Health IT Generated PROs to Improve Outcomes in Cirrhosis (HEROIC)

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Other: Health-IT +/- Scheduled Follow Up

Detailed Description

Cirrhosis affects more than 6 million US patients and is a major burden on patients, caregivers and the healthcare system. Patients with cirrhosis are prone to clinical and psycho-social issues that may predict hospitalization, re-hospitalizations and death. Important patient-reported outcomes (PRO) such as impaired daily functioning, sleep, cognition and pain are widely prevalent in patients with cirrhosis. These changes can independently impact hospitalizations, re-hospitalizations and death in cirrhotic patients. The investigators have studied the impact of these PRO using traditional and computerized scales such as PROMIS (Patient-reported outcomes measurement information system). With the increasing spread of health-related electronic devices, the relevance of health IT in the management of chronic diseases such as cirrhosis is paramount. The team has already developed and used several health IT advances to educate patients and their caregivers in inpatient and outpatient settings. These tools are Patient Buddy to define patients regarding factor preventing readmission, and EncephalApp Stroop to detect cognitive dysfunction in cirrhosis. As part of a funded AHRQ R21, PatientBuddy, which has undergone multiple refinements in response to feedback from patients, caregivers and administering staff, is being used by the study team to prevent readmissions to Virginia Commonwealth University Medical Center (VCU). However the evaluation of these tools in a multi-center study that adapts to the status of the patients and their caregivers is an important step towards improvement in cirrhosis-related outcomes. In addition, PROs that are elicited and monitored when the patients are outside the hospital will advance the field by making them integral parts of clinical management.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Standard of care counseling and discharge instructions per local hospital policy. Standard of care follow up phone calls and visits at baseline and at 30 days. Follow-up will be for 30 days
Experimental: Health IT +/- Scheduled Follow Up; Subjects and caregivers will be given individual phones loaded with the Patient Buddy App and the EncephalApp that will be used to enter medications, issues and orientation questions daily. There will be messages and phone calls as needed per the App and visits will be at baseline, scheduled at 15 days and at 30 days. In addition, scheduled phone calls will be performed at days 7 and 21.Follow-up will be for 30 days	Other: Health-IT +/- Scheduled Follow Up; Training patient and caregiver on Patient Buddy and EncephalApp; Counseling regarding readmission; Daily contact through app; Standard of care counseling regarding readmission and discharge instructions; Follow up phone calls at Week 1 and Week 3; In-person follow up visits at Week 2 and Week 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Avoidable Readmissions	Avoidable readmissions within 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All readmissions	All readmissions that occur between groups and between centers	30 days
Readmissions related to hepatic encephalopathy	All hepatic encephalopathy-related readmissions that occur between groups and between centers	30 days
Readmissions related to ascites and anasarca	All ascites/anasarca-related readmissions that occur between groups and between centers	30 days
Readmissions related to infections	All infection-related readmissions that occur between groups and between centers	30 days
Opinions of patients and caregivers regarding App	Determine usability for patients and caregivers regarding the App, measured by a 0-10 Likert scale with 10 indicating greatest usability	30 days

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Jasmohan S Bajaj, MD, VCU Medical Center

Publications and helpful links

General Publications

• Acharya C, Sehrawat TS, McGuire DB, Shaw J, Fagan A, McGeorge S, Olofson A, White MB, Gavis E, Kamath PS, Bergstrom L, Bajaj JS. Perspectives of Inpatients With Cirrhosis and Caregivers on Using Health Information Technology: Cross-sectional Multicenter Study. J Med Internet Res. 2021 Apr 9;23(4):e24639. doi: 10.2196/24639.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Actual): April 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis
• Other Study ID Numbers: HM20003950 multisite extension; 1R01HS025412-01A1 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No