Hepatitis C
Conditions
Brief summary
This project will utilise the notification process as a point of intervention to work with primary practitioners (GP) by contacting them directly when a notification of hepatitis C exposure is received by the Tasmanian department of Health (DoH). A designated role will exist within DoH of a specialist HCV health worker to contact GPs to provide supported assistance in the process of the follow up hepatitis C diagnoses with patients. The study will evaluate whether active follow up of providers with enhanced case management is effective in having patients linked to hepatitis C treatment compared to current standard of care of surveillance for new notifications. The study will also compare the cost-effectiveness of this approach compared to current standard of care after one of their patients is notified with a positive hepatitis C antibody result.
Interventions
BEHAVIORALEnhanced case management
The health care worker will offer support to the GP for all aspects of the cascade of hepatitis C care including: * Further testing advice * Awareness that treatment can be prescribed by the general practitioner * Conducting pre-treatment work-up assessment * DAA prescription guidelines, including linkage to specialist consultation * Providing treatment support * Advising on testing process for cure * Advising on post-cure management including methods of follow-up to manage risks (e.g. harm minimisation, reducing re-infection risk, opioid substitution therapy) * Linking GP to resources for patients with cirrhosis or other concerns to specialist support for ongoing management. The GP will be offered the option of the DoH specialist to contact the patient directly with the GP's consent to notify them of their result and to educate them on testing and treatment options and referral back to their GP.
Sponsors
Department of Health and Human Services
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Given the nature of the intervention, it is impossible to blind either the health care worker or the general practitioner to allocation. However, the analysis will be conducted by an analyst at the Burnet Institute who will not have contact with the general practitioners and will be blinded to intervention allocation.
Intervention model description
This study will be a two-armed cluster randomised controlled trial with randomisation at the level of the general practitioner.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health
Exclusion criteria
* Not based in Tasmania * Practitioner from correctional service * Specialist * Nurse practitioner who initiated test * Sexual health service doctor * Family planning * Trainee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of cases notified with hepatitis C who commence hepatitis C treatment | The study follow up period is 12 weeks | The primary outcome will be the proportion of cases notified with hepatitis C who commence hepatitis C treatment within 12 weeks of initial contact. This will be assessed using the information provided by practitioners at the 12-week follow-up phone call and will be compared across the two arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result | The study follow up period is 12 weeks | The the proportion of cases notified with hepatitis C with documented HCV RNA results within 12 weeks of initial contact. This will be assessed using lab data and information provided by practitioners. |
| Proportion of people diagnosed with hepatitis C completing treatment work-up blood tests | The study follow up period is 12 weeks | The the proportion of HCV RNA positive cases who completed treatment work up blood tests within 12 weeks of initial contact. This will be assessed using lab data and information provided by practitioners. |
| Proportion of people diagnosed with hepatitis C completing an appropriate course of hepatitis C treatment as prescribed | The study follow up period is 12 weeks | The the proportion of HCV cases who complete an appropriate course of prescribed hepatitis C treatment.. |
Countries
Australia
Contacts
Primary ContactJoseph Doyle, PhD
Backup ContactJacqui Richmond, PhD
Outcome results
None listed