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Hepatitis C Translating Initiatives for
Depression Into Effective Solutions (HEPTIDES)
This study is currently recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01143896
First received: June 11, 2010
Last updated: November 1, 2012
Last verified: November 2012
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.
Hepatitis C
Depression
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Other: Depression
collaborative care model
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Study Type: |
Interventional
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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 |
Primary Outcome Measures:
-
Initiation of hepatitis C
antiviral treatment and depression severity [ Time
Frame: 12 months ] [ Designated as safety issue: No
]
Secondary Outcome Measures:
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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) |
Experimental: Arm 1
Depression collaborative care arm
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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.
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No Intervention: Arm 2
Usual care
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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).
Ages Eligible for Study: |
18 Years and older |
Genders Eligible for Study: |
Both |
Accepts Healthy Volunteers: |
No |
Inclusion
Criteria:
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confirmed untreated infection
(positive HCV RNA test)
-
current PHQ-9 score of 10 or
more
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current treatment in the CHC
clinic
Exclusion
Criteria:
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non-Veterans
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patients who do not have access
to a telephone
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patients with current suicidal
ideation
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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
Please refer to this study by its ClinicalTrials.gov identifier:
NCT01143896
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr,
Little Rock |
Little
Rock, Arkansas, United States, 72205-5484 |
Contact: Jeffrey Pyne, MD 501-257-1083
jeffrey.pyne@va.gov |
VA Greater Los Angeles Healthcare System, West Los
Angeles, CA |
West
Los Angeles, California, United States, 90073 |
Contact: Matthew Goetz, MD 310-268-3763
matthew.goetz@va.gov |
St. Louis VA Medical Center John Cochran Division, St.
Louis, MO |
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
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Michael E. DeBakey VA Medical Center, Houston, TX |
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
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Sub-Investigator: Hashem B. El-Serag, MD MPH
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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 |
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
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Keywords provided by Department of Veterans Affairs:
Hepatitis C
Depression
Collaborative care
Antiviral treatment
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Additional relevant MeSH terms:
Depression
Depressive Disorder
Hepatitis
Hepatitis A
Hepatitis C
Behavioral Symptoms
Mood Disorders
Mental Disorders
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Liver
Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
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ClinicalTrials.gov processed this record on
January 21, 2013
http://clinicaltrials.gov/ct2/show/NCT01143896
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