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OpenTrials
Completed

NCT Number: NCT03564626

Health IT Generated PROs to Improve Outcomes in Cirrhosis

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Avoidable Readmissions

    Time frame: 30 days

    Avoidable readmissions within 30 days

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Acronym: HEROIC

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2018
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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