HEPTIDES: Hepatitis C Translating Initiatives for Depression Into Effective Solutions

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01143896
• Collaborator: (none)
• Enrollment: 309
• Locations: 4
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 77.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C; Depression	Other: Depression collaborative care model	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 309 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Hepatitis C Translating Initiatives for Depression Into Solutions
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment [12 months]

   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.

2. Depression Care: Treatment Response [Baseline and 12 months]

   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.

3. Depression Care: Depression Remission [Baseline and 12 months]

   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.

4. Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months [From Baseline to 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.

Secondary Outcome Measures

1. Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received [12 months]

   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.

2. Medication Adherence: Medication Possession Ratio [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	Little Rock	Arkansas	United States	72205-5484
2	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California	United States	90073
3	St. Louis VA Medical Center John Cochran Division, St. Louis, MO	St Louis	Missouri	United States	63106
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01143896
• Other Study ID Numbers: SDP 10-044; 10-05
• First Posted: Jun 14, 2010
• Last Update Posted: May 16, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by VA Office of Research and Development: Hepatitis C; Depression; Collaborative care; Antiviral treatment
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Depression; Depressive Disorder

Study Results

Participant Flow

Recruitment Details	We recruited a total of 309 patients from CHC clinics at 4 VAs (Houston, St Louis, Little Rock, and Los Angeles) between April 2012 and September 2013. Of these, 292 patients completed baseline interviews. Follow-up data-collection interviews were completed for 263 (90.1%) participants at 6-months and 242 (78.3%) participants at 12-months.

Arm/Group Title	Arm 1: Depression Collaborative Care	Arm 2: Usual Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	156	153
COMPLETED	114	128
NOT COMPLETED	42	25

Baseline Characteristics

Arm/Group Title	Arm 1: Depression Collaborative Care	Arm 2: Usual Care	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	145	147	292
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (5.8)	59 (5.2)	59 (5.5)
Sex: Female, Male (Count of Participants)
Female	6 4.1%	6 4.1%	12 4.1%
Male	139 95.9%	141 95.9%	280 95.9%
Race/Ethnicity, Customized (participants) [Number]
White Non-Hispanic	59 40.7%	41 27.9%	100 34.2%
Black or African American	72 49.7%	91 61.9%	163 55.8%
Other	14 9.7%	15 10.2%	29 9.9%
Region of Enrollment (participants) [Number]
United States	145 100%	147 100%	292 100%
Marital Status (participants) [Number]
Single, Never Married	45 31%	68 46.3%	113 38.7%
Married	14 9.7%	16 10.9%	30 10.3%
Other (divorced, widowed, separated, no response)	86 59.3%	63 42.9%	149 51%
Annual Income (participants) [Number]
Less than $20,000	60 41.4%	57 38.8%	117 40.1%
Over $20,000	43 29.7%	41 27.9%	84 28.8%
Don't Know/Refused	42 29%	49 33.3%	91 31.2%
History of Mood Disorders (participants) [Number]
Yes	65 44.8%	67 45.6%	132 45.2%
No	80 55.2%	78 53.1%	158 54.1%
Don't Know/Refused	0 0%	2 1.4%	2 0.7%
Taking antidepressant meds at baseline (participants) [Number]
Yes	71 49%	67 45.6%	138 47.3%
No	71 49%	79 53.7%	150 51.4%
Don't Know/Refused	3 2.1%	1 0.7%	4 1.4%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

intent to treat

Arm/Group Title	Arm 1: Depression Collaborative Care	Arm 2: Usual Care
Arm/Group Description	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.	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.
Measure Participants	114	128
Number [participants]	11 7.6%	7 4.8%

2. Secondary Outcome

Title	Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Depression Collaborative Care	Arm 2: Usual Care
Arm/Group Description	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.	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.
Measure Participants	114	128
Mean (Standard Deviation) [proportion of QIs met]	.89 (.16)	.83 (.19)

3. Secondary Outcome

Title	Medication Adherence: Medication Possession Ratio
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Depression Collaborative Care	Arm 2: Usual Care
Arm/Group Description	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.	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.
Measure Participants	114	128
Mean (Standard Deviation) [medication posession ratio]	.83 (.20)	.78 (.24)

4. Primary Outcome

Title	Depression Care: Treatment Response
Description	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.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Depression Collaborative Care	Arm 2: Usual Care
Arm/Group Description	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.	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.
Measure Participants	114	128
Number [participants]	36 24.8%	19 12.9%

5. Primary Outcome

Title	Depression Care: Depression Remission
Description	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.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Depression Collaborative Care	Arm 2: Usual Care
Arm/Group Description	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.	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.
Measure Participants	114	128
Number [participants]	22 15.2%	9 6.1%

6. Primary Outcome

Title	Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months
Description	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.
Time Frame	From Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Depression Collaborative Care	Arm 2: Usual Care
Arm/Group Description	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.	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.
Measure Participants	114	128
Mean (Standard Deviation) [Depression Free Days (DFDs)]	118.74 (106.68)	109.30 (117.88)

Adverse Events

Time Frame	12 months
Arm/Group Title	Arm 1: Depression Collaborative Care		Arm 2: Usual Care
Arm/Group Description	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.		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.
All Cause Mortality
	Arm 1: Depression Collaborative Care		Arm 2: Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1: Depression Collaborative Care		Arm 2: Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/145 (4.1%)		3/147 (2%)
General disorders
Death (IRB determined unrelated to the study)	6/145 (4.1%)	6	3/147 (2%)	3
Other (Not Including Serious) Adverse Events
	Arm 1: Depression Collaborative Care		Arm 2: Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/145 (0%)		0/147 (0%)

Limitations/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).

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.