Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03581383 |
| Other study ID # |
17-0812-F2L |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 21, 2018 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
University of Kentucky |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
