Clinical trial NCT03564626: Health IT Generated PROs to Improve Outcomes in Cirrhosis
Official title: Health IT Generated PROs to Improve Outcomes in Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2018-06-21
Enrollment: 464
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Avoidable readmissions
timeFrame: 30 days
Secondary outcomes:
measure: All readmissions
timeFrame: 30 days
measure: Readmissions related to hepatic encephalopathy
timeFrame: 30 days
measure: Readmissions related to ascites and anasarca
timeFrame: 30 days
measure: Readmissions related to infections
timeFrame: 30 days
measure: Opinions of patients and caregivers regarding App
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: VCU Medical Center
name: Jasmohan S Bajaj, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.