Chronic Liver DiseaseNCT07191886
Measuring Patient Reported Needs in Outpatient Liver Disease Management
An observational study of Chronic Liver Disease and Cirrhosis, Liver, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease, Cirrhosis, Liver
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 30 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Miranda Stovall, (317) 278-2401, mirstova@iu.edu
Archita Desai, MD
About this study
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.
Read the 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
- Keywords
- health-related social needs, social determinants of health, patient-reported outcomes, quality of life
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (4)
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Within 7 days of patient visit
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.
Measured: Day 1, with retrospective chart review (12 months prior healthcare utilization and labs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start5 Mar 2024
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Archita P. Desai, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191886
- Sponsor's protocol ID
- PRN Study
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Patient Reported Needs in Outpatient Liver Disease Management
- ClinicalTrials.gov ID
- NCT07191886
- Acronym / sponsor ID
- PRN Study
- Conditions
- Chronic Liver Disease, Cirrhosis, Liver
- Keywords
- health-related social needs, social determinants of health, patient-reported outcomes, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Patient Inclusion criteria
- Provider Inclusion Criteria • Participated in patient care during inclusion visit
Key exclusion criteria (6 listed)
- Patient Exclusion criteria
- Provider Exclusion Criteria
- Unable to complete survey within 7 days of the inclusion visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and Types of Health-Related Social Needs (HRSNs)
Time frame: Day 1
Proportion and categories of health-related social needs reported by patients with chronic liver disease using a structured HRSN survey.
4 secondary outcomes
Patient Preferences for Provider Involvement in Addressing HRSNs
Time frame: Day 1
Reasons Patients Decline Provider Assistance with HRSNs
Time frame: Day 1
Provider Perspectives on HRSN Screening
Time frame: Within 7 days of patient visit
Association Between HRSNs and Clinical Characteristics
Time frame: Day 1, with retrospective chart review (12 months prior healthcare utilization and labs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease and Cirrhosis, Liver, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Savannah Yarnelle (3172786424, samussel@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and Types of Health-Related Social Needs (HRSNs) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.