Re-engaging Patients With Hepatitis C Into Care
Primary Purpose
Hepatitis C, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Follow up phone call
Incentive
Sponsored by
About this trial
This is an interventional health services research trial for Hepatitis C, Chronic
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
Sites / Locations
- Glasgow Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Letter only
Letter plus phone call
Letter plus incentive
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04029246
First Posted
July 15, 2019
Last Updated
July 21, 2020
Sponsor
Glasgow Royal Infirmary
Collaborators
Glasgow Caledonian University
1. Study Identification
Unique Protocol Identification Number
NCT04029246
Brief Title
Re-engaging Patients With Hepatitis C Into Care
Official Title
Reengaging Patients With Previously Diagnosed Hepatitis C in to Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glasgow Royal Infirmary
Collaborators
Glasgow Caledonian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Letter only
Arm Type
No Intervention
Arm Title
Letter plus phone call
Arm Type
Active Comparator
Arm Title
Letter plus incentive
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Follow up phone call
Intervention Description
Telephone call to ask if patient has received letter and whether they would like an appointment
Intervention Type
Behavioral
Intervention Name(s)
Incentive
Intervention Description
Offer of a shopping voucher if patient attends for appointment
Primary Outcome Measure Information:
Title
Rate of attendance for liver assessment
Description
Rates of attendance for assessment of liver disease within a 4 month period, recorded as a binary (yes/no) outcome
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Rates of initiation of Hepatitis C treatment
Description
Rates of initiation of treatment for hepatitis C within a 6 month period, recorded as a binary (yes/no) outcome.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen T Barclay, MBChB
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glasgow Royal Infirmary
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Re-engaging Patients With Hepatitis C Into Care
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