Hepatitis C Translating Initiatives for Depression Into Effective Solutions

NCT ID: NCT01143896

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-11-30

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).

Conditions

Hepatitis C; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Depression collaborative care model

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fasiha Kanwal, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center, Houston, TX

Jeffrey M. Pyne, MD

Role: PRINCIPAL_INVESTIGATOR

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Brian Dieckgraefe, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

Matthew Goetz, MD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System

Locations

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

Little Rock, Arkansas, United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25952310 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26429337 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27364808 (View on PubMed)

Other Identifiers

10-05

Identifier Type: OTHER

Identifier Source: secondary_id

SDP 10-044

Identifier Type: -

Identifier Source: org_study_id