Trial Outcomes & Findings for Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment (NCT 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

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83 patients were consented but only 79 were randomized. 4 participants were withdrawn.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

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

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=5 Participants	57.4 years STANDARD_DEVIATION 7.7 • n=7 Participants	55.7 years STANDARD_DEVIATION 8.4 • n=5 Participants
Gender Female	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Gender Male	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants
Race/Ethnicity, Customized African American or Black	7 participants n=5 Participants	12 participants n=7 Participants	19 participants n=5 Participants
Race/Ethnicity, Customized Native American	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	25 participants n=5 Participants	22 participants n=7 Participants	47 participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	39 participants n=7 Participants	79 participants n=5 Participants
Marital Status Single	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Marital Status Married or widowed	11 participants n=5 Participants	14 participants n=7 Participants	25 participants n=5 Participants
Marital Status Separated or Divorced	18 participants n=5 Participants	15 participants n=7 Participants	33 participants n=5 Participants
Marital Status Missing	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Education Grade 1 to 8	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Education Grade 9 to 11	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Education High school/GED	12 participants n=5 Participants	6 participants n=7 Participants	18 participants n=5 Participants
Education Some College	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants
Education College Grad	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Education Post Grad	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Education Missing	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Employment Full and Part time	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Employment Unemployed	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants
Employment Disabled	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants
Employment Retired or Volunteer	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Employment Missing	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Homeless in last 5 years Homeless in the last 5 years	18 participants n=5 Participants	20 participants n=7 Participants	38 participants n=5 Participants
Homeless in last 5 years Missing	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Homeless in last 5 years Not Homeless	19 participants n=5 Participants	14 participants n=7 Participants	33 participants n=5 Participants
BMI	29.0 Kilograms/m2 STANDARD_DEVIATION 5.8 • n=5 Participants	28.6 Kilograms/m2 STANDARD_DEVIATION 5.3 • n=7 Participants	28.8 Kilograms/m2 STANDARD_DEVIATION 5.5 • n=5 Participants

PRIMARY outcome

Timeframe: up to 24 weeks

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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

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

Dr. Samuel B. Ho

Va San Diego Healthcare System

Phone: 858-552-8585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place