About the study

The HealthElink study is a prospective multicentre trial involving tertiary hospitals in South Australia, Northern Territory and Victoria in conjunction with referring General Practitioners. Recruitment has started in South Australia and Northern Territory.
 

Aims

To determine the feasibility, efficacy, cost, patient/clinician satisfaction and impact on community treatment initiation rate of the HealthElink eHealth system for treatment of chronic hepatitis C compared to community management via the remote-consultation form.

Primary Endpoints
  • Sustained virological response at 12-weeks post completion of anti-viral treatment for HCV with HealthELink (SVR12) on an intention-to-treat analysis compared to a retrospective cohort of community initiated direct-acting antiviral therapy for hepatitis C via remote consultation March 2016 – February 2017.
Secondary Endpoints
  • Time spent on HealthELink system (GP, patient and specialist).
  • Patient acceptability and satisfaction
  • General Practitioner acceptability, satisfaction and confidence in hepatitis C treatment prescription
  • Specialist team (nurse and specialist) acceptability and satisfaction
  • Treatment initiation number (stratified into metropolitan, rural, prison) per GP compared to period prior to HealthElink initiation.
  • Rates of loss to follow-up or completion of SVR12 testing
  • Waiting time between referral and treatment-initiation.
  • Proportion of General Practitioners achieving independence in hepatitis C prescribing using the system.
  • Uptake of the HealthElink system (measured by number of enrolled GPs using the system for referral).

 

Ethical Approval

This study will be conducted according to the NHMRC National Statement on Ethical Conduct in Human Research (2007). If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact:

The Royal Adelaide Hospital Research Ethics Committee Chairman on (08) 8222 4139. (South Australia)

The Menzies School of Health Research Ethics Committee Secretary on (08) 8946 8600 (Northern Territory)