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Completed

NCT Number: NCT02648022

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

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.

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Key information

Conditions

Hepatitis C Behavior Behavioral Symptoms Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Depression Digestive System Diseases Fibrosis Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders PTSD Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance Use Disorder Substance-Related Disorders Trauma and Stressor Related Disorders Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief mental health interventions and case management

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.

Primary outcomes

  1. Sustained Viral Response (SVR)

    Time frame: 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 outcomes

  1. Percentage of Participants With Treatment Initiation and Completion

    Time frame: 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.

  2. Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 6, 2016
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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