Community Access, Retention in Care, and Engagement for Hepatitis C Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional

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.
    

Intervention name(s): PREP-C; Modified ECHO; Patient Telemedicine Questionnaire
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; The patient questionnaire includes questions about patient experiences with telemedicine visits with providers
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 telemedicine
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Hepatitis C; Hep C; CARE-C; Kentucky