Clinical trial NCT03581383: Community Access, Retention in Care, and Engagement for Hepatitis C Treatment
Official title: Implementation of Two Novel Interdisciplinary Care Models and the Impact on Hepatitis C Treatment Uptake, Completion, Sustained Virologic Response, and Retention in Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Hepatitis C
Hep C
CARE-C
Kentucky
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2018-07-10
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 3 Arms: Two intervention models plus a control group representing standard practice Arm 4: And intervention model to record patient experiences with telemedicine
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main goals of the CARE-C study are to demonstrate the effectiveness of HCV models of care in a rural state (A) to overcome barriers to HCV treatment uptake, (B) to increase retention in care, and (C) to broaden access to care. To achieve these goals the following two systems interventions will be separately implemented: (1) Implementation of the Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) and related standard of care best practice PREP-C related interventions facilitated by a social worker-patient navigator team, and (2) implementation of a modified ECHO model (with one patient visit at specialty center to include PREP-C and fibrosis assessment in contrast to standard ECHO model). To test the effectiveness of our two systems interventions 600 patients will be equally distributed into three study arms representing 3 care models: Arm 1: Current Care Model (management with current interdisciplinary team); Arm 2: PREP-C Model (management with expanded interdisciplinary team (social worker, patient navigator, PREP-C); and Arm 3: Modified ECHO Model (management with expanded team in collaboration with community providers). An additional Arm 4 was started January 2021 to follow subjects experience with HCV management and treatment via telemedicine.

Detailed description: Hepatitis C virus (HCV) related complications (end-stage liver disease, liver cancer, and death) are increasing in the U.S., and extrapolated from U.S. data most of the estimated 49,200 patients with chronic hepatitis C in the state of Kentucky are untreated. In addition, the state of Kentucky is at the center of the rural opioid epidemic in the United States which has led to a dramatic increase in the transmission of hepatitis C virus (HCV) infection. HCV treatment uptake has been suboptimal in Kentucky despite the availability of highly effective, well-tolerated, timely limited treatment options due to multiple patient-, provider-, and system related barriers. Effective models of linkage to care, treatment, and retention in care are urgently needed to overcome the epidemiological challenges facing our rural state and put Kentucky on a path to planned elimination of HCV infection in the state. The demonstration of the effectiveness of new models of care in Kentucky which are appropriate to rural states will have great relevance and value to other states struggling with new HCV transmission and similar urgent need for effective models of linkage to care, treatment, and retention. Standardized care interventions expanding the reach of specialty providers (Project ECHO) and overcoming patient and provider related barriers to HCV treatment initiation (PREP-C assessment and interventions) have been evaluated, but the implementation of both models has been hampered by a lack of financial incentive, PREP-C has not been evaluated in rural populations, and the two models have never been used in conjunction.

The main goals of the study are to demonstrate the effectiveness of HCV models of care in a rural state (A) to overcome barriers to HCV treatment uptake, (B) to increase retention in care, and (C) to broaden access to care. To achieve these goals the following two systems interventions will be separately implemented: (1) Implementation of the Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) and related standard of care best practice PREP-C related interventions facilitated by a social worker-patient navigator team, and (2) implementation of a modified ECHO model (with one patient visit at specialty center to include PREP-C and fibrosis assessment in contrast to standard ECHO model). To test the effectiveness of our two systems interventions up to 1000 participants will be distributed into four study arms representing 4 care models: Arm 1, Current Care Model (management with current interdisciplinary team);arm 2, PREP-C Model (management with expanded interdisciplinary team (social worker, patient navigator, PREP-C); arm 3, Modified ECHO Model (management with expanded team in collaboration with community providers); and Arm 4, current Telemedicine care model (management with current interdisciplinary team).

The specific aims are:

Aim 1: To compare HCV treatment uptake within 12 months after the first clinic visit (time of enrollment) in all Arms 1, 2, and 3. It is hypothesized that (A) treatment uptake will be higher in Arms 2 (PREP-C model) and 3 (modified ECHO model) as compared to Arm 1 (current care model) as a result of overcoming patient level treatment barriers (such as ongoing substance use, psychiatric instability, non-compliance, loss to follow up) facilitated by implementation of the PREP-C assessment, PREP-C related interventions, and assistance of the social worker-patient navigator team, and (B) treatment uptake in Arm 3 will be non-inferior to Arm 2.

Aim 2: To compare HCV treatment outcomes (treatment completion and sustained virologic response, SVR12) in all arms 1, 2, and 3. It is hypothesized that treatment completion and SVR12 in arms 2 and 3 will be noninferior to arm 1 due PREP-C enhancement, even though expected additional patients who start treatment in Arms 2 and 3 are expected to have less favorable treatment readiness scores prior to PREP-C interventions due to higher rates of treatment uptake as hypothesized in Aim 1.

Aim 3: To compare retention in care in all 3 arms for patients who do not start treatment (within 12 months after initial appointment). It is hypothesized that retention in care will be higher in arms 2 and 3 due to implementation of PREP-C assessment and interventions, and the support through the patient navigator.

Aim 4: To record the treatment uptake and analyze patient experiences with telemedicine appointments in Arm 4, the telemedicine arm.

Eligibility criteria: Inclusion Criteria:

* First office visit for hepatitis C management
* Referred either (a) to the Hepatology Outpatient Clinic at the University of Kentucky in Lexington, Kentucky or (b) to a local community provider who can provide comprehensive care for HCV including HCV treatment in collaboration with the University of Kentucky as a spoke of the ECHO program
* Age 18 years and older

Exclusion Criteria:

* Life expectancy less than one year
* Less than 18 years old

Primary outcomes:
measure: HCV treatment initiation
timeFrame: 12 months
measure: HCV treatment completion
timeFrame: 12 months
measure: Sustained Virologic Response (SVR)
timeFrame: 12 weeks from treatment completion
Secondary outcomes:
measure: Missed clinic visits
timeFrame: 18 months
measure: Clinic visit consistency
timeFrame: 18 months
measure: Gaps in clinical care
timeFrame: 18 months
measure: Appointment adherence
timeFrame: 18 months
measure: Visit frequency within a twelve month period
timeFrame: 18 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jens Rosenau, MD
role: PRINCIPAL_INVESTIGATOR
References: