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An Integrated Care Model for Improving Hepatitis C Virus Patient Outcomes (HCV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722423
First Posted: July 25, 2008
Last Update Posted: October 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: March 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Hepatitis C
Interventions: Behavioral: Integrated care model
Behavioral: Usual Care Model

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Integrated Care Model   Usual Care Model
STARTED   182   182 
COMPLETED   182   181 
NOT COMPLETED   0   1 
Protocol Violation                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Integrated Care Model 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 No text entered.
Total Total of all reporting groups

Baseline Measures
   Integrated Care Model   Usucal Care Model   Total 
Overall Participants Analyzed 
[Units: Participants]
 182   181   363 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   182   181   363 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.3  (5.51)   55.5  (5.79)   55.4  (5.65) 
Gender 
[Units: Participants]
     
Female   4   4   8 
Male   178   177   355 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   32   33   65 
Not Hispanic or Latino   69   62   131 
Unknown or Not Reported   81   86   167 
Region of Enrollment 
[Units: Participants]
     
United States   182   181   363 


  Outcome Measures
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1.  Primary:   Sustained Virologic Response Rates   [ Time Frame: 12-24 weeks post-treatment ]

2.  Secondary:   Antiviral Treatment Rate   [ Time Frame: 12-24 weeks post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Samuel B. Ho
Organization: VA San Diego Healthcare System
phone: 8586423280
e-mail: Samuel.Ho2@va.gov


Publications of Results:
Other Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00722423     History of Changes
Other Study ID Numbers: IIR 07-101
First Submitted: July 23, 2008
First Posted: July 25, 2008
Results First Submitted: March 24, 2015
Results First Posted: October 15, 2015
Last Update Posted: October 15, 2015