Clinical trial NCT04029246: Re-engaging Patients With Hepatitis C Into Care
Official title: Reengaging Patients With Previously Diagnosed Hepatitis C in to Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C, Chronic
Lead sponsor: Glasgow Royal Infirmary
Sponsor class: OTHER
Collaborators: name: Glasgow Caledonian University
First posted: 2019-07-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of attendance for liver assessment
timeFrame: 4 months
Secondary outcomes:
measure: Rates of initiation of Hepatitis C treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Stephen T Barclay, MBChB
role: PRINCIPAL_INVESTIGATOR
References: