The SIMPLY-B Study
Primary Purpose
Hepatitis B Virus Related Hepatocellular Carcinoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Simply B Study
Sponsored by
About this trial
This is an interventional other trial for Hepatitis B Virus Related Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria: Aged ≥18 years Attended participating primary care clinic in the preceding 36 months (June 1, 2019-June 30, 2022) or attended the clinic during the study period HBsAg positive Treatment naïve Not receiving specialist hepatitis B care Exclusion Criteria: < 18 years of age Already on hepatitis B treatment Already attending hepatitis B specialist care Hepatitis C or hepatitis D coinfection HIV coinfection Pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients living with hepatitis B
Arm Description
Patients living with hepatitis B will be managed at the GP clinic using the Simply B e-support package
Outcomes
Primary Outcome Measures
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
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
Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP
Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP
Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting
Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting
Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care
Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05614466
Brief Title
The SIMPLY-B Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nadine Barnes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
Detailed Description
The Simply B electronic GP support package consists of:
Semi-automated hepatitis B case-finding in the primary care clinic using clinic EMR software
Automated blood test ordering using clinic EMR software
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.
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Virus Related Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients living with hepatitis B
Arm Type
Experimental
Arm Description
Patients living with hepatitis B will be managed at the GP clinic using the Simply B e-support package
Intervention Type
Other
Intervention Name(s)
The Simply B Study
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
36 months prior to study
Title
Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP
Description
Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP
Time Frame
2 years
Title
Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting
Description
Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting
Time Frame
2 years
Title
Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care
Description
Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged ≥18 years
Attended participating primary care clinic in the preceding 36 months (June 1, 2019-June 30, 2022) or attended the clinic during the study period
HBsAg positive
Treatment naïve
Not receiving specialist hepatitis B care
Exclusion Criteria:
< 18 years of age
Already on hepatitis B treatment
Already attending hepatitis B specialist care
Hepatitis C or hepatitis D coinfection
HIV coinfection
Pregnant
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The SIMPLY-B Study
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