Link Hepatitis C Notifications to Treatment in Tasmania

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Status: Enrolling

Conditions: Hepatitis C

Treatments: Behavioral: Enhanced case management

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04510246

Tas RCT HCV Notifications

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced case management

Control

No Intervention group

Description:

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.