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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
Enrollment 439
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Seva - Patients Seva - Clinicians
Hide Arm/Group Description Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders. We will analyze data of clinicians who use Seva (e.g. clinical adoption).
Period Title: Overall Study
Started 268 171
Completed 207 171
Not Completed 61 0
Arm/Group Title Seva - Madison Site Seva - Missoula Seva - Bronx Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 97 100 71 268
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
<=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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants 100 participants 71 participants 268 participants
97 100 71 268
Insured by medicare  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
8
   8.2%
12
  12.0%
8
  11.3%
28
  10.4%
Insured by medicaid  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
55
  56.7%
23
  23.0%
33
  46.5%
111
  41.4%
Insured by private/other  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
18
  18.6%
19
  19.0%
20
  28.2%
57
  21.3%
Not insured  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
16
  16.5%
46
  46.0%
10
  14.1%
72
  26.9%
Patient-centered medical home (PCMH) designation   [1] 
Measure Type: Number
Unit of measure:  Level
Number Analyzed 97 participants 100 participants 71 participants 268 participants
3 3 3 NA [2] 
[1]
Measure Description: 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
97
 100.0%
100
 100.0%
71
 100.0%
268
 100.0%
Any drinking days   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 72 participants 74 participants 61 participants 207 participants
NA [3]   (NA) NA [3]   (NA) NA [3]   (NA) 2.53  (6.01)
[1]
Measure Description: within the last 30 days.
[2]
Measure Analysis Population Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 72 participants 74 participants 61 participants 207 participants
NA [3]   (NA) NA [3]   (NA) NA [3]   (NA) 1.25  (3.78)
[1]
Measure Description: within the last 30 days.
[2]
Measure Analysis Population Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 72 participants 74 participants 60 participants 206 participants
NA [3]   (NA) NA [3]   (NA) NA [3]   (NA) 3.22  (7.57)
[1]
Measure Description: within the last 30 days.
[2]
Measure Analysis Population Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 71 participants 72 participants 59 participants 202 participants
NA [3]   (NA) NA [3]   (NA) NA [3]   (NA) 28.47  (6.46)
[1]
Measure Description: 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]
Measure Analysis Population Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 72 participants 74 participants 60 participants 206 participants
NA [3]   (NA) NA [3]   (NA) NA [3]   (NA) 13.2  (3.01)
[1]
Measure Description: 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]
Measure Analysis Population Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 71 participants 73 participants 60 participants 204 participants
NA [3]   (NA) NA [3]   (NA) NA [3]   (NA) 9.75  (2.99)
[1]
Measure Description: 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]
Measure Analysis Population Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Hospitalizations
Number Analyzed 72 participants 74 participants 61 participants 207 participants
NA [3]   (NA) NA [3]   (NA) NA [3]   (NA) 0.43  (1.03)
[1]
Measure Description: Within the last 6 months.
[2]
Measure Analysis Population Description: 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] 
Mean (Standard Deviation)
Unit of measure:  ER visits
Number Analyzed 72 participants 74 participants 61 participants 207 participants
NA [3]   (NA) NA [3]   (NA) NA [3]   (NA) 1.10  (2.79)
[1]
Measure Description: within the past 6 months.
[2]
Measure Analysis Population Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 61 participants 207 participants
NA [3]  NA [3]  NA [3]  64
[1]
Measure Description: within the last 30 days.
[2]
Measure Analysis Population Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 60 participants 206 participants
NA [3]  NA [3]  NA [3]  63
[1]
Measure Description: within the last 30 days.
[2]
Measure Analysis Population Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 60 participants 206 participants
NA [3]  NA [3]  NA [3]  97
[1]
Measure Description: within the last 30 days.
[2]
Measure Analysis Population Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 61 participants 207 participants
NA [3]  NA [3]  NA [3]  89
[1]
Measure Description: within the last 6 months.
[2]
Measure Analysis Population Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 61 participants 207 participants
NA [3]  NA [3]  NA [3]  76
[1]
Measure Description: within the last 6 months.
[2]
Measure Analysis Population Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 60 participants 206 participants
NA [3]  NA [3]  NA [3]  81
[1]
Measure Description: within the past 6 months.
[2]
Measure Analysis Population Description: 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
34
  35.1%
44
  44.0%
27
  38.0%
105
  39.2%
Drug of choice is Opiates  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
31
  32.0%
14
  14.0%
8
  11.3%
53
  19.8%
Drug of choice is crack cocaine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
9
   9.3%
3
   3.0%
11
  15.5%
23
   8.6%
Drug of choice is marijuana  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
1
   1.0%
4
   4.0%
16
  22.5%
21
   7.8%
Drug of choice is methamphetamine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
0
   0.0%
15
  15.0%
1
   1.4%
16
   6.0%
Drug of choice is multiple drugs  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 100 participants 71 participants 268 participants
22
  22.7%
20
  20.0%
8
  11.3%
50
  18.7%
1.Primary Outcome
Title Implementation Status
Hide Description The number of implementation milestones completed
Time Frame up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These are milestones achieved for each site.
Arm/Group Title Seva - Madison Site Seva - Missoula Seva - Bronx
Hide Arm/Group Description:
We identified 12 milestones for to meet for each site.
We identified 12 milestones for to meet for each site.
We identified 12 milestones for to meet for each site.
Overall Number of Participants Analyzed 72 74 61
Overall Number of Units Analyzed
Type of Units Analyzed: Milestones
12 12 12
Measure Type: Number
Unit of Measure: milestones
12 12 12
2.Primary Outcome
Title Any Drinking Days in Last 30 Days
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 207
Mean (Standard Deviation)
Unit of Measure: days
1.67  (4.69)
3.Primary Outcome
Title Risky Drinking Days in the Last 30 Days
Hide Description Analysis for measure was done for the total of all three sites combined.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 207
Mean (Standard Deviation)
Unit of Measure: days
0.70  (2.58)
4.Primary Outcome
Title Illicit Drug-use Within the Last 30 Days
Hide Description Analysis for measure was done for the total of all three sites combined.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 206
Mean (Standard Deviation)
Unit of Measure: days
2.14  (6.55)
5.Primary Outcome
Title Overall Quality of Life
Hide Description Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. Value was calculated by adding the mental and physical subscale values. Values could range from 8 to 40.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 202
Mean (Standard Deviation)
Unit of Measure: score on a scale
30.03  (7.11)
6.Primary Outcome
Title Physical Subscale Quality of Life
Hide Description Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This scare consisted of 4 questions that had scales ranging from 1 to 5. The scores were summed and values could range from 4 to 20.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 206
Mean (Standard Deviation)
Unit of Measure: score on a scale
13.48  (3.11)
7.Primary Outcome
Title Mental Subscale Quality of Life
Hide Description Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This consisted of 4 questions that had scaled ranging from 1 to 5. The scores of the scales were summed and values could range from 4 to 20.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 204
Mean (Standard Deviation)
Unit of Measure: score on a scale
10.77  (3.50)
8.Primary Outcome
Title Patient Had Any Drink Within the Last 30 Days
Hide Description Analysis for measure was done for the total of all three sites combined.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 207
Measure Type: Count of Participants
Unit of Measure: Participants
51
  24.6%
9.Primary Outcome
Title Patient Had Illicit Drug Use Within the Last 30 Days
Hide Description Analysis for measure was done for the total of all three sites combined.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 206
Measure Type: Count of Participants
Unit of Measure: Participants
36
  17.5%
10.Primary Outcome
Title Patient Had Any Drink or Drug Use Within the Last 30 Days
Hide Description Analysis for measure was done for the total of all three sites combined.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed because data was self reported and patients were allowed to not answer questions if they chose.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 204
Measure Type: Count of Participants
Unit of Measure: Participants
69
  33.8%
11.Primary Outcome
Title Patients, Within the Last 6 Months Have Received Other Addiction Treatment
Hide Description Analysis for measure was done for the total of all three sites combined.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 207
Measure Type: Count of Participants
Unit of Measure: Participants
78
  37.7%
12.Primary Outcome
Title Patients Partook in HIV Risky Behavior in the Last 6 Months
Hide Description Analysis for measure was done for the total of all three sites combined.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 207
Measure Type: Count of Participants
Unit of Measure: Participants
65
  31.4%
13.Primary Outcome
Title Patients Partook in HIV Testing in the Last 6 Months
Hide Description Analysis for measure was done for the total of all three sites combined.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed is lower because data is self reported and patients could chose not to answer some questions.
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 206
Measure Type: Count of Participants
Unit of Measure: Participants
116
  56.3%
14.Secondary Outcome
Title Number of Patients Using System
Hide Description Analysis for measure was done for the total of all three sites combined.
Time Frame up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seva
Hide Arm/Group Description:
Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed 268
Measure Type: Count of Participants
Unit of Measure: Participants
268
 100.0%
15.Secondary Outcome
Title Clinical Adoption
Hide Description We analyzed computerized system log files to produce patterns of system adoption of the staff.
Time Frame up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This is the number of primary care clinical staff at the 3 sites who adopted using Seva.
Arm/Group Title Seva - Clinicians
Hide Arm/Group Description:
This is the number of clinicians who work within clinics where Seva was implemented.
Overall Number of Participants Analyzed 171
Measure Type: Count of Participants
Unit of Measure: Participants
171
 100.0%
16.Secondary Outcome
Title Total Costs for Clinic
Hide Description This includes the clinic operating costs and clinic implementation costs of the intervention.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was analyzed at the clinic level. Thus, NA is indicated for "Overall number of participants analyzed."
Arm/Group Title Seva - Madison Site Seva - Missoula Seva - Bronx
Hide Arm/Group Description:
Patients will receive access to the Seva mobile health system for drug use disorders.
Patients will receive access to the Seva mobile health system for drug use disorders.
Patients will receive access to the Seva mobile health system for drug use disorders.
Overall Number of Participants Analyzed NA NA NA
Overall Number of Units Analyzed
Type of Units Analyzed: Clinic
1 1 1
Measure Type: Number
Unit of Measure: US dollars
123584 140495 111298
Time Frame Up to 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Seva - Patients Seva - Clinicians
Hide Arm/Group Description Patients will receive access to the Seva mobile health system for drug use disorders. Clinicians who worked at Seva sites were also monitored for Adverse events.
All-Cause Mortality
Seva - Patients Seva - Clinicians
Affected / at Risk (%) Affected / at Risk (%)
Total   3/268 (1.12%)      0/171 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Seva - Patients Seva - Clinicians
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/268 (1.12%)      0/171 (0.00%)    
General disorders     
Death  [1]  2/268 (0.75%)  2 0/171 (0.00%)  0
Death  [2]  1/268 (0.37%)  1 0/171 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
These deaths were non-study related.
[2]
This was a non-study related death. This participant died of Chronic Obstructive Pulmonary Disease and emphysema.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Seva - Patients Seva - Clinicians
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/268 (0.00%)      0/171 (0.00%)    
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
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