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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01143896
First received: June 11, 2010
Last updated: April 12, 2016
Last verified: April 2016
  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 VA Office of Research and Development:

Primary Outcome Measures:
  • Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Antiviral treatment initiation was measured dichotomously by assigning a value of 1 if the patient received at least one prescription of interferon within 12 months of enrollment, and a value of 0 otherwise.

  • Depression Care: Treatment Response [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression treatment response was defined as a 50% or greater decrease in the mean SCL-20 score compared with baseline.

  • Depression Care: Depression Remission [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Remission was defined as an item mean SCL-20 score of less than 0.5.

  • Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months [ Time Frame: From Baseline to 12 months ] [ Designated as safety issue: No ]
    The change in Depression Free Days was assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression-free days (DFDs) were calculated using an SCL-20 score of less than 0.5 for depression-free and 2.0 or higher for fully symptomatic, and scores in between were assigned a linear proportional value.


Secondary Outcome Measures:
  • Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Quality of CHC Indicator Measure is based on a Delphi panel-derived list of quality indicators (QI) in CHC care. The list spans the following domains of care, i.e., CHC-specific function of care (diagnosis, specialty evaluation, treatment, etc); general function of care (diagnosis, treatment, follow-up); and mode of care (encounter, medication, immunization, counseling, etc). Adherence to a given QI is scored as 1 if there is evidence in the patient EMR for the indicator being satisfied. The quality of CHC care at the patient level is calculated by dividing the number of QIs for which that individual received the indicated care by the number of QIs for which the individual is eligible for during the length of time the patient is enrolled in the HEP-TIDES 12-month study timeframe.

  • Medication Adherence: Medication Possession Ratio [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Medication adherence was measured using the Medication Possession Ratio (MPR) calculation: Pharmacy refill data was used to calculate a medication possession ratio (MPR), by dividing the number of days supply of a medication received by the number of day's supply the patient needed to be able to take the medication continuously. An MPR closer to 1.0 indicates better adherence and has been associated with lower rates of hospital admission in veterans and greater symptom improvement.


Enrollment: 309
Study Start Date: February 2012
Study Completion Date: November 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Depression Collaborative Care
Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a 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: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
Other: Depression collaborative care model
The intervention will include a stepped-care model. The 5 steps include symptom and self-management monitoring by a 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: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
No Intervention: Arm 2: Usual Care
Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.

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

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
VA Office of Research and Development
Investigators
Principal Investigator: Fasiha Kanwal, MBBS MD Michael E. DeBakey VA Medical Center, Houston, TX
Principal Investigator: Jeffrey M. Pyne, MD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Principal Investigator: Brian Dieckgraefe, MD St. Louis VA Medical Center John Cochran Division, St. Louis, MO
Principal Investigator: Matthew Goetz, MD VA Greater Los Angeles Healthcare System
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01143896     History of Changes
Other Study ID Numbers: SDP 10-044  10-05 
Study First Received: June 11, 2010
Results First Received: January 4, 2016
Last Updated: April 12, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Hepatitis C
Depression
Collaborative care
Antiviral treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Depression
Depressive Disorder
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Behavioral Symptoms
Mood Disorders
Mental Disorders
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 24, 2016