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

Primary Purpose

Cirrhosis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health-IT +/- Scheduled Follow Up
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic
  • Hunter Holmes McGuire VA Medical Center
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Health IT +/- Scheduled Follow Up

Arm Description

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

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

Outcomes

Primary Outcome Measures

Avoidable readmissions
Study the proportion of avoidable readmissions between groups and between centers

Secondary Outcome Measures

All readmissions
All readmissions that occur between groups and between centers
Readmissions related to hepatic encephalopathy
All hepatic encephalopathy-related readmissions that occur between groups and between centers
Readmissions related to ascites and anasarca
All ascites/anasarca-related readmissions that occur between groups and between centers
Readmissions related to infections
All infection-related readmissions that occur between groups and between centers
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

Full Information

First Posted
June 11, 2018
Last Updated
June 14, 2023
Sponsor
Virginia Commonwealth University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT03564626
Brief Title
Health IT Generated PROs to Improve Outcomes in Cirrhosis
Acronym
HEROIC
Official Title
Health IT Generated PROs to Improve Outcomes in Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 22, 2018 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Arm Title
Health IT +/- Scheduled Follow Up
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Health-IT +/- Scheduled Follow Up
Intervention Description
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 Outcome Measure Information:
Title
Avoidable readmissions
Description
Study the proportion of avoidable readmissions between groups and between centers
Time Frame
30 days
Secondary Outcome Measure Information:
Title
All readmissions
Description
All readmissions that occur between groups and between centers
Time Frame
30 days
Title
Readmissions related to hepatic encephalopathy
Description
All hepatic encephalopathy-related readmissions that occur between groups and between centers
Time Frame
30 days
Title
Readmissions related to ascites and anasarca
Description
All ascites/anasarca-related readmissions that occur between groups and between centers
Time Frame
30 days
Title
Readmissions related to infections
Description
All infection-related readmissions that occur between groups and between centers
Time Frame
30 days
Title
Opinions of patients and caregivers regarding App
Description
Determine usability for patients and caregivers regarding the App, measured by a 0-10 Likert scale with 10 indicating greatest usability
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasmohan S Bajaj, MD
Organizational Affiliation
VCU Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33744844
Citation
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.
Results Reference
derived

Learn more about this trial

Health IT Generated PROs to Improve Outcomes in Cirrhosis

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