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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
The Simply B electronic GP support package consists of:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients living with hepatitis B | Experimental | Patients living with hepatitis B will be managed at the GP clinic using the Simply B e-support package |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Simply B Study | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36 months prior to study |
| 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 | 2 years |
| 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 | 2 years |
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36927591 | Derived | Moussa D, Wallace J, Manski-Nankervis JA, Doyle JS, Nguyen L, Boyle D, Stoove MA, Asselin J, Valaydon Z, Ahad M, Glasgow S, New K, Hocking JS, Sanci L, Thompson A, Hellard M, Howell J. Assessment 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 in Australia (SIMPLY-B Study): protocol for a pilot evaluation. BMJ Open. 2023 Mar 16;13(3):e070663. doi: 10.1136/bmjopen-2022-070663. |
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| 2 years |