Community Access, Retention in Care, and Engagement for Hepatitis C Treatment (CARE-C)

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Behavioral: PREP-C; Behavioral: Modified ECHO; Behavioral: Patient Telemedicine Questionnaire

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.

• Study Type: Interventional
• Enrollment (Actual): 657
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Current Care Model (Control); 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.
Experimental: PREP-C Model; 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.	Behavioral: PREP-C; 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.
Experimental: Modified ECHO Model; 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.	Behavioral: PREP-C; 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.; Behavioral: Modified ECHO; 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.
Experimental: Telemedicine Arm; The telemedicine Model will track outcomes and record patient experiences with HCV management and treatment with telemedicine.	Behavioral: Patient Telemedicine Questionnaire; The patient questionnaire includes questions about patient experiences with telemedicine visits with providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV treatment initiation	The overall number of patients who have started HCV treatment by month12 after the first clinic visit will be divided by the number of patients enrolled and presented as a percentage of participants per group.	12 months
HCV treatment completion	The number of patients who have completed HCV treatment will be divided by the number of patients who have started treatment and presented as a percentage of participants per group.	12 months
Sustained Virologic Response (SVR)	The number of patients who achieve sustained virologic response (negative HCV RNA 12 weeks after completion of HCV treatment) will be divided by the number of patients who have started treatment and presented as a percentage of participants per group.	12 weeks from treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Missed clinic visits	The total number of missed clinic visits will be counted for each group. Data will be presented as the number of missed visits divided by the number of total visits scheduled and presented as a percentage of total clinic appointments.	18 months
Clinic visit consistency	This outcome will measure the number of participants attending clinical visits with less than six month intervals between visits. Data will be presented as the number of participants maintaining an appointment interval less than six months divided by the total number of participants.	18 months
Gaps in clinical care	The average time between clinical appointments will be calculated between groups. Data will be presented as the mean amount of time +/- SEM.	18 months
Appointment adherence	This outcome will measure the number of clinical appointments the participant attended compared to the number of appointments they were scheduled to attend. Data presented as the ratio of attended/scheduled appointments	18 months
Visit frequency within a twelve month period	This outcome will track the number of participants attending two or more clinical appointments in a 12 month period with at least 3 months between visits. Data will be presented as the ratio of participants in each group attending multiple visits compared to the total number of participants in each group.	18 months

Collaborators and Investigators

• Sponsor: Jens Rosenau
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Jens Rosenau, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Hepatitis C; Hep C; Kentucky; CARE-C
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 17-0812-F2L

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No