Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum

Conditions

• Hepatitis C

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Patient-Centered Electronic App — OTHER
  The coordinator will enter lab information to generate the patient's Fibrosis-4 score for liver fibrosis staging. With the information of liver fibrosis staging and survey responses, the app will generate individualized reports of the participant's comprehensive HCV disease progression, knowledge, and level of interest in receiving HCV care. The app will then deliver a streamlined, tailored, brief education message and include information regarding services and assistance for receiving HCV care.

Study Details

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.

Key Dates

Start date

Mar 24, 2022

Status verified

Dec 2025

Primary completion

Jul 31, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

308 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Patient-Centered Electronic App Group
  Patients assigned to the intervention group will receive individualized reports regarding patients' HCV disease progress/liver fibrosis staging by a Fibrosis-4 score using the personalized HCV educational app. The individualized report will also include comprehensive knowledge to fill the gap on general HCV information, natural history of the disease, and care and treatment, if there is any, as well as level of interest in receiving HCV care based on patients' response to the short survey questionnaires on the tablet. Patients will also receive the investigators' HCV program pamphlet regarding HCV infection and disease progression, treatment, as well as information regarding clinics available for HCV care in Baltimore. Patients will receive standard of care, routine HCV LTC services from the investigators' ED HCV LTC program staff.
• No Intervention: Reference Group
  Patients assigned to the reference group will receive the investigators' current 'static' standard of care HCV program pamphlet regarding HCV infection and disease progression, treatment, as well as information regarding clinics available for HCV care in Baltimore City. Patients will also receive standard of care, routine HCV LTC services from the investigators' ED HCV LTC program staff.

Primary Outcome Measure

Linkage to care rate (days) [ Time Frame: 28 months ]

Central Contacts

• Deanna Myer
  443-287-6985
  [email protected]
• Tiana Jones
  410-735-6422
  [email protected]

Locations (1)

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