Cirrhosis
Conditions
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.
Interventions
OTHERHealth-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
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Avoidable Readmissions | 30 days | Avoidable readmissions within 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group/ no Dyads 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. No dyads enrolled in this part of the study. Only the patients (subjects) were enrolled in this part of the study, not dyads. The numbers only represent the patient enrollment numbers. | 116 |
| Health IT +/- Scheduled Follow Up/ no Dyads Subjects 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
Health-IT +/- Scheduled Follow Up: -Training patient 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 | 116 |
| Total | 232 |
Baseline characteristics
| Characteristic | Control Group/ no Dyads | Total | Health IT +/- Scheduled Follow Up/ no Dyads |
|---|---|---|---|
| Age, Continuous | 58.42 years STANDARD_DEVIATION 8.89 | 58.8 years STANDARD_DEVIATION 10.6 | 59.1 years STANDARD_DEVIATION 12.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 12 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants | 220 Participants | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 89 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 80 Participants | 143 Participants | 63 Participants |
| Region of Enrollment United States | 116 participants | 232 participants | 116 participants |
| Sex: Female, Male Female | 40 Participants | 98 Participants | 58 Participants |
| Sex: Female, Male Male | 76 Participants | 134 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 116 |
| other Total, other adverse events | 0 / 116 | 0 / 116 |
| serious Total, serious adverse events | 0 / 116 | 0 / 116 |
Outcome results
Primary
Avoidable Readmissions
Avoidable readmissions within 30 days
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group/ No Dyads | Avoidable Readmissions | 12 Number of avoidable readmissions |
| Health IT +/- Scheduled Follow Up/ no Dyads | Avoidable Readmissions | 23 Number of avoidable readmissions |