The SIMPLY-B Study

Nadine Barnes

Status: Not yet enrolling

Conditions: Hepatitis B Virus Related Hepatocellular Carcinoma

Treatments: Other: The Simply B Study

Study type: Interventional

Funder types: Other

Identifiers

NCT05614466

SIMPLY-B Study

Details and patient eligibility

About

This study will be conducted in three parts:

Part A: A prospective open label pilot intervention study, comparing the proportion of people with hepatitis B who are managed by their GP in primary care settings before, 12 months and 24 months after implementation of the Simply B electronic hepatitis B support package.

Part B: A nested qualitative health services feasibility study using semi -structured interviews and thematic analysis

Full description

The Simply B electronic GP support package consists of:

1. Semi-automated hepatitis B case-finding in the primary care clinic using clinic EMR software
2. Automated blood test ordering using clinic EMR software
3. A simplified hepatitis B treatment algorithm and online e-support tool that provides the GP with a simplified management plan based on clinical data entered into the tool by generating a hepatitis B chronic disease management plan.
4. Automated rapid linkage to specialist support through the e-support tool, with a follow up call from a specialist nurse provided within two business days of the initial patient/GP consultation.
5. Clinical data collection through the e-support tool into an online secure database, visible by the GP and hospital specialist, allowing automated reminders and monitoring of timely and appropriate hepatitis B management steps.
6. Linkage of de-identified data drawn from the Simply B database to the ACCESS and PATRON surveillance network to allow monitoring of progress toward National Strategy Hepatitis B treatment targets in primary care.

The e-support tool is based on an online RedCAP database accessible to both the GP and St Vincent's hospital specialist team via different interfaces and stored securely on the St Vincent's Hospital Cloud. The investigators have partnered with the Future Health Today (FHT) software development team (University of Melbourne) to integrate the Simply B e-support package into primary care electronic medical record software.

The GP enters demographic and pathology result data into a simple online data entry form. Based on a simplified hepatitis B management algorithm, this determines treatment eligibility and immediately generates an automatic patient management plan. For clinics that are part of the FHT network, FHT extracts demographic and pathology result data automatically and populates the Simply B tool, therefore the GP does not need to manually enter any data. Instructions of how to treat, monitor and perform liver cancer surveillance are included in the automated management plan.

The hospital specialist nurse and specialist clinicians have online access to the 'back end' of the Simply B e-support tool database, allowing them to monitor and enter data. This database contains all the demographic and clinical data entered by the GP in the e-support tool data entry form and automatically generates dates for follow up review, including date of next liver cancer surveillance if the patient fulfils eligibility criteria. Upcoming milestone appointments trigger alert emails to the GP and specialist hepatitis nurses facilitating timely hepatitis B management.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged ≥18 years
2. Attended participating primary care clinic in the preceding 36 months (June 1, 2019-June 30, 2022) or attended the clinic during the study period
3. HBsAg positive
4. Treatment naïve
5. Not receiving specialist hepatitis B care

Exclusion criteria

1. < 18 years of age
2. Already on hepatitis B treatment
3. Already attending hepatitis B specialist care
4. Hepatitis C or hepatitis D coinfection
5. HIV coinfection
6. Pregnant

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Patients living with hepatitis B

Experimental group

Description:

Patients living with hepatitis B will be managed at the GP clinic using the Simply B e-support package

Treatment:

Other: The Simply B Study