Measuring Patient Reported Needs in Outpatient Liver Disease Management

NCT07191886 | Recruiting

• 1 other identifier: PRN Study
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Liver Disease; Cirrhosis, Liver

Keywords

health-related social needs; social determinants of health; patient-reported outcomes; quality of life

Outcome Measures

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.

  Day 1

Secondary Outcomes (4)

• Patient Preferences for Provider Involvement in Addressing HRSNs

  Day 1

• Reasons Patients Decline Provider Assistance with HRSNs

  Day 1

• Provider Perspectives on HRSN Screening

  Within 7 days of patient visit

• Association Between HRSNs and Clinical Characteristics

  Day 1, with retrospective chart review (12 months prior healthcare utilization and labs)

Study Arms (2)

Patients with Chronic Liver Disease

Adults (≥18 years) with chronic liver disease receiving outpatient care in hepatology clinics at Indiana University Health University Hospital. Participants will complete surveys assessing health-related social needs, health literacy, quality of life, social support, patient activation, and technology use. Relevant demographic, medical history, and clinical data will also be abstracted from the electronic medical record.

Outpatient Liver Care Providers

Healthcare providers (physicians, nurse practitioners, physician assistants, or other clinical staff) who deliver care to enrolled patients during study visits. Providers will complete a survey regarding their experiences with health-related social needs screening and perspectives on how this information might be integrated into routine practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Age 18 or greater
• English speaking
• Ability to give consent (West Haven stage 0-1 if history of hepatic encephalopathy)

You may not qualify if:

• History of liver transplant
• Individuals not willing to participate in the survey
• Patients with severe cognitive impairment

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Savannah Yarnelle

CONTACT

3172786424; samussel@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: March 5, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)