The SIMPLY-B Study

• Sponsor: Nadine Barnes (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05614466
• Collaborator: (none)
• Enrollment: 100
• Arm: 1
• Anticipated Duration (Months): 30

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Virus Related Hepatocellular Carcinoma	Other: The Simply B Study	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: SIMPLY-B Study - A Pilot Evaluation of a Primary Care E-support Package of Automated Case Finding, Simplified Treatment Algorithm and Decision Support to Increase Hepatitis B Treatment Uptake in Primary Care Clinics
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Oct 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

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

Other: The Simply B Study; 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 clinics 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 Part C: A mathematical modelling study using a Markov model to determine cost effectiveness of Simply B for increasing hepatitis B treatment uptake compared to status quo of hospital care.

Outcome Measures

Primary Outcome Measures

1. Number of patients previously diagnosed with chronic hepatitis B within each primary care clinic study site who have attended the clinic within the 36-month period prior to implementation of the intervention [36 months prior to study]

   Number of patients previously diagnosed with chronic hepatitis B within each primary care clinic study site who have attended the clinic within the 36-month period prior to implementation of the intervention

2. Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP [2 years]

   Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP

3. Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting [2 years]

   Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting

4. Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care [2 years]

   Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care

Secondary Outcome Measures

1. Acceptability and feasibility of using the Simply B package to facilitate hepatitis B management by GPs in primary care from health worker and patient perspectives. [2 years]

   Acceptability and feasibility of using the Simply B package to facilitate hepatitis B management by GPs in primary care from health worker and patient perspectives. This will be done via a 12-month post implementation semi-structured interview with GPs, nurses, practices managers and patients living with hepatitis B.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nadine Barnes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nadine Barnes, Manager, Research Grants and Research Integrity Office, Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• ClinicalTrials.gov Identifier: NCT05614466
• Other Study ID Numbers: SIMPLY-B Study
• First Posted: Nov 14, 2022
• Last Update Posted: Nov 14, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis B; Hepatitis

Study Results

No Results Posted as of Nov 14, 2022