoms and flares. The study will also explore: 1c) the effect of MBC vs. E-TAU on clinic visits, telephone calls, and gastrointestinal inflammation and 1d) two key mediators (treatment adjustment, self-efficacy) and moderators of intervention effects. Aim 2 will assess determinants of MBC in IBD implementation and acceptability with process evaluation utilizing periodic reflections and semi-structured interviews. Methodology: This project will use a Hybrid Type 1 effectiveness- implementation randomized trial design (n=250 Veterans with IBD) to test the effectiveness of MBC in IBD versus E-TAU on HRQOL and IBD-related events over 12-months and identify barriers and facilitators to MBC in IBD to inform its implementation in practice. Next Steps/Implementation: The long-term goal is to deliver timely and personalized care for Veterans with IBD to improve their HRQOL and reduce health care utilization. This study will inform extension of MBC for other chronic disease populations and future implementation trials.