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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment

Conditions
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Hepatitis C, Depression, PTSD, Substance Use Disorder, Fibrosis

Intervention / Treatment
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* Behavioral: Brief mental health interventions and case management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Care<br>Consisted of brief mental health interventions and case management provided in a collaborative treatment environment. | Behavioral: Brief mental health interventions and case management<br>* 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.<br>|
| No Intervention: Usual Care<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Viral Response (SVR) | 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. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment Initiation and Completion | 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. | up to 24 weeks | 
| Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80% | 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. | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Care Integration, Hepatitis C, Substance Use Disorder, PTSD