Registry-based HCV Care Cascade Navigation at Atlanta's Grady Memorial Hospital

Summary

This study seeks to implement and evaluate a data-driven case navigation system for hepatitis C virus (HCV) treatment among persons who are either actively injecting drugs or who are receiving opioid substitution therapy (OST). The study will use data from a previously developed patient registry system to identify patients for study recruitment, and use monthly updates of registry data to organize and direct patient navigation services for those individuals assigned to the treatment group. Patients assigned to the control group will also be eligible to receive HCV treatment, but will otherwise receive usual care.

This study has a parallel, randomized unblinded, case/control design in which eligible patients are assigned at baseline to either a registry-directed patient navigation system (case) or to usual care (control), characterized in terms of demographic and sub-population variables, and then compared after 12 months on two categories of outcomes; (1) attainment of care cascade milestones; and (2) treatment initiation, adherence, and virologic response. The study is designed and powered to answer two primary hypotheses (H1 \& H2):

* H1: As compared to those randomized to usual care (control), those randomized to the registry directed patient navigation arm (case) will be more likely to complete all pretreatment HCV care milestones as defined by a higher proportion completing all four pre-treatment care cascade outcomes.
* H2: As compared to the control group, a significantly higher proportion of those randomized to the case group will achieve a sustained viral response.

Conditions

• Hepatitis C

Interventions

BEHAVIORAL

Data-assisted Case Navigation

The researchers will develop a monthly task list for the patient navigator with patient by patient care cascade and treatment milestones that need to be accomplished per patient in the case group. The researchers will deliver the spreadsheet and the task list to the Grady Liver Clinic Director who will use it to direct and supervise the activities of the patient navigator. Patient navigators will be responsible for reaching out to patients in only the intervention arm about their next step in the HCV care cascade.

BEHAVIORAL

Standard of Care

Patients will be recruited into the study by the patient navigator, be provided information about HCV infection, and will be informed that treatment is freely available should they seek it. Patients will also be provided contact and address information for the treatment clinic.

Sponsors & Collaborators

• Grady Health System

  collaborator OTHER

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Emory University

  collaborator OTHER

• National Opinion Research Center

  lead OTHER

Principal Investigators

• David Rein, Ph.D. · NORC at the University of Chicago

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-23

Primary Completion

2018-12-15

Completion

2019-02-15

Countries

• United States

Study Locations