Link Hepatitis C Notifications to Treatment in Tasmania
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04510246|
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Behavioral: Enhanced case management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study will be a two-armed cluster randomised controlled trial with randomisation at the level of the general practitioner.|
|Masking:||Double (Participant, 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.|
|Official Title:||A Randomised Controlled Trial of Active Case Management to Link Hepatitis C Notifications to Hepatitis C Treatment in Tasmania|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||March 2022|
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
The health care worker will offer support to the GP for all aspects of the cascade of hepatitis C care including:
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.
No Intervention: 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.
- Proportion of cases notified with hepatitis C who commence hepatitis C treatment [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510246
|Contact: Joseph Doyle, PhD||+613 9076 firstname.lastname@example.org|
|Contact: Jacqui Richmond, PhD||+614 8866 2268||Jacqui.Richmond@burnet.edu.au|