Health IT Generated PROs to Improve Outcomes in Cirrhosis

Cirrhosis Clinical Trial

— HEROIC  

Official title:

Health IT Generated PROs to Improve Outcomes in Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564626
• Other study ID #: HM20003950 multisite extension
• Secondary ID: 1R01HS025412-01A
• Status: Completed
• Phase: N/A
• Start date: June 22, 2018
• Est. completion date: May 22, 2024

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: May 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Avoidable readmissions	Study the proportion of avoidable readmissions between groups and between centers	30 days
Secondary	All readmissions	All readmissions that occur between groups and between centers	30 days
Secondary	Readmissions related to hepatic encephalopathy	All hepatic encephalopathy-related readmissions that occur between groups and between centers	30 days
Secondary	Readmissions related to ascites and anasarca	All ascites/anasarca-related readmissions that occur between groups and between centers	30 days
Secondary	Readmissions related to infections	All infection-related readmissions that occur between groups and between centers	30 days
Secondary	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	30 days