Implementation of Two Novel Interdisciplinary Care Models and the Impact on Hepatitis C Treatment Uptake, Completion, Sustained Virologic Response, and Retention in Care

Community Access, Retention in Care, and Engagement for Hepatitis C Treatment

Sponsors

Lead sponsor: Jens Rosenau

Source University of Kentucky
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).

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 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).

The specific aims are:

Aim 1: To compare HCV treatment uptake within 12 months after the first clinic visit (time of enrollment) in all 3 arms. 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 3 arms. 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.

Overall Status Active, not recruiting
Start Date August 21, 2018
Completion Date April 2021
Primary Completion Date April 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
HCV treatment initiation 12 months
HCV treatment completion 12 months
Sustained Virologic Response (SVR) 12 weeks from treatment completion
Secondary Outcome
Measure Time Frame
Missed clinic visits 18 months
Clinic visit consistency 18 months
Gaps in clinical care 18 months
Appointment adherence 18 months
Visit frequency within a twelve month period 18 months
Enrollment 600
Condition
Intervention

Intervention type: Behavioral

Intervention name: PREP-C

Description: The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) is an interactive online tool that enables providers to provide a thorough assessment of a patient's psychosocial readiness to begin Hepatitis C treatment, and make a treatment plan to improve treatment readiness.

Intervention type: Behavioral

Intervention name: Modified ECHO

Description: The heart of the ECHO (Extension for Community Health Outcomes) model is its hub-and-spoke knowledge-sharing networks, led by expert teams who use multi-point videoconferencing to conduct virtual clinics with community providers. The key modification is one patient visit in the specialty center resulting in co-management of patients with data sharing.

Arm group label: Modified ECHO Model

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

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jens Rosenau, MD Principal Investigator University of Kentucky
Location
facility University of Kentucky
Location Countries

United States

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: University of Kentucky

Investigator full name: Jens Rosenau

Investigator title: Associate Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Current Care Model (Control)

Arm group type: No Intervention

Description: The Current Care Model will not have any intervention beyond the standard of care for Hepatitis C provided by an interdisciplinary team at the University of Kentucky.

Arm group label: PREP-C Model

Arm group type: Experimental

Description: The PREP-C care model will provide Hepatitis C care with the standard interdisciplinary team expanded by a social worker and a patient navigator team. The social worker/ patient navigator team will use the standardized Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) tool and will guide PREP-C related interventions to overcome barriers to HCV treatment uptake and completion.

Arm group label: Modified ECHO Model

Arm group type: Experimental

Description: The modified Extension for Community Healthcare Outcomes (ECHO) Model will provide patient care through collaboration of the expanded interdisciplinary team (including social worker patient navigator team) with community providers.

Acronym CARE-C
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Factorial Assignment

Intervention model description: 3 Arms: Two intervention models plus a control group representing standard practice

Primary purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov