VA Clinical trial HCV & Depression

Purpose

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.

Condition	Intervention
Hepatitis C Depression	Other: Depression collaborative care model

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Hepatitis C Translating Initiatives for Depression Into Solutions

Resource links provided by NLM:

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Initiation of hepatitis C antiviral treatment and depression severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Antiviral treatment completion [ Time Frame: Within 24 months of treatment completion ] [ Designated as safety issue: No ]
Quality of hepatitis C care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Treatment satisfaction [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Medication adherence [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Quality of depression care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Alcohol and street drug use [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	February 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Experimental: Arm 1

Depression collaborative care arm

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.

No Intervention: Arm 2

Usual care

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 268 patients (aims 2 and 3). Towards the end of the project we will evaluate the cost-effectiveness of HEP-TIDES defining incremental cost-effectiveness in terms of cost per additional CHC treatment initiation and cost per additional CHC treatment completion (exploratory aim).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 or bipolar disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143896

Contacts

Contact: Donna L Smith, MEd	(713) 791-1414 ext 6909	Donna.Smithd19d7@va.gov
Contact: Fasiha Kanwal, MBBS MD	(713) 794-8688	Fasiha.Kanwal@va.gov

Locations

United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	Recruiting
Little Rock, Arkansas, United States, 72205-5484
Contact: Jeffrey Pyne, MD 501-257-1083 jeffrey.pyne@va.gov
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA	Recruiting
West Los Angeles, California, United States, 90073
Contact: Matthew Goetz, MD 310-268-3763 matthew.goetz@va.gov
United States, Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO	Recruiting
St Louis, Missouri, United States, 63106
Contact: Donna L Smith, MEd (713) 791-1414 ext 6909 Donna.Smithd19d7@va.gov
Principal Investigator: Peter Anthony Brawer, PhD
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX	Recruiting
Houston, Texas, United States, 77030
Contact: Donna L Smith, MEd 713-791-1414 ext 6909 Donna.Smithd19d7@va.gov
Contact: Fasiha Kanwal, MBBS MD (713) 794-8688 Fasiha.Kanwal@va.gov
Principal Investigator: Fasiha Kanwal, MBBS MD
Sub-Investigator: Hashem B. El-Serag, MD MPH

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:	Fasiha Kanwal, MBBS MD	Michael E DeBakey VA Medical Center
Principal Investigator:	Jeffrey M. Pyne, MD	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
Principal Investigator:	Peter Anthony Brawer, PhD	St. Louis VA Medical Center John Cochran Division, St. Louis, MO

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT01143896 History of Changes
Other Study ID Numbers:	SDP 10-044
Study First Received:	June 11, 2010
Last Updated:	November 1, 2012
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Hepatitis C
Depression
Collaborative care
Antiviral treatment

Additional relevant MeSH terms:

Depression
Depressive Disorder
Hepatitis
Hepatitis A
Hepatitis C
Behavioral Symptoms
Mood Disorders
Mental Disorders

Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 21, 2013
http://clinicaltrials.gov/ct2/show/NCT01143896