A pragmatic RCT to evaluate the effect of CirrhosisRx, a novel clinical decision support system, versus usual care on guideline-adherence and clinical outcomes for patients with cirrhosis

NIH RePORTER · NIH · K23 · $189,812 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY Each year, there over 200,000 hospitalizations for cirrhosis in the United States. Over one-third of these patients are readmitted within 30 days, and up to 10% will die in the hospital. Despite national quality measures and care guidelines, cirrhosis care remains suboptimal and highly variable. Clinical Decision Support (CDS) systems present an attractive strategy to improve guideline-adherence due to low implementation costs. These systems, however, remain largely untested in cirrhosis care and it remains unknown whether they are effective at improving guideline-adherence and whether improving guideline-adherence changes clinical outcomes in cirrhosis care. This proposal will leverage my ongoing KL2 work in which I designed “CirrhosisRx,” a cirrhosis-specific CDS system, to address these evidence gaps by: Comparing the effect of CirrhosisRx versus “usual care” on adherence to quality measures and clinical outcomes through a pragmatic randomized controlled trial (pRCT, Aim 1); Assessing whether changes in guideline-adherence mediate changes in outcomes (Sub-Aim 1); Studying CirrhosisRx's reach, adoption, and maintenance in care workflows (Aim 2); and Identifying facilitators and barriers to adopting electronic interventions for cirrhosis care at other centers (Aim 3). These aims will generate the necessary data and knowledge for a future multicenter pRCT of CirrhosisRx and other electronic interventions in hepatology care. I am an Assistant Professor of Medicine at the University of California, San Francisco (UCSF). Building upon a strong foundation of research support, this K23 will allow me to transition from being a retrospective researcher to a pragmatic trialist of electronic interventions in hepatology. I need dedicated training to gain expertise in the conduct, analysis, and dissemination of pRCTs of electronic interventions. Under the supervision of a multidisciplinary team of leaders in hepatology (Lai), clinical informatics (Pletcher), biostatistics (Huang), and implementation sciences and qualitative methods (Ackerman), I will execute a detailed career development plan outlined in this proposal to develop the following skills: 1) pRCT design and conduct, 2) Advanced statistical methods in pRCT data analysis, 3) Intervention evaluation frameworks, and 4) Multicenter collaborations. As part of my 4-year plan, I will actively engage in coursework and structured tutorials in the topics above, and in interdisciplinary development and leadership programs. RELEVANCE: Conducting a pragmatic randomized controlled trial of a cirrhosis-specific clinical decision support system to improve guideline-adherence and clinical outcomes will help provide evidence regarding to the effectiveness of such interventions and allow for the design and execution of future trials of similar interventions to improve cirrhosis care.

Key facts

NIH application ID
10866265
Project number
1K23DK139455-01
Recipient
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
Principal Investigator
Jin Ge
Activity code
K23
Funding institute
NIH
Fiscal year
2024
Award amount
$189,812
Award type
1
Project period
2024-07-01 → 2028-05-31