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Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs) (Seva)

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ClinicalTrials.gov Identifier: NCT01963234
Recruitment Status : Completed
First Posted : October 16, 2013
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Dartmouth College
Center for Health Enhancement System Studies
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Substance Use Disorders
HIV
Intervention: Behavioral: Seva

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Seva - Patients Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.
Seva - Clinicians We will analyze data of clinicians who use Seva (e.g. clinical adoption).

Participant Flow:   Overall Study
    Seva - Patients   Seva - Clinicians
STARTED   268   171 
COMPLETED   207   171 
NOT COMPLETED   61   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Seva - Madison Site Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.
Seva - Missoula Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.
Seva - Bronx Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.
Total Total of all reporting groups

Baseline Measures
   Seva - Madison Site   Seva - Missoula   Seva - Bronx   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   100   71   268 
Age 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      97 100.0%      100 100.0%      71 100.0%      268 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
Female      52  53.6%      40  40.0%      35  49.3%      127  47.4% 
Male      45  46.4%      60  60.0%      36  50.7%      141  52.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
Hispanic or Latino      1   1.0%      2   2.0%      35  49.3%      38  14.2% 
Not Hispanic or Latino      96  99.0%      98  98.0%      36  50.7%      230  85.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
American Indian or Alaska Native      4   4.1%      8   8.0%      1   1.4%      13   4.9% 
Asian      0   0.0%      1   1.0%      0   0.0%      1   0.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      30  30.9%      2   2.0%      35  49.3%      67  25.0% 
White      63  64.9%      89  89.0%      24  33.8%      176  65.7% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      11  15.5%      11   4.1% 
Region of Enrollment 
[Units: Participants]
       
United States         
Participants Analyzed   97   100   71   268 
United States   97   100   71   268 
Insured by medicare 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   8   12   8   28 
Insured by medicaid 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   55   23   33   111 
Insured by private/other 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   18   19   20   57 
Not insured 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   16   46   10   72 
Patient-centered medical home (PCMH) designation [1] [2] 
[Units: Level]
       
Participants Analyzed   97   100   71   268 
   3   3   3   NA [2] 
[1] Three levels of recognition exist, based on practice sites meeting six standards. Level three clinics have the best adherence to the standards. Those standards include team-based care and practice organization, knowing and managing patients, patient-centered access and continuity, care management and support, care coordination and care transitions, and performance measurement and quality improvement.
[2] Site specific.
Patients enrolled in Seva 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   97   100   71   268 
Any drinking days [1] [2] [3] 
[Units: Days]
Mean (Standard Deviation)
       
Participants Analyzed   72   74   61   207 
   NA [3]   NA [3]   NA [3]   2.53  (6.01) 
[1] within the last 30 days.
[2] Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Risky drinking days [1] [2] [3] 
[Units: Days]
Mean (Standard Deviation)
       
Participants Analyzed   72   74   61   207 
   NA [3]   NA [3]   NA [3]   1.25  (3.78) 
[1] within the last 30 days.
[2] Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Illicit drug-use days [1] [2] [3] 
[Units: Days]
Mean (Standard Deviation)
       
Participants Analyzed   72   74   60   206 
   NA [3]   NA [3]   NA [3]   3.22  (7.57) 
[1] within the last 30 days.
[2] Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Overall quality of life (QoL) [1] [2] [3] 
[Units: Score on a scale]
Mean (Standard Deviation)
       
Participants Analyzed   71   72   59   202 
   NA [3]   NA [3]   NA [3]   28.47  (6.46) 
[1] Higher scores on the scale indicate higher quality of life. Scale ranges from 8 to 40. It includes mental and physical health sub scale values. These values are summed
[2] Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Physical subscale Quality of Life [1] [2] [3] 
[Units: Score on a scale]
Mean (Standard Deviation)
       
Participants Analyzed   72   74   60   206 
   NA [3]   NA [3]   NA [3]   13.2  (3.01) 
[1] Higher scores on the scale indicate higher quality of life. It includes 4 items on overall physical health, physical function, pain, and fatigue that each has a scale ranging from 1 to 5. These values are summed. Scale ranges from 4 to 20.
[2] Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Mental subscale Quality of Life [1] [2] [3] 
[Units: Score on a scale]
Mean (Standard Deviation)
       
Participants Analyzed   71   73   60   204 
   NA [3]   NA [3]   NA [3]   9.75  (2.99) 
[1] Higher scores on the scale indicate higher quality of life. There are 4 questions that have scales that range from values of 1 to 5. These values are summed to give the score for the mental subscale quality of life. Scale ranges from 4 to 20.
[2] Participants dropped out of the study over the duration.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Number of hospitalizations [1] [2] [3] 
[Units: Hospitalizations]
Mean (Standard Deviation)
       
Participants Analyzed   72   74   61   207 
   NA [3]   NA [3]   NA [3]   0.43  (1.03) 
[1] Within the last 6 months.
[2] Participants dropped out of the study over the duration.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Number of ER visits [1] [2] [3] 
[Units: ER visits]
Mean (Standard Deviation)
       
Participants Analyzed   72   74   61   207 
   NA [3]   NA [3]   NA [3]   1.10  (2.79) 
[1] within the past 6 months.
[2] Participants dropped out over the duration of the study.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Any drink [1] [2] [3] 
[Units: Participants]
       
Participants Analyzed   72   74   61   207 
   NA [3]   NA [3]   NA [3]   64 
[1] within the last 30 days.
[2] Participants dropped out over the duration of the study.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Illicit drug use [1] [2] [3] 
[Units: Participants]
       
Participants Analyzed   72   74   60   206 
   NA [3]   NA [3]   NA [3]   63 
[1] within the last 30 days.
[2] Participants dropped out of the study over time.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Any drink or drug [1] [2] [3] 
[Units: Participants]
       
Participants Analyzed   72   74   60   206 
   NA [3]   NA [3]   NA [3]   97 
[1] within the last 30 days.
[2] Participants dropped out of the study over time.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Currently receive other addiction treatment [1] [2] [3] 
[Units: Participants]
       
Participants Analyzed   72   74   61   207 
   NA [3]   NA [3]   NA [3]   89 
[1] within the last 6 months.
[2] Participants dropped out over time.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
HIV risky behavior [1] [2] [3] 
[Units: Participants]
       
Participants Analyzed   72   74   61   207 
   NA [3]   NA [3]   NA [3]   76 
[1] within the last 6 months.
[2] Participants dropped out over time.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
HIV testing [1] [2] [3] 
[Units: Participants]
       
Participants Analyzed   72   74   60   206 
   NA [3]   NA [3]   NA [3]   81 
[1] within the past 6 months.
[2] Participants dropped out over time.
[3] Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.
Drug of choice is alcohol 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   34   44   27   105 
Drug of choice is Opiates 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   31   14   8   53 
Drug of choice is crack cocaine 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   9   3   11   23 
Drug of choice is marijuana 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   1   4   16   21 
Drug of choice is methamphetamine 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   0   15   1   16 
Drug of choice is multiple drugs 
[Units: Participants]
Count of Participants
       
Participants Analyzed   97   100   71   268 
   22   20   8   50 


  Outcome Measures

1.  Primary:   Implementation Status   [ Time Frame: up to 3 years ]

2.  Primary:   Any Drinking Days in Last 30 Days   [ Time Frame: 6 months ]

3.  Primary:   Risky Drinking Days in the Last 30 Days   [ Time Frame: 6 months ]

4.  Primary:   Illicit Drug-use Within the Last 30 Days   [ Time Frame: 6 months ]

5.  Primary:   Overall Quality of Life   [ Time Frame: 6 months ]

6.  Primary:   Physical Subscale Quality of Life   [ Time Frame: 6 months ]

7.  Primary:   Mental Subscale Quality of Life   [ Time Frame: 6 months ]

8.  Primary:   Patient Had Any Drink Within the Last 30 Days   [ Time Frame: 6 months ]

9.  Primary:   Patient Had Illicit Drug Use Within the Last 30 Days   [ Time Frame: 6 months ]

10.  Primary:   Patient Had Any Drink or Drug Use Within the Last 30 Days   [ Time Frame: 6 months ]

11.  Primary:   Patients, Within the Last 6 Months Have Received Other Addiction Treatment   [ Time Frame: 6 months ]

12.  Primary:   Patients Partook in HIV Risky Behavior in the Last 6 Months   [ Time Frame: 6 months ]

13.  Primary:   Patients Partook in HIV Testing in the Last 6 Months   [ Time Frame: 6 months ]

14.  Secondary:   Number of Patients Using System   [ Time Frame: up to 3 years ]

15.  Secondary:   Clinical Adoption   [ Time Frame: up to 3 years ]

16.  Secondary:   Total Costs for Clinic   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew Quanbeck
Organization: University of Wisconsin - Madison
phone: 6082627385
e-mail: arquanbe@wisc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01963234     History of Changes
Other Study ID Numbers: 2012-0937
R01DA034279-01 ( U.S. NIH Grant/Contract )
First Submitted: October 9, 2013
First Posted: October 16, 2013
Results First Submitted: February 28, 2018
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018