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

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04162938
Collaborator
(none)
308
Enrollment
1
Location
2
Arms
34.3
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient-Centered Electronic App
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
308 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Mar 24, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Patient-Centered Electronic App
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.
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.

Outcome Measures

Primary Outcome Measures

  1. Linkage to care rate (days) [28 months]

    Linkage to care rate is defined as the time (days) between patient enrollment and the patient's first HCV-related clinic visit.

Secondary Outcome Measures

  1. Change in HCV knowledge as assessed by True/False survey questions [Immediately before and immediately after use of the education app, up to 1 hour]

    The survey uses True/False responses to twenty questions with scores ranging from 0 to 20. An increase in the patient's total number of correct answers indicates an increase in the patient's HCV knowledge.

  2. Change in perceived barriers to HCV care as assessed by a Likert Scale [Immediately before and immediately after use of the education app, up to 1 hour]

    The survey uses a Likert Scale with 27 items; each item scored from 1 to 4. Overall score ranges between 27 and 108; a decrease in the patient's total score indicates a decrease in the patient's perceived barriers to HCV care.

  3. Change in level of motivation to receive HCV care as assessed by a Likert Scale [Immediately before and immediately after use of the education app, up to 1 hour]

    The survey uses a Likert Scale with 27 items; each item scored from 1 to 4. Overall score ranges between 27 and 108; a decrease in the patient's total score indicates an increase in the patient's motivation to receive HCV care.

  4. Number of patients who begin HCV antiviral treatment [28 months]

    Number of patients who begin HCV antiviral treatment will be used to measure initiation of HCV antiviral treatment rate.

  5. Number of patients who complete HCV antiviral treatment [28 months]

    Number of patients who complete HCV antiviral treatment will be used to measure the completion of HCV antiviral treatment rate.

  6. Number of patients who have an undetectable viral load 12 weeks after completing HCV antiviral treatment [28 months]

    Number of patients who have an undetectable viral load 12 weeks after completing HCV antiviral treatment will be used to measure the sustained virologic response rate.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins University Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

  • Principal Investigator: Yu-Hsiang Hsieh, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04162938
Other Study ID Numbers:
  • IRB00227304
First Posted:
Nov 14, 2019
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
HCV Linkage to Care
HCV Education
Additional relevant MeSH terms:
Hepatitis C

Study Results

No Results Posted as of Apr 7, 2022