Understanding social and health needs of people with chronic liver disease in outpatient care
Measuring Patient Reported Needs in Outpatient Liver Disease Management
This project will see how common social needs are and whether adults with chronic liver disease want their outpatient providers to help with them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07191886 on ClinicalTrials.gov |
What this trial studies
This prospective observational project will enroll 200 adult patients with chronic liver disease seen in outpatient liver clinics at Indiana University Health and their visit providers. Patients will complete surveys on demographics, health-related social needs (HRSNs), health literacy, quality of life, social support, and patient activation, with clinical details obtained from chart review. Visit providers will complete surveys about their experiences using HRSN information and their preferences for incorporating it into care. The combined patient- and provider-reported data will describe the prevalence and types of HRSNs, patient preferences for assistance, and provider perspectives on integrating HRSN screening into routine liver care.
Who should consider this trial
Good fit: Adults (age 18+) with chronic liver disease receiving outpatient care at Indiana University Health who are English-speaking, able to give consent (West Haven stage 0–1 if history of hepatic encephalopathy), and who have not had a liver transplant.
Not a fit: People who have had a liver transplant, are not English-speaking, have severe cognitive impairment, or are unwilling or unable to complete the surveys are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this work could help clinics identify and address patients' social needs, potentially improving care coordination, health outcomes, and quality of life for people with chronic liver disease.
How similar studies have performed: HRSN screening tools have been implemented and shown usefulness in other chronic disease populations, but few validated tools exist specifically for chronic liver disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Indianapolis, Indiana
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Savannah Yarnelle
- Email: samussel@iu.edu
- Phone: 3172786424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.