Hepatitis C Translating Initiatives for Depression Into Effective Solutions

NCT01143896 | Completed Results DMC

• 2 other identifiers: SDP 10-04410-05
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatitis C; Depression

Keywords

Hepatitis C; Depression; Collaborative care; Antiviral treatment

Outcome Measures

Primary Outcomes (4)

• Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment

  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.

  12 months

• Depression Care: Treatment Response

  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.

  Baseline and 12 months

• Depression Care: Depression Remission

  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.

  Baseline and 12 months

• Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months

  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.

  From Baseline to 12 months

Secondary Outcomes (2)

• Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received

  12 months

• Medication Adherence: Medication Possession Ratio

  12 months

Study Arms (2)

Arm 1: Depression Collaborative Care

EXPERIMENTAL

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

Arm 2: Usual Care

NO INTERVENTION

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.

Interventions

Depression collaborative care model 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 1: Depression Collaborative Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed untreated infection (positive HCV RNA test)
• current PHQ-9 score of 10 or more
• current treatment in the CHC clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

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

Little Rock, Arkansas, 72205-5484, United States

Location

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

West Los Angeles, California, 90073, United States

Location

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

St Louis, Missouri, 63106, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 25952310 RESULT

• 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.

  PMID: 26429337 RESULT

• 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.

  PMID: 27364808 DERIVED

MeSH Terms

Conditions

Hepatitis C; Depression

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior

Limitations and Caveats

Primary Outcome Initiation of HCV treatment was affected by the 2012 announcement that new interferon-sparing antiviral drugs might be released within 1 year. Most HCV clinicians advised patients to wait for the new drugs (released in 2014).

Results Point of Contact

• Title: Fasiha Kanwal, MD, MSHS
• Organization: Michael E. DeBakey VA Medical Center

Fasiha.Kanwal@va.gov

(713) 440-4495

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: February 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2015
• Last Updated: May 16, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-04

Locations

US (4)