Overview

This trial is active, not recruiting.

Conditions hepatitis c, depression
Treatment depression collaborative care model
Sponsor Department of Veterans Affairs
Start date February 2012
End date September 2014
Trial size 309 participants
Trial identifier NCT01143896, 10-05, SDP 10-044

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Depression collaborative care arm
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.
(No Intervention)
Usual care

Primary Outcomes

Measure
Initiation of hepatitis C antiviral treatment and depression severity
time frame: 12 months

Secondary Outcomes

Measure
Quality of hepatitis C care
time frame: 12 months
Medication adherence
time frame: 6 and 12 months
Quality of depression care
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Hepatitis C Translating Initiatives for Depression Into Solutions
Principal investigator Fasiha Kanwal, MBBS MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.