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

NCT03581383 | Completed

• 1 other identifier: 17-0812-F2L
• Study Type: interventional
• Target: 657
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Hepatitis C; Hep C; CARE-C; Kentucky

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Missed clinic visits

  18 months

• Clinic visit consistency

  18 months

• Gaps in clinical care

  18 months

• Appointment adherence

  18 months

• Visit frequency within a twelve month period

  18 months

Study Arms (4)

Current Care Model (Control)

NO INTERVENTION

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.

PREP-C Model

EXPERIMENTAL

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

Modified ECHO Model

EXPERIMENTAL

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; Behavioral: Modified ECHO

Telemedicine Arm

EXPERIMENTAL

The telemedicine Model will track outcomes and record patient experiences with HCV management and treatment with telemedicine.

Behavioral: Patient Telemedicine Questionnaire

Interventions

PREP-C BEHAVIORAL

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.

Modified ECHO Model; PREP-C Model

Modified ECHO BEHAVIORAL

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.

Modified ECHO Model

Patient Telemedicine Questionnaire BEHAVIORAL

The patient questionnaire includes questions about patient experiences with telemedicine visits with providers

Telemedicine Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Life expectancy less than one year
• Less than 18 years old

Sponsors & Collaborators

• Jens Rosenau: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Jens Rosenau, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 3 Arms: Two intervention models plus a control group representing standard practice Arm 4: And intervention model to record patient experiences with telemedicine

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 10, 2018
• Study Start: August 21, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)