Hepatitis CHEPTIDESNCT01143896

Hepatitis C Translating Initiatives for Depression Into Effective Solutions

A study testing Depression collaborative care model in people with Hepatitis C and Depression, run by VA Office of Research and Development at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hepatitis C, Depression
What is being tested?: Depression collaborative care model
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 309 participants
Where: 4 sitesUnited States
Study dates: Feb 2012to Nov 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
Little Rock, Arkansas, 72205-5484
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073

Other trials in United States

About this study

Official title: Hepatitis C Translating Initiatives for Depression Into Solutions

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.

Read the 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
Being tested: Depression collaborative care model
Keywords: Hepatitis C, Depression, Collaborative care, Antiviral treatment
Medical subject headings: Hepatitis C, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Depression collaborative care modelOther
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.

Study groups in NCT01143896
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline to 12 months

Secondary outcomes (2)

Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received
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.
Measured: 12 months
Medication Adherence: Medication Possession Ratio
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Nov 2015

First posted14 Jun 2010 (estimated)
Study startFeb 2012
Primary completionSep 2014
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 309 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01143896
Sponsor's protocol ID: SDP 10-044
Other IDs: 10-05
Acronym: HEPTIDES
Status last verified: Apr 2016
First submitted: 11 Jun 2010
Last updated: 16 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 25952310
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.
PubMed 26429337
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.
PubMed 27364808

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hepatitis C Translating Initiatives for Depression Into Solutions
ClinicalTrials.gov ID: NCT01143896
Acronym / sponsor ID: HEPTIDES / SDP 10-044
Conditions: Hepatitis C, Depression
Keywords: Hepatitis C, Depression, Collaborative care, Antiviral treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 309 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Feb 2012
Primary completion: Sep 2014 (actual)
Study completion: Nov 2015 (actual)
First posted: 14 Jun 2010 (estimated)
Results: Posted 11 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1: Depression Collaborative Care	Experimental	Other: Depression collaborative care modelDepression 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.
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.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Depression collaborative care modelThe 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.	Other	Arm 1: Depression Collaborative Care

Primary outcome

Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment
Time frame: 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.
Depression Care: Treatment Response
Time frame: 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.
Depression Care: Depression Remission
Time frame: 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.
Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months
Time frame: 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.

2 secondary outcomes

Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received
Time frame: 12 months
Medication Adherence: Medication Possession Ratio
Time frame: 12 months

Results and safety

Results posted to the registry on 11 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Depression Collaborative Care	156	114
Arm 2: Usual Care	153	128

Primary outcome: Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment

Time frame: 12 months. Number. Unit: participants

Measure	Arm 1: Depression Collaborative Care n = 114	Arm 2: Usual Care n = 128
Value	11	7

Population analysed: intent to treat

Primary outcome: Depression Care: Treatment Response

Time frame: Baseline and 12 months. Number. Unit: participants

Measure	Arm 1: Depression Collaborative Care n = 114	Arm 2: Usual Care n = 128
Value	36	19

Primary outcome: Depression Care: Depression Remission

Time frame: Baseline and 12 months. Number. Unit: participants

Measure	Arm 1: Depression Collaborative Care n = 114	Arm 2: Usual Care n = 128
Value	22	9

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

Time frame: From Baseline to 12 months. Mean (Standard Deviation). Unit: Depression Free Days (DFDs)

Measure	Arm 1: Depression Collaborative Care n = 114	Arm 2: Usual Care n = 128
Value	118.74 (106.68)	109.30 (117.88)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Depression Collaborative Care	6 of 145 (4.1%)	0 of 145 (0%)	Not reported
Arm 2: Usual Care	3 of 147 (2%)	0 of 147 (0%)	Not reported

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25952310Pyne 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.
Results publication: PubMed 26429337Zuchowski 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.
Derived from this study: PubMed 27364808Kanwal 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.

Related trials for Hepatitis C

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fasiha Kanwal, MBBS MD principal investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Jeffrey M. Pyne, MD principal investigator

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

Brian Dieckgraefe, MD principal investigator

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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Depression collaborative care model in people with Hepatitis C and Depression, run by VA Office of Research and Development at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01143896, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.