Health IT Generated PROs to Improve Outcomes in Cirrhosis

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Other: Health-IT +/- Scheduled Follow Up

• Registration Number: NCT03564626
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Study Start: 2018-06-22
• Primary Completion: 2024-04-22
• Study Completion: 2024-05-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health IT +/- Scheduled Follow Up	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

Primary Outcome Measures

Name	Time	Method
Avoidable readmissions	30 days	Study the proportion of avoidable readmissions between groups and between centers

Secondary Outcome Measures

Name	Time	Method
All readmissions	30 days	All readmissions that occur between groups and between centers
Readmissions related to ascites and anasarca	30 days	All ascites/anasarca-related readmissions that occur between groups and between centers
Readmissions related to infections	30 days	All infection-related readmissions that occur between groups and between centers
Opinions of patients and caregivers regarding App	30 days	Determine usability for patients and caregivers regarding the App, measured by a 0-10 Likert scale with 10 indicating greatest usability
Readmissions related to hepatic encephalopathy	30 days	All hepatic encephalopathy-related readmissions that occur between groups and between centers

Trial Locations

Locations (3)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Hunter Holmes McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States