Re-engaging Patients With Hepatitis C Into Care

Glasgow Royal Infirmary

Status: Unknown

Conditions: Hepatitis C, Chronic

Treatments: Behavioral: Incentive; Behavioral: Follow up phone call

Study type: Interventional

Funder types: Other

Identifiers

NCT04029246

GN19ID200

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 16 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 3 patient groups

Letter only

No Intervention group

Letter plus phone call

Active Comparator group

Treatment:

Behavioral: Follow up phone call

Letter plus incentive

Active Comparator group

Treatment:

Behavioral: Incentive