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

NCT06403657 | Not Yet Recruiting DMC

• 1 other identifier: DETECT-B protocol
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.evaluate implementation fidelity, sustainability, and integration of the implementation study and
3. 3.analyze the costs and cost-effectiveness of the implementation study.

Conditions

Viral Hepatitis B

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• 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).

Study Arms (1)

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.

Other: An enhanced model of hepatitis B testing and linkage to care

Interventions

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.

Implementation of the enhanced model

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vietnam Viral Hepatitis Alliance: lead
• Le Van Thinh Hospital: collaborator
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Thanh Kim, MD

  Pham Ngoc Thach University of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanh Kim, MD

CONTACT

thanhkv@pnt.edu.vn

Trang Nguyen, MSc

CONTACT

84903013493; trangnht33@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share