Trial Outcomes & Findings for An Integrated Care Model for Improving Hepatitis C Virus Patient Outcomes (NCT NCT00722423)

NCT ID: NCT00722423

Last Updated: 2015-10-15

Results Overview

Virus not detected by PCR assay

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 364 participants
• Primary outcome timeframe: 12-24 weeks post-treatment
• Results posted on: 2015-10-15

Participant Flow

Participant milestones

Measure	Integrated Care Model Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.	Usual Care Model Patients randomized to usual care (UC) received "standard of care" required for HCV patients consistent with current VA treatment guidelines and clinic structures.
Overall Study STARTED	182	182
Overall Study COMPLETED	182	181
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Integrated Care Model Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.	Usual Care Model Patients randomized to usual care (UC) received "standard of care" required for HCV patients consistent with current VA treatment guidelines and clinic structures.
Overall Study Protocol Violation	0	1

Baseline Characteristics

An Integrated Care Model for Improving Hepatitis C Virus Patient Outcomes

Baseline characteristics by cohort

Measure	Integrated Care Model n=182 Participants Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.	Usucal Care Model n=181 Participants	Total n=363 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	182 Participants n=5 Participants	181 Participants n=7 Participants	363 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	55.3 years STANDARD_DEVIATION 5.51 • n=5 Participants	55.5 years STANDARD_DEVIATION 5.79 • n=7 Participants	55.4 years STANDARD_DEVIATION 5.65 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	178 Participants n=5 Participants	177 Participants n=7 Participants	355 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants	62 Participants n=7 Participants	131 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	81 Participants n=5 Participants	86 Participants n=7 Participants	167 Participants n=5 Participants
Region of Enrollment United States	182 participants n=5 Participants	181 participants n=7 Participants	363 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-24 weeks post-treatment

Virus not detected by PCR assay

Outcome measures

Measure	Integrated Care Model n=182 Participants integrated care Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.	Usual Care Model n=181 Participants usual care Patients receive care as usual in their HCV clinic. This care does not include the co-located mental health provider.
Sustained Virologic Response Rates	29 participants	14 participants

SECONDARY outcome

Timeframe: 12-24 weeks post-treatment

Number of patients started antiviral treatment

Outcome measures

Measure	Integrated Care Model n=182 Participants integrated care Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.	Usual Care Model n=181 Participants usual care Patients receive care as usual in their HCV clinic. This care does not include the co-located mental health provider.
Antiviral Treatment Rate	31.9 percentage of participants	18.8 percentage of participants

Adverse Events

Integrated Care Model

Serious events: 112 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Model

Serious events: 125 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Integrated Care Model n=182 participants at risk Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.	Usual Care Model n=181 participants at risk Patients randomized to usual care (UC) received "standard of care" required for HCV patients consistent with current VA treatment guidelines and clinic structures.
General disorders Hospitalization Events	57.1% 104/182 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.	61.9% 112/181 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.
Cardiac disorders Cardiac Arrest	0.55% 1/182 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.	1.1% 2/181 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.55% 1/182 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.	1.1% 2/181 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.
General disorders Medication Overdose	0.55% 1/182 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.	0.00% 0/181 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.
Gastrointestinal disorders Decompensated Cirrhosis	1.1% 2/182 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.	1.1% 2/181 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.
General disorders Death	1.6% 3/182 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.	4.4% 8/181 Other not serious adverse events were not collected. Only serious adverse events were collected. Specific adverse events were not known for the hospitalization event.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Samuel B. Ho

VA San Diego Healthcare System

Phone: 8586423280

Email: Samuel.Ho2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place