Hepatitis C Translating Initiatives for Depression Into Effective Solutions (HEPTIDES)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01143896
First received: June 11, 2010
Last updated: July 22, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 309
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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
  • patients with a chart diagnosis of bipolar disorder who have been hospitalized for a mental health condition within the last 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
Little Rock, Arkansas, United States, 72205-5484
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
United States, Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States, 63106
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Fasiha Kanwal, MBBS MD Michael E DeBakey VA Medical Center
Principal Investigator: Jeffrey M. Pyne, MD Central Arkansas Veterans Healthcare System (North 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, SDP 10-044, 10-05
Study First Received: June 11, 2010
Last Updated: July 22, 2014
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 August 26, 2014