Depression is highly prevalent, yet under-diagnosed and under-treated in patients with chronic hepatitis C virus infection (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 treatment in VA primary care settings. However, there is little evidence supporting 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. Building on the HIV clinic experience, the current study, "Hepatitis-Translating Initiatives for Depression into Effective Solutions (HEP-TIDES)" adapted and tested this intervention for CHC patients.
1) Adapt and adopt the collaborative care model for improving depression care in specialty CHC care settings,
(2) Compare CHC outcomes for HEP-TIDES versus usual care, and
(3) Compare depression outcomes for HEP-TIDES versus usual care
HEP-TIDES is a multi-site, multi-method implementation project. HEP-TIDES used 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 VA facilities. HEP-TIDES involved CHC and mental health providers working with an off-site depression care team comprised of a nurse depression care manager, pharmacist, and psychiatrist. The purpose of the team was to support CHC and mental health clinicians in delivering evidence-based stepped-care depression treatment. The adapted model also addressed the substance use disorders among CHC patients. The HEP-TIDES intervention was assessed using a formative evaluation of the implementation process and a summative evaluation of a randomized controlled implementation trial of collaborative depression care.
Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline, 6-, and 12-months. Depression treatment response was defined as a 50% or greater decrease in the mean SCL-20 score compared with baseline and remission was defined as an item mean SCL-20 score of less than 0.5. 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.
Objective 1: The pre-implementation evaluation included semi-structured interviews and surveys from 17 providers (10 CHC providers and 7 mental health providers) and 9 CHC patients and observations of stakeholder evidence-based quality improvement (EBQI) meetings. According to the survey results, CHC providers were typically not comfortable with diagnosing, treating, or managing depression for their CHC patients, nor were they comfortable with using a standardized depression severity screener, adjusting anti-depressant medications, or referring to a mental health specialist. However, they were typically comfortable discussing depression with their patients.
The most commonly noted pre-implementation barrier to identifying depression was the lack of a structure, process, and/or protocol. Other pre-implementation factors included: relationship between CHC and mental health clinics, leadership involvement, provider buy-in, and local champions. Patients expressed a sense of stigma around both their CHC and depression diagnoses and the desire to keep their CHC diagnosis hidden from others which inhibited treatment-seeking, especially for depression. CHC and MH providers also observed this lack of willingness among CHC patients to pursue depression treatment, particularly antidepressant medications for patients in substance use disorder recovery.
Objective 2: We recruited a total of 309 patients from CHC clinics with confirmed CHC infection positive screen (score of 10 or higher) for major depression using the 9-item Patient Health Questionnaire (PHQ-9). 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.
The majority of participants were men and mean age was 59 years. Approximately half of our sample was African American and 35% were married. The annual income was lower than $20,000 in 40% of the patients. Most had a history of mood disorder and approximately 50% were already prescribed an antidepressant medication at the time of enrollment. 41% of patients preferred not to take an antidepressant as a treatment for depression. Half of the sample had comorbid generalized anxiety disorder and most had at-least one drink of alcohol in the preceding year.
All intervention patients were contacted by the depression care manager (DCM). Initial patient education, activation, and treatment barriers assessment was completed for 99% of intervention patients. During the acute phase of treatment, a total of 255 intervention group treatment trials were conducted including 99 (38.8%) watchful waiting, 86 (33.7%) pharmacotherapy, 15 (5.9%) counseling, and 55 (21.6%) combination pharmacotherapy and counseling trials. The mean number of DCM intervention telephone contacts per patient during the acute and continuation phases of treatment was 8.61 (1,266/147, range=0-16).
A relatively small number of patients (18 total: 7 control and 11 intervention) initiated CHC antiviral treatment during study period. Nine patients (5 control and 4 intervention) initiated during the first 6 months of enrollment and 8 patients (2 control and 6 intervention) completed antiviral treatment. Patients and CHC providers reported that they were postponing treatment until the newer direct acting antiviral (DAA) medications were approved which occurred towards the end of study enrollment.
Aim 3: In unadjusted 6-month analyses, intervention participants trended (p>0.05) toward more treatment response (18.7% vs. 11.4%), remission (12.2% vs. 6.5%), and depression-free days (DFDs 45.5 vs. 39.1) than usual care participants. After adjusting for comorbid mental health conditions and liver disease severity at baseline, these trends reached statistical significance for all three primary endpoints: response (OR=2.35, 95%CI=1.07-5.13), remission (OR=3.20, 95%CI=1.06-9.64) and DFDs (beta=9.5 days, 95%CI=1.2-17.7).
In unadjusted 12-month analyses, intervention participants reported more treatment response (31.6% vs. 14.8%, p=0.002), remission (19.3% vs. 7.0%, p=0.004), and DFDs controlling for baseline depression severity (beta=24.46, 95%CI=3.48-45.45) than usual care participants. In 12-month adjusted analyses, the intervention was statistically significant for all three primary endpoints: response (OR=3.44, 95%CI=1.74-6.79), remission (OR=3.83, 95%CI=2.02-7.25) and DFDs (beta=29.3 days, 95%CI=9.4-49.2).
Intervention depression outcomes improved over time which is not consistent with the typical pattern of depression outcomes being significantly improved at 6-months but not 12-months. Effective depression interventions will continue to be needed in the era of DAA medication treatments for CHC.
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