A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
ConditionLiver Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
Patients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving quality of life, and improving patient experience.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female age ≥18
Diagnosis of advanced liver disease, defined as either (must meet either a or b)
biopsy
characteristic clinical, laboratory, and imaging findings
Disqualifiers
discharge under hospice
listed for liver transplant with MELD-Na ≥ 35
unable or unwilling to participate in post-discharge follow-up either in-person or virtually
unable to speak or understand English and/or Spanish
Trial design
Design model
Crossover
Treatments tested in this trial
Transitional Liver Clinic (TLC)
Other interventionParticipants in this intervention receive additional attention from their Hepatology providers in terms of an additional call/telemedicine visit and more specific/additional attention from their Hepatology APP (advanced practice provider) based on individual patient needs
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Transitional Liver Clinic (TLC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
30-day hospital readmissions for patients hospitalized with complications of advanced liver disease
The primary outcome, 30-day hospital readmission, is publicly reported by CMS, and is the benchmark measure in the Hospital Readmissions Reduction Program. It is therefore the most appropriate primary outcome.
Time frame
30 days after discharge of initial hospitalization at which the participant was enrolled in the study.2
Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
This measure includes 4 items in each of 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as a single item assessing pain intensity. Each domain is scored using a T-score metric in which 50 corresponds to the average for the US population with a standard deviation of 10, and a higher T-score represents more of the concept being measured. For example, higher fatigue scores indicate more fatigue (worse quality of life), while higher physical function scores represent better physical function (better quality of life).
Time frame
30 days after discharge of initial hospitalization at which the participant was enrolled in the study.3
Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
This measure includes 4 items in each of 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as a single item assessing pain intensity. Each domain is scored using a T-score metric in which 50 corresponds to the average for the US population with a standard deviation of 10, and a higher T-score represents more of the concept being measured. For example, higher fatigue scores indicate more fatigue (worse quality of life), while higher physical function scores represent better physical function (better quality of life).
Time frame
90 days after discharge of initial hospitalization at which the participant was enrolled in the study4
Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire
The PSQ-18 consists of 18 items examining 7 dimensions of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Each item is scored with a 1 to 5 Likert scale and the individual item scores are averaged, with higher scores reflecting higher satisfaction.
Time frame
30 days after discharge of initial hospitalization at which the participant was enrolled in the studySecondary outcomes
1
Number of ER visits
Recognizing the limitations on CMS data, the number of ER visits for each participant will be taken from the medical record and will be measured as a secondary outcome to provide a fuller picture of acute care utilization.
Time frame
30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the study2
90 day mortality
Recognizing the limitations on CMS data, 90 day mortality will be measured as a secondary outcome to provide a fuller picture of acute care utilization.
Time frame
90 days after discharge of initial hospitalization at which the participant was enrolled in the study.3
Days alive out of the hospital
Recognizing the limitations on CMS data, number of days alive out of the hospital will be measured as a secondary outcome to provide a fuller picture of acute care utilization.
Time frame
90 days after discharge of initial hospitalization at which the participant was enrolled in the study.4
Hospital readmissions
Participants will self report or data will be obtained from local institutional medical records the number of times, if any, they were admitted to the hospital during their time of participation in this study
Time frame
30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov