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

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ClinicalTrials.gov Identifier: NCT03581383
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jens Rosenau, 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).

Condition or disease Intervention/treatment Phase
Hepatitis C Behavioral: PREP-C Behavioral: Modified ECHO Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 3 Arms: Two intervention models plus a control group representing standard practice
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 : August 21, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. HCV treatment initiation [ Time Frame: 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.

  2. HCV treatment completion [ Time Frame: 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.

  3. Sustained Virologic Response (SVR) [ Time Frame: 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 :
  1. Missed clinic visits [ Time Frame: 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.

  2. Clinic visit consistency [ Time Frame: 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.

  3. Gaps in clinical care [ Time Frame: 18 months ]
    The average time between clinical appointments will be calculated between groups. Data will be presented as the mean amount of time +/- SEM.

  4. Appointment adherence [ Time Frame: 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

  5. Visit frequency within a twelve month period [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581383


Contacts
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Contact: Courtney Hammill, MS 859-323-7942 courtney.hammill@uky.edu
Contact: Tammi Gausepohl, MHA 859-257-3383 tammi.gausepohl@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Courtney Hammill, MS         
Sponsors and Collaborators
Jens Rosenau
Investigators
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Principal Investigator: Jens Rosenau, MD University of Kentucky

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Responsible Party: Jens Rosenau, Associate Professor of Medicine, University of Kentucky
ClinicalTrials.gov Identifier: NCT03581383     History of Changes
Other Study ID Numbers: 17-0812-F2L
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jens Rosenau, University of Kentucky:
Hepatitis C
Hep C
CARE-C
Kentucky

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections