Recruiting

Health-Related Social Needs

Sponsor:

Indiana University

Code:

NCT07191886

Conditions

Chronic Liver Disease

Cirrhosis, Liver

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07191886

Start date

Mar 5, 2024

Status verified date

Jul, 2026

Completion date

May 30, 2028

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient Inclusion criteria

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

Provider Inclusion Criteria • Participated in patient care during inclusion visit

Exclusion Criteria:

  • Patient Exclusion criteria

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

Provider Exclusion Criteria

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Prevalence and Types of Health-Related Social Needs (HRSNs) [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Archita Desai, MD

More Information

Sponsor

Indiana University

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-07-29.