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

Not Applicable

Completed

• Conditions: Depression; Substance Use Disorder; Fibrosis; Hepatitis C; PTSD
• Interventions: Behavioral: Brief mental health interventions and case management

• Registration Number: NCT02648022
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-01
• Study Completion: 2014-02
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Status Verified: 2016-05
• Results First Submitted: 2016-05-05
• Results First Submitted QC: 2016-05-05
• Last Update Submitted: 2016-05-05
• Results First Posted: 2016-05-20
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Care	Brief mental health interventions and case management	Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.

Primary Outcome Measures

Name	Time	Method
Sustained Viral Response (SVR)	up to 24 weeks	The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Initiation and Completion	up to 24 weeks	The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%	up to 24 weeks	Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States