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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients using a patient and caregiver perspective.
Specific aim 1: To perform a pilot and feasibility study of disseminating current knowledge of readmission prevention in cirrhosis by using the Patient Buddy App with patient and caregiver interfaces. Eighty subjects (40 cirrhotic inpatients and 40 caregivers) will be enrolled and trained on the Patient Buddy at discharge. The App focuses on daily communication between patient/caregivers and the study team based on previously identified risk factors associated with readmission. The study team will initiate measures to prevent readmission using these communications. A detailed analysis of 30-day readmissions and input of the patients,caregivers and nurse manager will be performed to improve the App. Avoidable readmissions will be defined by a committee of hepatologists who is not part of the study at VCU.
Specific aim 2: To incorporate the opinion of key stakeholders (patients, caregivers and case managers) towards improving the Patient Buddy App in the prevention of avoidable readmission in cirrhosis. The input of the key stakeholders and the analysis of readmissions prevented during the pilot study will be used to update the App for preventing avoidable readmissions in future studies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Buddy | Subjects and caregivers will be given iphones loaded with the App that will be used to enter medications, issues and orientation questions. They will be seen at day 15 and day 30 and will receive a phone call day 7 and day 21 inquiring about issues that would need medical attention |
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| Measure | Description | Time Frame |
|---|---|---|
| Avoidable Readmission | Avoidable Readmissions within 30 days. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Cirrhotic subjects who are hospitalized for non-elective reasons
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| Name | Affiliation | Role |
|---|---|---|
| Jasmohan S Bajaj, MD | VCU Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Buddy Subject Only/Not Dyad | 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. Patients were given iphones loaded with the Buddy App that was used to enter medications, issues and orientation questions. They were seen at day 15 and day 30 and received a phone call day 7 and day 21 inquiring about issues that would need medical attention. |
| FG001 | Standard of Care Subject Only/Not Dyad | No dyads enrolled in this part of the study. Subjects randomized to standard of care and not the Buddy App. Dyad unit not reported, only the patient/subject. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only the patients (subjects) were enrolled in this part of the study, not dyads. The numbers only represent the patient subject enrollment numbers. Subjects were given phones loaded with the Buddy App, which was used to enter medications, issues, and orientation questions. They were seen on days 15 and 30 and received phone calls on days 7 and 21 inquiring about issues that would need medical attention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Buddy Subject Only/Not Dyad | Subjects will be given iphones loaded with the App that will be used to enter medications, issues and orientation questions. They will be seen at day 15 and day 30 and will receive a phone call day 7 and day 21 inquiring about issues that would need medical attention |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Avoidable Readmission | Avoidable Readmissions within 30 days. | Posted | Number | Number of Avoidable Readmissions | 30 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Buddy Subject Only/Not Dyad | Only the patients (subjects) were enrolled in this part of the study, not dyads. The numbers only represent the patient enrollment numbers. Patients were given phones loaded with the Buddy App, which was used to enter medications, issues, and orientation questions. They were seen on days 15 and 30 and received phone calls on days 7 and 21 inquiring about issues that would need medical attention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jasmohan Bajaj | Virginia Commonwealth University | (804) 828-4060 | jasmohan.bajaj@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2019 | May 20, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2020 | May 20, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard of Care Subject Only/Not Dyad |
Subjects randomized to standard of care and not the Buddy App |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| 0 |
| 116 |
| 0 |
| 116 |
| 0 |
| 116 |
| EG001 | Standard of Care Subject Only/Not Dyad | Subjects randomized to standard of care and not the Buddy App. Just the patients counted and reported, not the dyads. | 0 | 116 | 0 | 116 | 0 | 116 |
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