Hepatitis C Translating Initiatives for Depression Into Effective Solutions

Depression Clinical Trial

— HEPTIDES  

Official title:

Hepatitis C Translating Initiatives for Depression Into Solutions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01143896
• Other study ID #: SDP 10-044
• Secondary ID: SDP 10-04410-05
• Status: Active, not recruiting
• Phase: N/A
• First received: June 11, 2010
• Last updated: May 8, 2015
• Start date: February 2012
• Est. completion date: September 2016

Study information

• Verified date: May 2015
• 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

Chronic infection with hepatitis C (CHC) is a common and expensive condition, and it disproportionately affects veterans. Treatment with antiviral therapy reduces liver disease progression and improves health related quality of life. However, ~70% of veterans with CHC are considered ineligible for antiviral treatment. Most of these patients are excluded due to the presence of co-existing depression and substance use. The proposed project will adapt and adopt an evidence-based collaborative depression care model in CHC clinics. By removing the leading contraindication for antiviral treatment, this project will potentially yield benefits that go far beyond the obvious quality of life benefit from antidepressant therapy itself.

Description:

Project Background and Rationale: Depression is highly prevalent, yet under-diagnosed and under-treated in CHC. Treatment models that increase collaborative management of depression by mental health and physical health clinicians can improve quality and outcomes, and collaborative care models have been identified as the best-practice for depression in VA primary care settings. However, the antiviral treatment for CHC patients may not benefit from the existing primary care-mental health integration because the antiviral treatment is time-limited and conducted in specialty clinics. Although there is little evidence evaluating the effects of collaborative depression care in specialty settings, QUERI HIV-hepatitis initiated one of the first such efforts that effectively implemented collaborative depression care in HIV clinics. Built on this experience, an intensive yet focused collaborative care model in CHC clinics may be effective in improving not only depression but also CHC care. This proposed study, "Hepatitis-Translating Initiatives for Depression into Effective Solutions (HEP-TIDES)" will target this issue.

Project Objectives: The proposal has three overarching primary aims and one exploratory aim. The primary aims are (1) adapt and adopt the collaborative care model for improving depression care in specialty CHC care settings, (2) compare the effectiveness of HEP-TIDES to usual care in improving CHC care, and (3) compare the effectiveness of HEP-TIDES to usual care in improving depression care. The exploratory aim is to evaluate the cost-effectiveness of HEP-TIDES versus usual care.

Project Methods: HEP-TIDES is a multi-site, multi-method implementation project. HEP-TIDES will use evidence-based quality improvement (EBQI) methods to adapt and implement depression screening and the collaborative care model for depression in the CHC clinics at 4 disparate VA facilities (aim 1). HEP-TIDES will involve CHC and mental health providers working with an off-site depression care team comprised of a depression care nurse manager, pharmacist, and a psychiatrist. The purpose of the team will be to support CHC and mental health clinicians in delivering evidence-based stepped-care depression treatment. The adapted model will also take into account the substance use disorders among CHC patients. HEP-TIDES implementation will be assessed using a formative evaluation of the implementation process and a summative evaluation of a randomized controlled implementation trial of collaborative depression care in 268 patients (aims 2 and 3).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 309
• Est. completion date: September 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• confirmed untreated infection (positive HCV RNA test)

• current PHQ-9 score of 10 or more

• current treatment in the CHC clinic

Exclusion Criteria:

• non-Veterans

• patients who do not have access to a telephone

• patients with current suicidal ideation

• patients with significant cognitive impairment as indicated by a score > 10 on the Blessed Orientation Memory and Concentration Test

• patients with a chart diagnosis of schizophrenia

• patients with a chart diagnosis of bipolar disorder who have been hospitalized for a mental health condition within the last 12 months

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
• Depressive Disorder
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Other:
• Depression collaborative care model
The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
United States	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	Little Rock	Arkansas
United States	St. Louis VA Medical Center John Cochran Division, St. Louis, MO	St Louis	Missouri
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	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	Initiation of hepatitis C antiviral treatment and depression severity		12 months	No
Secondary	Quality of hepatitis C care		12 months	No
Secondary	Medication adherence		6 and 12 months	No
Secondary	Quality of depression care		12 months	No