Clinical trial NCT01143896: Hepatitis C Translating Initiatives for Depression Into Effective Solutions
Official title: Hepatitis C Translating Initiatives for Depression Into Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Depression
Keywords: Hepatitis C
Depression
Collaborative care
Antiviral treatment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-06-14
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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 242 patients (aims 2 and 3).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment
timeFrame: 12 months
measure: Depression Care: Treatment Response
timeFrame: Baseline and 12 months
measure: Depression Care: Depression Remission
timeFrame: Baseline and 12 months
measure: Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months
timeFrame: From Baseline to 12 months
Secondary outcomes:
measure: Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received
timeFrame: 12 months
measure: Medication Adherence: Medication Possession Ratio
timeFrame: 12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
state: Arkansas
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: St Louis
country: United States
facility: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
state: Missouri
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Fasiha Kanwal, MBBS MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: Jeffrey M. Pyne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
name: Brian Dieckgraefe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System
name: Matthew Goetz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pyne JM. Expanding the Scope of Integrated Behavioral Health Care for Patients With Hepatitis C Virus. Clin Gastroenterol Hepatol. 2015 Nov;13(11):2015-6. doi: 10.1016/j.cgh.2015.04.174. Epub 2015 May 5. No abstract available.
citation: Zuchowski JL, Hamilton AB, Pyne JM, Clark JA, Naik AD, Smith DL, Kanwal F. Qualitative analysis of patient-centered decision attributes associated with initiating hepatitis C treatment. BMC Gastroenterol. 2015 Oct 1;15:124. doi: 10.1186/s12876-015-0356-5.
citation: Kanwal F, Pyne JM, Tavakoli-Tabasi S, Nicholson S, Dieckgraefe B, Storay E, Bidwell Goetz M, Smith DL, Sansgiry S, Gifford A, Asch SM. Collaborative Care for Depression in Chronic Hepatitis C Clinics. Psychiatr Serv. 2016 Oct 1;67(10):1076-1082. doi: 10.1176/appi.ps.201400474. Epub 2016 Jul 1.