Health IT Generated PROs to Improve Outcomes in Cirrhosis

NCT ID: NCT03564626

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-22
• Study Completion Date: 2024-05-22

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.

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.

Conditions

Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Health-IT +/- Scheduled Follow Up

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• 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

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

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jasmohan S Bajaj, MD

Role: PRINCIPAL_INVESTIGATOR

VCU Medical Center

Locations

Mayo Clinic

Rochester, Minnesota, United States

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33744844 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HS025412-01A1

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

HM20003950 multisite extension

Identifier Type: -

Identifier Source: org_study_id