Link Hepatitis C Notifications to Treatment in Tasmania

NCT04510246 | Unknown

• 1 other identifier: Tas RCT HCV Notifications
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of cases notified with hepatitis C who commence hepatitis C treatment

  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.

  The study follow up period is 12 weeks

Secondary Outcomes (3)

• Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result

  The study follow up period is 12 weeks

• Proportion of people diagnosed with hepatitis C completing treatment work-up blood tests

  The study follow up period is 12 weeks

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Enhanced case management

Control

NO INTERVENTION

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.

Interventions

Enhanced case management 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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health

You may not qualify if:

• Not based in Tasmania
• Practitioner from correctional service
• Specialist
• Nurse practitioner who initiated test
• Sexual health service doctor
• Family planning
• Trainee

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Tasmanian Department of Health

Hobart, Tasmania, 7001, Australia

RECRUITING

Related Publications (1)

• 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.

  PMID: 35338062 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Joseph Doyle, PhD

CONTACT

+613 9076 5436; joseph.doyle@burnet.edu.au

Jacqui Richmond, PhD

CONTACT

+614 8866 2268; Jacqui.Richmond@burnet.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a two-armed cluster randomised controlled trial with randomisation at the level of the general practitioner.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: September 8, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 30, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 6 months of study completion
• Access Criteria: Full data file will be available to be shared after study completion.

Locations

AU (1)