Trial Outcomes & Findings for Hepatitis C Translating Initiatives for Depression Into Effective Solutions (NCT NCT01143896)
NCT ID: NCT01143896
Last Updated: 2016-05-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
309 participants
Primary outcome timeframe
12 months
Results posted on
2016-05-16
Participant Flow
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.
Participant milestones
| Measure |
Arm 1: Depression Collaborative Care
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
156
|
153
|
|
Overall Study
COMPLETED
|
114
|
128
|
|
Overall Study
NOT COMPLETED
|
42
|
25
|
Reasons for withdrawal
| Measure |
Arm 1: Depression Collaborative Care
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.
|
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.
|
|---|---|---|
|
Overall Study
Did not complete Baseline Interview
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
18
|
13
|
|
Overall Study
Withdrawal by Subject
|
13
|
5
|
|
Overall Study
Death
|
6
|
3
|
Baseline Characteristics
Hepatitis C Translating Initiatives for Depression Into Effective Solutions
Baseline characteristics by cohort
| Measure |
Arm 1: Depression Collaborative Care
n=145 Participants
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.
|
Arm 2: Usual Care
n=147 Participants
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
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
59 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
59 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
59 participants
n=5 Participants
|
41 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
72 participants
n=5 Participants
|
91 participants
n=7 Participants
|
163 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
145 participants
n=5 Participants
|
147 participants
n=7 Participants
|
292 participants
n=5 Participants
|
|
Marital Status
Single, Never Married
|
45 participants
n=5 Participants
|
68 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Marital Status
Married
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Marital Status
Other (divorced, widowed, separated, no response)
|
86 participants
n=5 Participants
|
63 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Annual Income
Less than $20,000
|
60 participants
n=5 Participants
|
57 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Annual Income
Over $20,000
|
43 participants
n=5 Participants
|
41 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Annual Income
Don't Know/Refused
|
42 participants
n=5 Participants
|
49 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
History of Mood Disorders
Yes
|
65 participants
n=5 Participants
|
67 participants
n=7 Participants
|
132 participants
n=5 Participants
|
|
History of Mood Disorders
No
|
80 participants
n=5 Participants
|
78 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
History of Mood Disorders
Don't Know/Refused
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Taking antidepressant meds at baseline
Yes
|
71 participants
n=5 Participants
|
67 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Taking antidepressant meds at baseline
No
|
71 participants
n=5 Participants
|
79 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
Taking antidepressant meds at baseline
Don't Know/Refused
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: intent to treat
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.
Outcome measures
| Measure |
Arm 1: Depression Collaborative Care
n=114 Participants
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.
|
Arm 2: Usual Care
n=128 Participants
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.
|
|---|---|---|
|
Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment
|
11 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsDepression 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.
Outcome measures
| Measure |
Arm 1: Depression Collaborative Care
n=114 Participants
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.
|
Arm 2: Usual Care
n=128 Participants
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.
|
|---|---|---|
|
Depression Care: Treatment Response
|
36 participants
|
19 participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsDepression 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.
Outcome measures
| Measure |
Arm 1: Depression Collaborative Care
n=114 Participants
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.
|
Arm 2: Usual Care
n=128 Participants
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.
|
|---|---|---|
|
Depression Care: Depression Remission
|
22 participants
|
9 participants
|
PRIMARY outcome
Timeframe: From Baseline to 12 monthsThe 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.
Outcome measures
| Measure |
Arm 1: Depression Collaborative Care
n=114 Participants
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.
|
Arm 2: Usual Care
n=128 Participants
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.
|
|---|---|---|
|
Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months
|
118.74 Depression Free Days (DFDs)
Standard Deviation 106.68
|
109.30 Depression Free Days (DFDs)
Standard Deviation 117.88
|
SECONDARY outcome
Timeframe: 12 monthsQuality 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.
Outcome measures
| Measure |
Arm 1: Depression Collaborative Care
n=114 Participants
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.
|
Arm 2: Usual Care
n=128 Participants
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.
|
|---|---|---|
|
Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received
|
.89 proportion of QIs met
Standard Deviation .16
|
.83 proportion of QIs met
Standard Deviation .19
|
SECONDARY outcome
Timeframe: 12 monthsMedication 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.
Outcome measures
| Measure |
Arm 1: Depression Collaborative Care
n=114 Participants
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.
|
Arm 2: Usual Care
n=128 Participants
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.
|
|---|---|---|
|
Medication Adherence: Medication Possession Ratio
|
.83 medication posession ratio
Standard Deviation .20
|
.78 medication posession ratio
Standard Deviation .24
|
Adverse Events
Arm 1: Depression Collaborative Care
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Usual Care
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Depression Collaborative Care
n=145 participants at risk
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.
|
Arm 2: Usual Care
n=147 participants at risk
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.
|
|---|---|---|
|
General disorders
Death (IRB determined unrelated to the study)
|
4.1%
6/145 • Number of events 6 • 12 months
|
2.0%
3/147 • Number of events 3 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Fasiha Kanwal, MD, MSHS
Michael E. DeBakey VA Medical Center
Phone: (713) 440-4495
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place