Re-engaging Patients With Hepatitis C Into Care

NCT04029246 | Unknown

• 1 other identifier: GN19ID200
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 1.Letter: Will be sent letter 1 (appendix)
2. 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. 3.Letter plus incentive: will be sent letter 3 (appendix)

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rates of initiation of Hepatitis C treatment

  6 months

Study Arms (3)

Letter only

NO INTERVENTION

Letter plus phone call

ACTIVE COMPARATOR

Behavioral: Follow up phone call

Letter plus incentive

ACTIVE COMPARATOR

Behavioral: Incentive

Interventions

Follow up phone call BEHAVIORAL

Telephone call to ask if patient has received letter and whether they would like an appointment

Letter plus phone call

Incentive BEHAVIORAL

Offer of a shopping voucher if patient attends for appointment

Letter plus incentive

Eligibility Criteria

• Age: 16 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16 years or older
• Known hepatitis C infection which is either:
• untreated
• treated but the outcome of treatment unknown

You may not qualify if:

• Known HIV infection
• No longer resident within NHS Greater Glasgow and Clyde area

Sponsors & Collaborators

• Glasgow Royal Infirmary: lead
• Glasgow Caledonian University: collaborator

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen T Barclay, MBChB

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Hepatologist

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 23, 2019
• Study Start: November 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)