Clinical trial NCT02648022: Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
Official title: Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Depression
PTSD
Substance Use Disorder
Fibrosis
Keywords: Care Integration
Hepatitis C
Substance Use Disorder
PTSD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-01-06
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Sustained Viral Response (SVR)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Treatment Initiation and Completion
timeFrame: up to 24 weeks
measure: Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Samuel B Ho, MD
role: PRINCIPAL_INVESTIGATOR
References: