N/A N=232 Randomized Prevention

Health IT Generated PROs to Improve Outcomes in Cirrhosis

Cirrhosis

Bottom Line

View on ClinicalTrials.gov: NCT03564626 ↗

Enrolled (actual)

232

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcome: Primary: Avoidable Readmissions — 12; 23 Number of avoidable readmissions

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Health-IT +/- Scheduled Follow Up (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Virginia Commonwealth University
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Avoidable Readmissions	12; 23	—

Summary

SPECIFIC AIM 1: To evaluate in a multi-center, randomized trial the effectiveness of PROs elicited using PatientBuddy and EncephalApp on the prevention of avoidable 30 day readmissions in patients with cirrhosis and their caregivers compared to standard of care.

Eligibility Criteria

Patient Inclusion Criteria:

Cirrhosis patients ≥21 years of age hospitalized for non-elective reasons
Adult caregiver and the patient living in the same house
Able to complete the Patient Buddy training and evaluation
Discharged home from the hospital
Discharge hospital as primary hospital base

Caregiver Inclusion Criteria:

Living in same dwelling as patient for the last ≥1 year
Able to complete the Patient Buddy training and evaluation
Familiar with the patient's routine

Patient Exclusion Criteria:

Elective hospitalization
Lack of an adult caregiver
Active substance abuse within 1 month of the hospitalization (alcohol use is acceptable provided the patient does not have alcoholic hepatitis during this admission or <1 month prior to admission)
Unable to perform training or give consent
Patients discharged to hospice, nursing home or extended care facilities
pregnant women
patients with limited English proficiency

Caregiver Exclusion Criteria

Unable or unwilling to train or adhere to study guidelines
Unfamiliar with the patient routines
Not in the same house as the patient

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03564626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.