Depression, Fibrosis, Hepatitis C, PTSD, Substance Use Disorder
Conditions
Keywords
Care Integration, Hepatitis C, Substance Use Disorder, PTSD
Brief summary
To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.
Detailed description
Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a new era of more effective treatments for hepatitis C (HCV). The impact of more effective therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (SUD). Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and provided brief mental health care and case management.
Interventions
BEHAVIORALBrief mental health interventions and case management
The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic * All patients 18 and 75 years old with confirmed HCV infection * Patients were required to be classified as high risk candidates for antiviral treatment on any one of a set of screening measure in order to participate * Screening measures and cutoffs for inclusion were depression: * Beck Depression Inventory: (BDI) \> 10 * Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) \> 4 * PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any single endorsement of item #3 * Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6 months prior to screen
Exclusion criteria
* Lacked a confirmed test of HCV RNA * Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic) * Had Hepatitis B (HBV) co-infection * Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C * Had other significant near term life-threatening diseases * Were treatment non-responders with pegylated Interferon plus ribavirin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Viral Response (SVR) | up to 24 weeks | The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Initiation and Completion | up to 24 weeks | The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment. |
| Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80% | up to 24 weeks | Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment. |
Countries
United States
Participant flow
Pre-assignment details
83 patients were consented but only 79 were randomized. 4 participants were withdrawn.
Participants by arm
| Arm | Count |
|---|---|
| Integrated Care Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians. | 40 |
| Usual Care The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist | 39 |
| Total | 79 |
Baseline characteristics
| Characteristic | Integrated Care | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 8.7 | 57.4 years STANDARD_DEVIATION 7.7 | 55.7 years STANDARD_DEVIATION 8.4 |
| BMI | 29.0 Kilograms/m2 STANDARD_DEVIATION 5.8 | 28.6 Kilograms/m2 STANDARD_DEVIATION 5.3 | 28.8 Kilograms/m2 STANDARD_DEVIATION 5.5 |
| Education College Grad | 2 participants | 4 participants | 6 participants |
| Education Grade 1 to 8 | 0 participants | 1 participants | 1 participants |
| Education Grade 9 to 11 | 2 participants | 2 participants | 4 participants |
| Education High school/GED | 12 participants | 6 participants | 18 participants |
| Education Missing | 3 participants | 3 participants | 6 participants |
| Education Post Grad | 0 participants | 1 participants | 1 participants |
| Education Some College | 21 participants | 22 participants | 43 participants |
| Employment Disabled | 15 participants | 14 participants | 29 participants |
| Employment Full and Part time | 4 participants | 5 participants | 9 participants |
| Employment Missing | 1 participants | 1 participants | 2 participants |
| Employment Retired or Volunteer | 7 participants | 4 participants | 11 participants |
| Employment Unemployed | 13 participants | 15 participants | 28 participants |
| Gender Female | 0 participants | 0 participants | 0 participants |
| Gender Male | 37 participants | 38 participants | 75 participants |
| Homeless in last 5 years Homeless in the last 5 years | 18 participants | 20 participants | 38 participants |
| Homeless in last 5 years Missing | 3 participants | 5 participants | 8 participants |
| Homeless in last 5 years Not Homeless | 19 participants | 14 participants | 33 participants |
| Marital Status Married or widowed | 11 participants | 14 participants | 25 participants |
| Marital Status Missing | 0 participants | 1 participants | 1 participants |
| Marital Status Separated or Divorced | 18 participants | 15 participants | 33 participants |
| Marital Status Single | 11 participants | 9 participants | 20 participants |
| Race/Ethnicity, Customized African American or Black | 7 participants | 12 participants | 19 participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic | 7 participants | 4 participants | 11 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 25 participants | 22 participants | 47 participants |
| Region of Enrollment United States | 40 participants | 39 participants | 79 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 39 |
| serious Total, serious adverse events | 8 / 40 | 6 / 39 |
Outcome results
Primary
Sustained Viral Response (SVR)
The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.
Time frame: up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Integrated Care | Sustained Viral Response (SVR) | 30 percentage of Participants |
| Usual Care | Sustained Viral Response (SVR) | 12.8 percentage of Participants |
p-value: 0.0795% CI: [0.92, 9.27]Regression, Linear
Secondary
Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
Time frame: up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Integrated Care | Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80% | 78 percentage of participants |
| Usual Care | Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80% | 63 percentage of participants |
Secondary
Percentage of Participants With Treatment Initiation and Completion
The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
Time frame: up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Integrated Care | Percentage of Participants With Treatment Initiation and Completion | 45 percentage of Particpants |
| Usual Care | Percentage of Participants With Treatment Initiation and Completion | 23.1 percentage of Particpants |