Measuring Patient Reported Needs in Outpatient Liver Disease Management
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIndiana University
About this trial
This prospective study aims to assess health-related social needs (HRSNs) among patients with chronic liver disease (CLD) receiving outpatient care at Indiana University Health. Patients with CLD often face socioeconomic challenges that adversely affect health outcomes, but no validated screening tool exists for this population. The primary objective is to measure the prevalence and types of HRSNs in CLD patients. Secondary objectives are to evaluate patient preferences regarding provider involvement in addressing social needs, explore reasons for declining assistance, and assess provider perspectives on incorporating HRSN data into clinical care.
A total of 200 adult patients with CLD and their visit providers will be enrolled. Participants will complete surveys on demographics, HRSNs, health literacy, quality of life, social support, and patient activation, with medical data supplemented from chart review. Providers will complete surveys about their experiences using HRSN data in routine practice. Results will describe unmet social needs in this population, patient and provider attitudes toward screening, and inform strategies for integrating HRSN assessments into liver disease management and routine healthcare delivery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient Inclusion criteria
Age 18 or greater
English speaking
Ability to give consent (West Haven stage 0-1 if history of hepatic encephalopathy)
Disqualifiers
Patient Exclusion criteria
History of liver transplant
Individuals not willing to participate in the survey
Patients with severe cognitive impairment
Trial population
Adults with chronic liver disease receiving outpatient care in hepatology clinics at Indiana University Health University Hospital and providers delivering care during the study visits.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: Patients with Chronic Liver Disease
Group B: Outpatient Liver Care Providers
Trial outcomes
Primary outcomes
1
Prevalence and Types of Health-Related Social Needs (HRSNs)
Proportion and categories of health-related social needs reported by patients with chronic liver disease using a structured HRSN survey.
Time frame
Day 1Secondary outcomes
1
Patient Preferences for Provider Involvement in Addressing HRSNs
Proportion of patients who indicate they would like their liver care team to assist with addressing identified social needs, as measured by survey responses.
Time frame
Day 12
Reasons Patients Decline Provider Assistance with HRSNs
Reported reasons why patients prefer not to seek provider assistance with social needs, captured through structured survey items.
Time frame
Day 13
Provider Perspectives on HRSN Screening
Provider-reported attitudes and experiences with HRSN screening, including perceived usefulness and likelihood of incorporating results into clinical care, as measured by provider survey.
Time frame
Within 7 days of patient visit4
Association Between HRSNs and Clinical Characteristics
Relationship between reported HRSNs and clinical factors such as comorbidities, liver disease etiology, hospitalizations, ED visits, and MELD-Na score, using statistical correlation analyses.
Time frame
Day 1, with retrospective chart review (12 months prior healthcare utilization and labs)Sponsors and contacts
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Source ClinicalTrials.gov