DEcentralize Testing, Education, and Linkage to Care by Using Electronic Best Practice Advisory for Hepatitis B (DETECT-B)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- 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.
研究概览
简要总结
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
- 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,
- evaluate implementation fidelity, sustainability, and integration of the implementation study and
- analyze the costs and cost-effectiveness of the implementation study.
详细描述
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:
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Implementation of the enhanced model
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.
干预措施: An enhanced model of hepatitis B testing and linkage to care (Other)
结局指标
主要结局
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.
时间窗: Up to 2 years (start one year before the implementation of the enhanced model and end one year after).
The primary care clinics include general internal medicine clinics and family medicine clinics, located in the outpatient department.
Activity-based costs
时间窗: At Month 12 of the implementation period
The scope of the costing was limited to program implementation costs.
Sustainability of the implementation of the enhanced model, as assessed by EPIS-based semi-structured/structured questionnaires.
时间窗: At Month 12 of the implementation period
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
次要结局
- 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).)
研究者
Thanh Van Kim
Co-principal investigator
Pham Ngoc Thach University of Medicine