Measuring Patient Reported Needs in Outpatient Liver Disease Management

NCT ID: NCT07191886

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2027-05-30

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.

Detailed Description

Patients with chronic liver disease (CLD) are a medically and socially vulnerable population who often face significant health-related social needs (HRSNs), such as financial strain, housing instability, limited access to transportation, and lack of social support. These unmet needs contribute to poorer health outcomes and higher healthcare utilization, yet there is currently no validated screening tool specifically designed for patients with CLD. In addition, little is known about whether patients want their healthcare providers to address these needs, or how providers might use such information in routine practice.

This study is designed to measure the prevalence of HRSNs in patients with CLD receiving care in outpatient liver clinics, and to explore patient and provider perspectives on the role of HRSN screening in clinical care. Patients will complete surveys assessing HRSNs, health literacy, quality of life, social support, and patient activation, with additional demographic and clinical information obtained from chart review. Providers will complete surveys regarding their experience and potential use of HRSN data.

By combining patient- and provider-reported data, this study will generate new insights into the burden of unmet social needs in CLD, patient preferences for assistance from their care team, and provider attitudes toward incorporating HRSN data into clinical management. Findings are expected to inform the development and implementation of standardized HRSN screening approaches in liver disease care, with the broader goal of improving patient-centered outcomes and aligning with evolving healthcare quality standards.

Conditions

Chronic Liver Disease; Cirrhosis, Liver

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Unable to complete survey within 7 days of the inclusion visit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Archita P. Desai

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Savannah Yarnelle

Role: CONTACT

samussel@iu.edu

3172786424

Facility Contacts

Miranda Stovall

Role: primary

mirstova@iu.edu

(317) 278-2401

Other Identifiers

PRN Study

Identifier Type: -

Identifier Source: org_study_id