Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment

VA Office of Research and Development

Status: Completed

Conditions: PTSD; Hepatitis C; Substance Use Disorder; Depression; Fibrosis

Treatments: Behavioral: Brief mental health interventions and case management

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02648022

IIR 07-101-A

Details and patient eligibility

About

To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.

Full description

Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a new era of more effective treatments for hepatitis C (HCV). The impact of more effective therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (SUD).

Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and provided brief mental health care and case management.

Enrollment: 83 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic

• All patients 18 and 75 years old with confirmed HCV infection

• Patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate

• Screening measures and cutoffs for inclusion were depression:

  • Beck Depression Inventory: (BDI) > 10
  • Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) > 4
  • PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any single endorsement of item #3
  • Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6 months prior to screen

Exclusion criteria

• Lacked a confirmed test of HCV RNA
• Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic)
• Had Hepatitis B (HBV) co-infection
• Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C
• Had other significant near term life-threatening diseases
• Were treatment non-responders with pegylated Interferon plus ribavirin

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Integrated Care

Experimental group

Description:

Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.

Treatment:

Behavioral: Brief mental health interventions and case management

Usual Care

No Intervention group

Description:

The usual care group received "standard of care" required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist