Health IT Generated PROs to Improve Outcomes in Cirrhosis



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:21 - Any
Updated:7/5/2018
Start Date:June 22, 2018
End Date:July 20, 2022
Contact:Jasmohan S Bajaj, MD
Email:jsbajaj@vcu.edu
Phone:8046755021

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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.

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.

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 alcohol/substance abuse within 1 month of the hospitalization

- Unable to perform training or give consent

- Patients discharged to hospice, nursing home or extended care facilities

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
We found this trial at
3
sites
Richmond, Virginia 23249
Phone: 804-675-5021
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Jasmohan S Bajaj, MD, MSc
Phone: 804-828-9780
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Rochester, Minnesota 55905
Principal Investigator: Patrick Kamath, MD
Phone: 507-284-2511
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Rochester, MN
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