Link Hepatitis C Notifications to Treatment in Tasmania

NCT ID: NCT04510246

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2022-03-30

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Practitioners randomised to the intervention arm will receive the standard of care surveillance letter if the notification is new. Both new and repeat notifications will receive further enhanced case support during the project if required. Support can be provided at the first phone call, or if accepted and required, in a 12-week period during which the DoH health care worker can do follow-up calls with the GP or directly with the patient to inform the patient and enhance linkage back to their GP. At the end of the 12-week period, a follow-up call we be carried out for the project evaluation.

Group Type: EXPERIMENTAL

Enhanced case management

Intervention Type: BEHAVIORAL

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.

Control

All practitioners randomised to this arm will be contacted by telephone approximately 12 weeks after an HCV notification has been made from the laboratory to the Department of Health.This is not current standard practise and will be performed by the DoH HCV health worker for the project evaluation purpose. At this phone call consent will be sought for the GP to provide information on their clinical management of the notified patient. The details of the clinical management survey are provided as Appendix B. Details provided or missing from the standard DoH surveillance form would be confirmed with the GP at this phone call. Three attempts will be made to contact the practitioner to complete the survey within a 30-day period before they are determined to be unable to be contacted.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Enhanced 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tasmanian Department of Health

Hobart, Tasmania, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Joseph Doyle, PhD

Role: CONTACT

joseph.doyle@burnet.edu.au

+613 9076 5436

Jacqui Richmond, PhD

Role: CONTACT

Jacqui.Richmond@burnet.edu.au

+614 8866 2268

Facility Contacts

Rachael L Barter

Role: primary

References

Marukutira T, Moore KP, Hellard M, Richmond J, Turner K, Pedrana AE, Melody S, Johnston FH, Owen L, Van Den Boom W, Scott N, Thompson A, Iser D, Spelman T, Veitch M, Stoove MA, Doyle J. Randomised controlled trial of active case management to link hepatitis C notifications to treatment in Tasmania, Australia: a study protocol. BMJ Open. 2022 Mar 25;12(3):e056120. doi: 10.1136/bmjopen-2021-056120.

Reference Type: DERIVED

PMID: 35338062 (View on PubMed)

Other Identifiers

Tas RCT HCV Notifications

Identifier Type: -

Identifier Source: org_study_id