Back to resultsIntegrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
Primary Purpose
Hepatitis C, Depression, PTSD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief mental health interventions and case management
Sponsored by
About this trial
This is an interventional health services research trial for Hepatitis C focused on measuring Care Integration, Hepatitis C, Substance Use Disorder, PTSD
Eligibility Criteria
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
Sites / Locations
- VA San Diego Healthcare System, San Diego, CA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Integrated Care
Usual Care
Arm Description
Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02648022
First Posted
December 21, 2015
Last Updated
May 5, 2016
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02648022
Brief Title
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
Official Title
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Depression, PTSD, Substance Use Disorder, Fibrosis
Keywords
Care Integration, Hepatitis C, Substance Use Disorder, PTSD
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Integrated Care
Arm Type
Experimental
Arm Description
Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Brief mental health interventions and case management
Intervention Description
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 Outcome Measure Information:
Title
Sustained Viral Response (SVR)
Description
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.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Treatment Initiation and Completion
Description
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.
Time Frame
up to 24 weeks
Title
Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
Description
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.
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel B Ho, MD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
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