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

Sponsor

Jens Rosenau (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03581383

Collaborator

Gilead Sciences (Industry)

657

Enrollment

Location

Arms

48.4

Anticipated Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Behavioral: PREP-C Behavioral: Modified ECHO Behavioral: Patient Telemedicine Questionnaire	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

657 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

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 telemedicine3 Arms: Two intervention models plus a control group representing standard practice Arm 4: And intervention model to record patient experiences with telemedicine

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Aug 21, 2018

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

HCV treatment initiation [12 months]
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.
HCV treatment completion [12 months]
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.
Sustained Virologic Response (SVR) [12 weeks from treatment completion]
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.

Secondary Outcome Measures

Missed clinic visits [18 months]
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.
Clinic visit consistency [18 months]
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.
Gaps in clinical care [18 months]
The average time between clinical appointments will be calculated between groups. Data will be presented as the mean amount of time +/- SEM.
Appointment adherence [18 months]
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
Visit frequency within a twelve month period [18 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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