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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648022
• Other study ID #: IIR 07-101-A
• Status: Completed
• Phase: N/A
• First received: December 21, 2015
• Last updated: January 4, 2016
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Fibrosis
• Hepatitis
• Hepatitis C
• Mental Disorders
• PTSD
• Substance Use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Treatment initiation and completion rates	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	No