Trial Outcomes & Findings for Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment (NCT NCT02648022)
NCT ID: NCT02648022
Last Updated: 2016-05-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
up to 24 weeks
Results posted on
2016-05-20
Participant Flow
83 patients were consented but only 79 were randomized. 4 participants were withdrawn.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
|
Overall Study
COMPLETED
|
40
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
Baseline characteristics by cohort
| Measure |
Integrated Care
n=40 Participants
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.
|
Usual Care
n=39 Participants
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
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
57.4 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
55.7 years
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Gender
Female
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Gender
Male
|
37 participants
n=99 Participants
|
38 participants
n=107 Participants
|
75 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
7 participants
n=99 Participants
|
12 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=99 Participants
|
22 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
39 participants
n=107 Participants
|
79 participants
n=206 Participants
|
|
Marital Status
Single
|
11 participants
n=99 Participants
|
9 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Marital Status
Married or widowed
|
11 participants
n=99 Participants
|
14 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Marital Status
Separated or Divorced
|
18 participants
n=99 Participants
|
15 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Marital Status
Missing
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Education
Grade 1 to 8
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Education
Grade 9 to 11
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Education
High school/GED
|
12 participants
n=99 Participants
|
6 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Education
Some College
|
21 participants
n=99 Participants
|
22 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Education
College Grad
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Education
Post Grad
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Education
Missing
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Employment
Full and Part time
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Employment
Unemployed
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Employment
Disabled
|
15 participants
n=99 Participants
|
14 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Employment
Retired or Volunteer
|
7 participants
n=99 Participants
|
4 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Employment
Missing
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Homeless in last 5 years
Homeless in the last 5 years
|
18 participants
n=99 Participants
|
20 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Homeless in last 5 years
Missing
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Homeless in last 5 years
Not Homeless
|
19 participants
n=99 Participants
|
14 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
BMI
|
29.0 Kilograms/m2
STANDARD_DEVIATION 5.8 • n=99 Participants
|
28.6 Kilograms/m2
STANDARD_DEVIATION 5.3 • n=107 Participants
|
28.8 Kilograms/m2
STANDARD_DEVIATION 5.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksThe 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.
Outcome measures
| Measure |
Integrated Care
n=40 Participants
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.
|
Usual Care
n=39 Participants
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
|
|---|---|---|
|
Sustained Viral Response (SVR)
|
30 percentage of Participants
|
12.8 percentage of Participants
|
SECONDARY outcome
Timeframe: up to 24 weeksThe 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.
Outcome measures
| Measure |
Integrated Care
n=40 Participants
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.
|
Usual Care
n=39 Participants
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
|
|---|---|---|
|
Percentage of Participants With Treatment Initiation and Completion
|
45 percentage of Particpants
|
23.1 percentage of Particpants
|
SECONDARY outcome
Timeframe: up to 24 weeksPatients 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.
Outcome measures
| Measure |
Integrated Care
n=40 Participants
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.
|
Usual Care
n=39 Participants
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
|
|---|---|---|
|
Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
|
78 percentage of participants
|
63 percentage of participants
|
Adverse Events
Integrated Care
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Integrated Care
n=40 participants at risk
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.
|
Usual Care
n=39 participants at risk
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
|
|---|---|---|
|
General disorders
Hospitalization
|
20.0%
8/40
|
15.4%
6/39
|
|
General disorders
Death
|
0.00%
0/40
|
2.6%
1/39
|
|
Cardiac disorders
Death
|
0.00%
0/40
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.00%
0/40
|
2.6%
1/39
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place