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临床试验/NCT07191886
NCT07191886招募中不适用

Measuring Patient Reported Needs in Outpatient Liver Disease Management

Indiana University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Prevalence and Types of Health-Related Social Needs (HRSNs)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

结局指标

主要结局

Prevalence and Types of Health-Related Social Needs (HRSNs)

时间窗: Day 1

Proportion and categories of health-related social needs reported by patients with chronic liver disease using a structured HRSN survey.

次要结局

  • Provider Perspectives on HRSN Screening(Within 7 days of patient visit)
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Archita P. Desai

Assistant Professor of Medicine

Indiana University

研究点 (1)

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