Clinical trial NCT04162938: Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum
Official title: Use of a Patient-Centered Electronic App to Increase Emergency Department Patient's Knowledge on HCV Infection, Disease Progression, and Care to Improve the HCV Care Continuum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis C
Keywords: HCV Linkage to Care
HCV Education
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will conduct a randomized controlled clinical trial study in an urban emergency department in Baltimore to determine the impact of an educational app which is based on Leventhal's Common-Sense Model of Illness Representations framework, on HCV-infected ED patient's hepatitis C virus (HCV) health belief and knowledge as well as the downstream outcomes of the HCV Continuum of Care (linkage to care rate, initiation of HCV antiviral treatment, and sustained virologic response). First, the investigators will develop a blueprinted prototype personalized HCV educational app which will (1) provide individualized liver fibrosis staging information, (2) pre-test HCV knowledge, perception of barriers to HCV care, and motivation to receive HCV care survey, (3) provide personalized HCV knowledge, facilitators and supporting information for HCV care via video clips and information sheets based on the pre-test results, and (4) provide post-test knowledge, perception, and motivation to receive HCV care. Second, the investigators will conduct a series of focus group discussion sessions to fine-tune the HCV educational app. Third, the investigators will enroll ED patients who have anti-HCV (newly diagnosed or previously diagnosed) but without HCV RNA testing information for a pilot randomized controlled clinical trial of the personalized HCV educational app.

Detailed description: An estimated 40-85% of 2.4 million Americans infected with HCV remain unaware of the infection. Further even amongst those aware of the HCV status, the vast majority do not get linked to care or are offered the option for treatment. Busy emergency department (ED) settings, which provide care to 140 million individuals each year, have recently been demonstrated to be a key venue for large-scale HCV testing, with outcomes from several large cities showing rates of disease of upwards of 10%. Significant challenges remain however, as linkage to care (LTC) from EDs has proven particularly elusive. National ED HCV LTC rates typically range from 20-40%, which dramatically restricts the overall impact on patient outcomes. Varied and complex factors contribute to these challenges but include both individual patient level factors, as well as social and health care infrastructure barriers. One critical but potentially mutable factor associated with gaps in LTC, that has yet to be systematically evaluated for ED populations, is the role of patient's comprehension of the 'meaning' of patients' HCV diagnosis, which includes understanding the natural history of the disease, and the associated downstream health consequences of being infected. Placing HCV in the context of a patient based conceptual disease model provides a framework for studying knowledge gaps and misperceptions, which could be used to help improve patient engagement in care, and ultimately both clinical and public health outcomes. Leventhal's Common-Sense Model of Illness Representations provides a foundational framework for understanding an individual's belief and coping strategy to respond to his or her illness, with reliance on both concrete and abstract information (e.g. symptoms or acquired knowledge). For HCV, variables that may impact patient's engagement include a relative lack of urgency to receive care (due to the indolent nature of symptoms and often decades-long disease progression), a perception of ineffective treatment options (rooting from interferon therapy), and the perception of a relative low morbidity and mortality risk associated with HCV (versus e.g. HIV). Leveraging this Common-Sense Model theoretical framework, the investigators' research team proposes to design and evaluate the impact of a patient-centered HCV health belief conception framework for improving LTC interventions and the downstream HCV care continuum. Individualized risk information will be delivered in a patient-centric manner in the ED, gathering easily obtainable data that has proven to predict progression (i.e. Fibrosis-4 score). The investigators propose to first conduct a series of 3 focus group discussion sessions for participants to provide constructive comments and suggestions on the prototype of the personalized HCV educational app which has been blueprinted and is currently under development. This will be followed by development and pilot testing of a personalized patient-centered tablet-facilitated HCV educational program app, focusing on improving patient knowledge regarding HCV in real-time (including using and ED-based fibrosis staging service from precision medicine perspective). The patient informed staging service will include an estimated non-invasive Fibrosis-4 score; a serum fibrosis marker index (includes age, platelet count, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) values). The investigators hypothesize that providing individualized HCV disease progression staging information to ED patients, along with a structured educational LTC program to HCV-infected patients during patients' ED visit, will significantly change patient's health beliefs and perceptions of HCV, and motivate patients to achieve improved rates of LTC, retention in care, anti-viral treatment, and sustained virologic response along the HCV care cascade.

Eligibility criteria: Inclusion Criteria:

* Johns Hopkins Hospital ED patient
* 18 years or older
* HCV positive without HCV RNA information

Exclusion Criteria:

* Younger than 18 years of age
* Unable to provide informed consent
* Altered mental status
* Incarcerated
* Critically ill

Primary outcomes:
measure: Linkage to care rate (days)
timeFrame: 28 months
Secondary outcomes:
measure: Change in HCV knowledge as assessed by True/False survey questions
timeFrame: Immediately before and immediately after use of the education app, up to 1 hour
measure: Change in perceived barriers to HCV care as assessed by a Likert Scale
timeFrame: Immediately before and immediately after use of the education app, up to 1 hour
measure: Change in level of motivation to receive HCV care as assessed by a Likert Scale
timeFrame: Immediately before and immediately after use of the education app, up to 1 hour
measure: Number of patients who begin HCV antiviral treatment
timeFrame: 28 months
measure: Number of patients who complete HCV antiviral treatment
timeFrame: 28 months
measure: Number of patients who have an undetectable viral load 12 weeks after completing HCV antiviral treatment
timeFrame: 28 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Yu-Hsiang Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
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