Trial Outcomes & Findings for Health IT Generated PROs to Improve Outcomes in Cirrhosis (NCT NCT03564626)
NCT ID: NCT03564626
Last Updated: 2025-09-17
Results Overview
Avoidable readmissions within 30 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
232 participants
Primary outcome timeframe
30 days
Results posted on
2025-09-17
Participant Flow
Participant milestones
| Measure |
Control Group/Not Dyad
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.
|
Health IT +/- Scheduled Follow Up/ no Dyads
No dyads enrolled. 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
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
116
|
|
Overall Study
COMPLETED
|
116
|
116
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Health IT Generated PROs to Improve Outcomes in Cirrhosis
Baseline characteristics by cohort
| Measure |
Control Group/ no Dyads
n=116 Participants
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.
|
Health IT +/- Scheduled Follow Up/ no Dyads
n=116 Participants
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
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.42 years
STANDARD_DEVIATION 8.89 • n=99 Participants
|
59.1 years
STANDARD_DEVIATION 12.38 • n=107 Participants
|
58.8 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
220 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=99 Participants
|
116 participants
n=107 Participants
|
232 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 daysAvoidable readmissions within 30 days
Outcome measures
| Measure |
Control Group/ No Dyads
n=116 Participants
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. Just the patients counted and reported, not the dyads.
|
Health IT +/- Scheduled Follow Up/ no Dyads
n=116 Participants
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
|
|---|---|---|
|
Avoidable Readmissions
|
12 Number of avoidable readmissions
|
23 Number of avoidable readmissions
|
Adverse Events
Control Group/ no Dyads
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health IT +/- Scheduled Follow Up/ no Dyads
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place