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Hepatitis B Virus Related Hepatocellular CarcinomaNCT05614466

The SIMPLY-B Study

A study testing The Simply B Study in people with Hepatitis B Virus Related Hepatocellular Carcinoma, run by Nadine Barnes.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
The Simply B Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Apr 2023to Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 18 years of age
  • Already on hepatitis B treatment
  • Already attending hepatitis B specialist care
  • Hepatitis C or hepatitis D coinfection
  • HIV coinfection
  • Pregnant

About this 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

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

Read the 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.

Being tested
The Simply B Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Simply B StudyOther

    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.

Study groups in NCT05614466
Study groupRoleWhat they receive
Patients living with hepatitis BExperimentalPatients living with hepatitis B will be managed at the GP clinic using the Simply B e-support package
Receives: Other: The Simply B Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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

    Measured: 36 months prior to study

  2. 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

    Measured: 2 years

  3. 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

    Measured: 2 years

  4. 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

    Measured: 2 years

Secondary outcomes (1)

  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.

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study startApr 2023 (estimated)
  3. Primary completionJun 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05614466
Sponsor's protocol ID
SIMPLY-B Study
Status last verified
Nov 2022
First submitted
25 Oct 2022
Last updated
14 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36927591

Questions about this trial

What is this clinical trial studying?

A study testing The Simply B Study in people with Hepatitis B Virus Related Hepatocellular Carcinoma, run by Nadine Barnes.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05614466, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.

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