CirrhosisHEROICNCT03564626
Health IT Generated PROs to Improve Outcomes in Cirrhosis
A study testing Health-IT +/- Scheduled Follow Up in people with Cirrhosis, run by Virginia Commonwealth University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Health-IT +/- Scheduled Follow Up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jun 2018to 22 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
Read the 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
- Being tested
- Health-IT +/- Scheduled Follow Up
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-IT +/- Scheduled Follow UpOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Health-IT +/- Scheduled Follow Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoidable Readmissions
Avoidable readmissions within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start22 Jun 2018
- Primary completion22 Apr 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Jasmohan S Bajaj, MD, Principal investigator, VCU Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564626
- Sponsor's protocol ID
- HM20003950 multisite extension
- Other IDs
- 1R01HS025412-01A1
- Acronym
- HEROIC
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2018
- Last updated
- 17 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33744844
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health IT Generated PROs to Improve Outcomes in Cirrhosis
- ClinicalTrials.gov ID
- NCT03564626
- Acronym / sponsor ID
- HEROIC / HM20003950 multisite extension
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Posted 17 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Health-IT +/- Scheduled Follow UpSubjects 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Health IT +/- Scheduled Follow Up |
Primary outcome
Avoidable Readmissions
Time frame: 30 days
Avoidable readmissions within 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33744844Acharya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasmohan S Bajaj, MD principal investigator
VCU Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-IT +/- Scheduled Follow Up in people with Cirrhosis, run by Virginia Commonwealth University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Avoidable Readmissions (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.