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| Name | Class |
|---|---|
| Le Van Thinh Hospital | OTHER_GOV |
| University of Medicine and Pharmacy at Ho Chi Minh City | OTHER |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation of the enhanced model | Experimental | The enhanced model of hepatitis testing and linkage to care includes three implementation interventions: 1) continued medical education (CME) for primary health providers, 2) electronic health records-based best practice alerts (BPA) for chronic hepatitis B testing, 3) point-of-care HBsAg testing (POC). These implementation interventions will be introduced sequentially and cumulatively every four months for 12 months. For example, during the first 4-month period, only CME is implemented. In the next 4 months, BPA will be introduced, coupled with the ongoing CME. In the last 4 months, POC will be introduced, together with the ongoing CME and BPA. Since this implementation study is single-sited, the period before the implementation will be used as a control arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An enhanced model of hepatitis B testing and linkage to care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| 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 |
| Activity-based costs | The scope of the costing was limited to program implementation costs. | At Month 12 of the implementation period |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion criteria for patients
Exclusion criteria for patients: None
Inclusion criteria for healthcare providers and leaders
Exclusion criteria for healthcare providers and leaders: None
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thanh Kim, MD | Contact | thanhkv@pnt.edu.vn | ||
| Trang Nguyen, MSc | Contact | 84903013493 | trangnht33@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Thanh Kim, MD | Pham Ngoc Thach University of Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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There are two periods - pre-implementation (used as control) and implementation. The enhanced model will be rolled out in the implementation phase. The change in hepatitis B testing will be evaluated for effectiveness.
The enhanced model of hepatitis testing and linkage to care includes three implementation interventions: 1) continued medical education (CME) for primary health providers, 2) electronic health records-based best practice alerts (BPA) for chronic hepatitis B testing, 3) point-of-care HBsAg testing (POC). These implementation interventions will be introduced sequentially and cumulatively every four months for 12 months. For example, during the first 4-month period, only CME is implemented. In the next 4 months, BPA will be introduced, coupled with the ongoing CME. In the last 4 months, POC will be introduced, together with the ongoing CME and BPA.
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |