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

NCT02648022 | Completed Results

• 1 other identifier: IIR 07-101-A
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Depression; PTSD; Substance Use Disorder; Fibrosis

Keywords

Care Integration; Hepatitis C; Substance Use Disorder; PTSD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants With Treatment Initiation and Completion

  up to 24 weeks

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

  up to 24 weeks

Study Arms (2)

Integrated Care

EXPERIMENTAL

Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.

Behavioral: Brief mental health interventions and case management

Usual Care

NO INTERVENTION

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

Interventions

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.

Integrated Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Hepatitis C; Depression; Stress Disorders, Post-Traumatic; Substance-Related Disorders; Fibrosis

Interventions

Case Management

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Samuel B. Ho
• Organization: Va San Diego Healthcare System

Samuel.Ho2@va.gov

858-552-8585

Study Officials

• Samuel B Ho, MD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2014
• Last Updated: May 20, 2016
• Results First Posted: May 20, 2016

Record last verified: 2016-05

Locations

US (1)