DEcentralize Testing, Education, and Linkage to Care by Using Electronic Best Practice Advisory for Hepatitis B (DETECT-B)

Viral Hepatitis B Clinical Trial

— DETECT-B  

Official title:

DEcentralize Testing, Education, and Linkage to Care by Using Electronic Best Practice Advisory for Hepatitis B (DETECT-B)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06403657
• Other study ID #: DETECT-B protocol
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Vietnam Viral Hepatitis Alliance
• Contact: Thanh Kim, MD
• Email: thanhkv[@]pnt.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of this implementation study is to determine if an enhanced model of hepatitis B testing and linkage to care could be integrated into a public healthcare facility. To answer this question, the investigators will

1. evaluate the effectiveness of the implementation program (overall impact or individual components) in increasing the use of testing services and linkage to hepatitis B care and treatment,

2. evaluate implementation fidelity, sustainability, and integration of the implementation study and

3. analyze the costs and cost-effectiveness of the implementation study.

Description:

Chronic hepatitis B (CHB) poses a significant public health challenge, particularly in low-income countries like Viet Nam. Despite the development of various diagnostic and treatment tools for hepatitis B, the delivery of these services remains suboptimal.

In response, the investigators seek to assess the feasibility of integrating an enhanced model for hepatitis B testing and linkage to care within a public healthcare facility. The study aims to address this issue through several key objectives:

1. Effectiveness Evaluation: The investigators will evaluate the impact of the implementation program on increasing the utilization of testing services and linkage to hepatitis B care and treatment. This includes assessing the overall impact as well as the effectiveness of individual program components.

2. Implementation Fidelity and Sustainability: The investigators aim to evaluate the fidelity of implementation, examine how well the program is executed, and assess its potential for sustainability and integration into routine healthcare practices.

3. Cost and Cost-Effectiveness Analysis: The investigators will analyze the costs associated with the implementation of the program and its cost-effectiveness in improving hepatitis B testing and linkage to care.

The implementation study is based at Le Van Thinh Hospital in Thu Duc City, Ho Chi Minh City. This study is guided by the EPIS (Explore - Prepare - Implement - Sustain) conceptual framework, which informs our research development, implementation, and evaluation strategies.

A mixed-method quasi-experimental type II hybrid effectiveness-implementation design will be employed. This involves implementing various strategies to enhance hepatitis B testing sequentially over a 12-month period. Strategies include medical education for primary care providers, electronic medical record-based reminders for testing, and point-of-care testing for CHB.

Effectiveness will be assessed using interrupted time series analysis with electronic medical record data. Sustainability will be gauged through interviews or focus group discussions with healthcare providers and patients. Cost evaluation will utilize activity-based costing and cost-effectiveness analysis.

The study aims to generate evidence on the effectiveness and implementation of an enhanced model for hepatitis B screening and care linkage within a primary care setting at a public hospital. The findings are anticipated to be applicable to similar settings in Viet Nam and other lower-middle-income countries globally.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria for patients

• Patients who visit the outpatient clinics at Le Van Thinh Hospital during the study period.

• Consent to use point-of-care HBsAg testing after being fully informed by the health care providers (this only applies during the last 4-month period where POC-HBsAg testing is introduced).

Exclusion criteria for patients: None

Inclusion criteria for healthcare providers and leaders

• Healthcare providers who work in the outpatient department and are involved in the enhanced model during the 12-month implementation period.

• Leaders who are involved in the enhanced model or make decisions or are authorized to to so relating to the enhanced model.

• Consent to join the in-depth interview or focus group after being fully informed by the study investigators.

Exclusion criteria for healthcare providers and leaders: None

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Viral Hepatitis B

Intervention

Other:
• An enhanced model of hepatitis B testing and linkage to care
Implementing CME sessions (<50 attendees) at Le Van Thinh Hospital will focus on preventive strategies for hepatitis B (HBV). We'll collaborate with IT to integrate a Best Practice Advisory (BPA) system into the hospital's electronic records for hepatitis B testing reminders. The system prompts healthcare workers when a patient lacks HBV screening notes, ensuring timely education and testing. Also, we'll introduce Point-of-Care (POC) HBsAg testing using SD Bioline HBsAg WB® for efficient screening and counseling, with follow-up to ensure care linkage within two weeks.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Vietnam Viral Hepatitis Alliance	Le Van Thinh Hospital, Viet Nam, University of Medicine and Pharmacy at Ho Chi Minh City

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number or proportion HBsAg testing at primary care clinics between pre- and implementation periods, extracted from electronic health records at Le Van Thinh hospital.	The primary care clinics include general internal medicine clinics and family medicine clinics, located in the outpatient department.	Up to 2 years (start one year before the implementation of the enhanced model and end one year after).
Primary	Sustainability of the implementation of the enhanced model, as assessed by EPIS-based semi-structured/structured questionnaires.	This is a qualitative outcome. The information will be collected through focus group discussions or in-depth interviews on healthcare staff. The EPIS (Exploration-Preparation-Implementation-Sustainment) is a conceptual framework used to guide the questionnaire and the discussions/interviews	At Month 12 of the implementation period
Primary	Activity-based costs	The scope of the costing was limited to program implementation costs.	At Month 12 of the implementation period
Secondary	Change in linkage to hepatitis B care between pre- and implementation periods, extracted from electronic health records at Le Van Thinh hospital.		Up to 2 years (start one year before the implementation of the enhanced model and end one year after).