Re-engaging Patients With Hepatitis C Into Care

Study Overview
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Brief Summary
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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: Letter: Will be sent letter 1 (appendix) 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 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.

Official Title
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Reengaging Patients With Previously Diagnosed Hepatitis C in to Care

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Behavioral: Follow up phone call
* Behavioral: Incentive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Letter only<br> | |
| Active Comparator: Letter plus phone call<br> | Behavioral: Follow up phone call<br>* Telephone call to ask if patient has received letter and whether they would like an appointment<br>|
| Active Comparator: Letter plus incentive<br> | Behavioral: Incentive<br>* Offer of a shopping voucher if patient attends for appointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |