Background aims: Reducing avoidable readmissions in cirrhosis is challenging. Enhanced engagement using health IT (HIT) interventions and caregivers (CGs) lowered readmissions in an open-label study of the Patient-Buddy App (PBA). Aim: Multi-center trial of PBA versus standard of care (SOC) to reduce avoidable readmissions.
Approach results: An open-label, randomized clinical trial was performed at 3 sites to study the effect of PBA (HIT) versus SOC in cirrhosis inpatients with adult CGs (dyads). Initial randomization was 1:1:1 between SOC, HIT only, and HIT+ visits. However, due to COVID-19, an unplanned study redesign required combined HIT versus SOC. Primary outcome: Avoidable readmissions (decided by a blinded monitoring board). Secondary outcomes were all-cause readmission, and stakeholder input. PBA focused on medication adherence, cognitive testing, and symptoms, and were remotely monitored by study staff. 464 subjects (232 dyads) were enrolled (VCU:120, Mayo:40, VA:72; 116 dyads/group). Avoidable readmissions were significantly higher in SOC vs HIT (19.8% vs. 10.3%, p=0.04) with Odds ratio of 2.14 (95% CI 1.01-4.54) and remained significant even after removing pre-COVID HIT+ Visits patients (19.8% vs. 9.3%, p=0.040) with Odds ratio of 2.41 (95% CI 1.02-5.69). All-cause readmissions were higher in SOC versus HIT (48% vs. 30%, p=0.005). App Evaluation/Engagement: 1660 alerts were sent; mostly related to HE. Most dyads were satisfied with the App.
Conclusion: In a multicenter RCT of 464 cirrhosis inpatients and their caregivers across several practice settings, the Patient Buddy App was associated with lower avoidable readmissions at 30 days post-discharge compared to standard of care.
Keywords: EncephalApp; health Information technology; hepatic encephalopathy; patient buddy app.
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