Health IT Generated PROs to Improve Outcomes in Cirrhosis

NCT03564626 | Completed Results

• 2 other identifiers: HM20003950 multisite extension1R01HS025412-01A1
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Avoidable Readmissions

  Avoidable readmissions within 30 days

  30 days

Study Arms (2)

Control Group

NO INTERVENTION

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

Health IT +/- Scheduled Follow Up

EXPERIMENTAL

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

Interventions

Health-IT +/- Scheduled Follow Up OTHER

* 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

Health IT +/- Scheduled Follow Up

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 33744844 DERIVED

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jasmohan Bajaj
• Organization: Virginia Commonwealth University

jasmohan.bajaj@vcuhealth.org

(804) 828-4060

Study Officials

• Jasmohan S Bajaj, MD

  VCU Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: June 22, 2018
• Primary Completion: April 22, 2024
• Study Completion: May 22, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)