Re-engaging Patients With Hepatitis C Into Care

Hepatitis C, Chronic Clinical Trial

Official title:

Reengaging Patients With Previously Diagnosed Hepatitis C in to Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04029246
• Other study ID #: GN19ID200
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: July 2020
• Source: Glasgow Royal Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aims:

To evaluate the impact of a letter, phone call and incentive in re-engaging patients with hepatitis C care.

Outcomes of interest:

Primary outcome of interest:

• Attendance for assessment of liver disease within 4 months of being sent invitation letter.

Secondary outcomes of interest:

• Commencing treatment within 6 months of being sent invitation letter.

Methods:

Patient identification:

The local copy of the Scottish Hepatitis C database holds data regarding patients referred to secondary care for treatment of their hepatitis C, and holds ethics approval for research on treatment and patient outcomes. This will be used to identify patients with hepatitis C infection that is untreated, treatment has been unsuccessful, or the patient has been treated but the outcome is unknown (due to non attendance for blood tests). The database has been cross checked with virus lab results, to ensure infection status is up to date. Finally, the patient data has been checked by NHS GG&C information team, to exclude patients who are deceased, or whom are no longer resident in NHS greater Glasgow and Clyde based on updated details obtained from SCIstore.

Inclusion criteria:

Patients (16 years and over) who have previously engaged with Hepatitis C services in Glasgow but who are either untreated, have been treated unsuccessfully, or have been treated but have not attended for blood tests to check for treatment success.

Exclusion criteria:

Patients with HIV. Patients no longer resident within NHS Greater Glasgow and Clyde area.

Allocation to contact groups:

Patients will be randomly distributed into 3 groups:

1. Letter: Will be sent letter 1 (appendix)

2. Letter plus telephone call: will be sent letter 2 (appendix) and be followed up with a telephone call from the treatment centre if no contact has been received after 4 weeks

3. Letter plus incentive: will be sent letter 3 (appendix)

Process:

Patient letters will be sent out by GG&C public health. For all 3 groups the letter will be sent with the small Hepatitis C Scotland booklet "Hepatitis C treatments have changed".

Letters will identify include the telephone number for the identified treatment centre which will be either, the last known treatment centre or a more local treatment centre were appropriate based on current residence.

Primary and secondary outcomes measures will be collected via the Scottish Hepatitis C database.

Lay Summary:

This study will test whether a letter alone, a letter plus follow up phone call or a letter with offer of incentive, will be most effective in re-engaging patients who are known to have hepatitis C but not yet received treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 110 Years

Eligibility

Inclusion Criteria:

• Age 16 years or older

• Known hepatitis C infection which is either:

• untreated

• treated but the outcome of treatment unknown

Exclusion Criteria:

• Known HIV infection

• No longer resident within NHS Greater Glasgow and Clyde area

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Behavioral:
• Follow up phone call
Telephone call to ask if patient has received letter and whether they would like an appointment
• Incentive
Offer of a shopping voucher if patient attends for appointment

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Glasgow Royal Infirmary	Glasgow Caledonian University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of attendance for liver assessment	Rates of attendance for assessment of liver disease within a 4 month period, recorded as a binary (yes/no) outcome	4 months
Secondary	Rates of initiation of Hepatitis C treatment	Rates of initiation of treatment for hepatitis C within a 6 month period, recorded as a binary (yes/no) outcome.	6 months