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

NCT ID: NCT02648022

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-02-28

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Integrated Care

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

Group Type: EXPERIMENTAL

Brief mental health interventions and case management

Intervention Type: BEHAVIORAL

The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brief mental health interventions and case management

The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel B Ho, MD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Countries

United States

Other Identifiers

IIR 07-101-A

Identifier Type: -

Identifier Source: org_study_id