Trial Outcomes & Findings for Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs) (NCT NCT01963234)
NCT ID: NCT01963234
Last Updated: 2018-07-31
Results Overview
The number of implementation milestones completed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
439 participants
Primary outcome timeframe
up to 3 years
Results posted on
2018-07-31
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
268
|
171
|
|
Overall Study
COMPLETED
|
207
|
171
|
|
Overall Study
NOT COMPLETED
|
61
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants dropped out of the study over time.
Baseline characteristics by cohort
| Measure |
Seva - Madison Site
n=97 Participants
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
n=100 Participants
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
n=71 Participants
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
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Illicit drug use
|
NA participants
n=72 Participants • Participants dropped out of the study over time.
|
NA participants
n=74 Participants • Participants dropped out of the study over time.
|
NA participants
n=60 Participants • Participants dropped out of the study over time.
|
63 participants
n=206 Participants • Participants dropped out of the study over time.
|
|
Age, Categorical
<=18 years
|
0 Participants
n=97 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=268 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=97 Participants
|
100 Participants
n=100 Participants
|
71 Participants
n=71 Participants
|
268 Participants
n=268 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=97 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=268 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=97 Participants
|
40 Participants
n=100 Participants
|
35 Participants
n=71 Participants
|
127 Participants
n=268 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=97 Participants
|
60 Participants
n=100 Participants
|
36 Participants
n=71 Participants
|
141 Participants
n=268 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=97 Participants
|
2 Participants
n=100 Participants
|
35 Participants
n=71 Participants
|
38 Participants
n=268 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=97 Participants
|
98 Participants
n=100 Participants
|
36 Participants
n=71 Participants
|
230 Participants
n=268 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=97 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=268 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=97 Participants
|
8 Participants
n=100 Participants
|
1 Participants
n=71 Participants
|
13 Participants
n=268 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=97 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=71 Participants
|
1 Participants
n=268 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=97 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=268 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=97 Participants
|
2 Participants
n=100 Participants
|
35 Participants
n=71 Participants
|
67 Participants
n=268 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=97 Participants
|
89 Participants
n=100 Participants
|
24 Participants
n=71 Participants
|
176 Participants
n=268 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=97 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=268 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=97 Participants
|
0 Participants
n=100 Participants
|
11 Participants
n=71 Participants
|
11 Participants
n=268 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=97 Participants
|
100 participants
n=100 Participants
|
71 participants
n=71 Participants
|
268 participants
n=268 Participants
|
|
Insured by medicare
|
8 Participants
n=97 Participants
|
12 Participants
n=100 Participants
|
8 Participants
n=71 Participants
|
28 Participants
n=268 Participants
|
|
Insured by medicaid
|
55 Participants
n=97 Participants
|
23 Participants
n=100 Participants
|
33 Participants
n=71 Participants
|
111 Participants
n=268 Participants
|
|
Insured by private/other
|
18 Participants
n=97 Participants
|
19 Participants
n=100 Participants
|
20 Participants
n=71 Participants
|
57 Participants
n=268 Participants
|
|
Not insured
|
16 Participants
n=97 Participants
|
46 Participants
n=100 Participants
|
10 Participants
n=71 Participants
|
72 Participants
n=268 Participants
|
|
Patient-centered medical home (PCMH) designation
|
3 Level
n=97 Participants
|
3 Level
n=100 Participants
|
3 Level
n=71 Participants
|
NA Level
n=268 Participants
|
|
Patients enrolled in Seva
|
97 Participants
n=97 Participants
|
100 Participants
n=100 Participants
|
71 Participants
n=71 Participants
|
268 Participants
n=268 Participants
|
|
Any drinking days
|
NA days
STANDARD_DEVIATION NA • n=72 Participants • 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.
|
NA days
STANDARD_DEVIATION NA • n=74 Participants • 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.
|
NA days
STANDARD_DEVIATION NA • n=61 Participants • 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.
|
2.53 days
STANDARD_DEVIATION 6.01 • n=207 Participants • 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.
|
|
Risky drinking days
|
NA days
STANDARD_DEVIATION NA • n=72 Participants • 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.
|
NA days
STANDARD_DEVIATION NA • n=74 Participants • 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.
|
NA days
STANDARD_DEVIATION NA • n=61 Participants • 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.
|
1.25 days
STANDARD_DEVIATION 3.78 • n=207 Participants • 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.
|
|
Illicit drug-use days
|
NA days
STANDARD_DEVIATION NA • n=72 Participants • 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.
|
NA days
STANDARD_DEVIATION NA • n=74 Participants • 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.
|
NA days
STANDARD_DEVIATION NA • n=60 Participants • 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.
|
3.22 days
STANDARD_DEVIATION 7.57 • n=206 Participants • 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.
|
|
Overall quality of life (QoL)
|
NA score on a scale
STANDARD_DEVIATION NA • n=71 Participants • 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.
|
NA score on a scale
STANDARD_DEVIATION NA • n=72 Participants • 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.
|
NA score on a scale
STANDARD_DEVIATION NA • n=59 Participants • 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.
|
28.47 score on a scale
STANDARD_DEVIATION 6.46 • n=202 Participants • 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.
|
|
Physical subscale Quality of Life
|
NA score on a scale
STANDARD_DEVIATION NA • n=72 Participants • 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.
|
NA score on a scale
STANDARD_DEVIATION NA • n=74 Participants • 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.
|
NA score on a scale
STANDARD_DEVIATION NA • n=60 Participants • 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.
|
13.2 score on a scale
STANDARD_DEVIATION 3.01 • n=206 Participants • 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.
|
|
Mental subscale Quality of Life
|
NA score on a scale
STANDARD_DEVIATION NA • n=71 Participants • Participants dropped out of the study over the duration.
|
NA score on a scale
STANDARD_DEVIATION NA • n=73 Participants • Participants dropped out of the study over the duration.
|
NA score on a scale
STANDARD_DEVIATION NA • n=60 Participants • Participants dropped out of the study over the duration.
|
9.75 score on a scale
STANDARD_DEVIATION 2.99 • n=204 Participants • Participants dropped out of the study over the duration.
|
|
Number of hospitalizations
|
NA hospitalizations
STANDARD_DEVIATION NA • n=72 Participants • Participants dropped out of the study over the duration.
|
NA hospitalizations
STANDARD_DEVIATION NA • n=74 Participants • Participants dropped out of the study over the duration.
|
NA hospitalizations
STANDARD_DEVIATION NA • n=61 Participants • Participants dropped out of the study over the duration.
|
0.43 hospitalizations
STANDARD_DEVIATION 1.03 • n=207 Participants • Participants dropped out of the study over the duration.
|
|
Number of ER visits
|
NA ER visits
STANDARD_DEVIATION NA • n=72 Participants • Participants dropped out over the duration of the study.
|
NA ER visits
STANDARD_DEVIATION NA • n=74 Participants • Participants dropped out over the duration of the study.
|
NA ER visits
STANDARD_DEVIATION NA • n=61 Participants • Participants dropped out over the duration of the study.
|
1.10 ER visits
STANDARD_DEVIATION 2.79 • n=207 Participants • Participants dropped out over the duration of the study.
|
|
Any drink
|
NA participants
n=72 Participants • Participants dropped out over the duration of the study.
|
NA participants
n=74 Participants • Participants dropped out over the duration of the study.
|
NA participants
n=61 Participants • Participants dropped out over the duration of the study.
|
64 participants
n=207 Participants • Participants dropped out over the duration of the study.
|
|
Any drink or drug
|
NA participants
n=72 Participants • Participants dropped out of the study over time.
|
NA participants
n=74 Participants • Participants dropped out of the study over time.
|
NA participants
n=60 Participants • Participants dropped out of the study over time.
|
97 participants
n=206 Participants • Participants dropped out of the study over time.
|
|
Currently receive other addiction treatment
|
NA participants
n=72 Participants • Participants dropped out over time.
|
NA participants
n=74 Participants • Participants dropped out over time.
|
NA participants
n=61 Participants • Participants dropped out over time.
|
89 participants
n=207 Participants • Participants dropped out over time.
|
|
HIV risky behavior
|
NA participants
n=72 Participants • Participants dropped out over time.
|
NA participants
n=74 Participants • Participants dropped out over time.
|
NA participants
n=61 Participants • Participants dropped out over time.
|
76 participants
n=207 Participants • Participants dropped out over time.
|
|
HIV testing
|
NA participants
n=72 Participants • Participants dropped out over time.
|
NA participants
n=74 Participants • Participants dropped out over time.
|
NA participants
n=60 Participants • Participants dropped out over time.
|
81 participants
n=206 Participants • Participants dropped out over time.
|
|
Drug of choice is alcohol
|
34 Participants
n=97 Participants
|
44 Participants
n=100 Participants
|
27 Participants
n=71 Participants
|
105 Participants
n=268 Participants
|
|
Drug of choice is Opiates
|
31 Participants
n=97 Participants
|
14 Participants
n=100 Participants
|
8 Participants
n=71 Participants
|
53 Participants
n=268 Participants
|
|
Drug of choice is crack cocaine
|
9 Participants
n=97 Participants
|
3 Participants
n=100 Participants
|
11 Participants
n=71 Participants
|
23 Participants
n=268 Participants
|
|
Drug of choice is marijuana
|
1 Participants
n=97 Participants
|
4 Participants
n=100 Participants
|
16 Participants
n=71 Participants
|
21 Participants
n=268 Participants
|
|
Drug of choice is methamphetamine
|
0 Participants
n=97 Participants
|
15 Participants
n=100 Participants
|
1 Participants
n=71 Participants
|
16 Participants
n=268 Participants
|
|
Drug of choice is multiple drugs
|
22 Participants
n=97 Participants
|
20 Participants
n=100 Participants
|
8 Participants
n=71 Participants
|
50 Participants
n=268 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsPopulation: These are milestones achieved for each site.
The number of implementation milestones completed
Outcome measures
| Measure |
Seva - Madison Site
n=12 Milestones
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
n=12 Milestones
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
n=12 Milestones
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Implementation Status
|
12 milestones
|
12 milestones
|
12 milestones
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Outcome measures
| Measure |
Seva - Madison Site
n=207 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Any Drinking Days in Last 30 Days
|
1.67 days
Standard Deviation 4.69
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Analysis for measure was done for the total of all three sites combined.
Outcome measures
| Measure |
Seva - Madison Site
n=207 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Risky Drinking Days in the Last 30 Days
|
0.70 days
Standard Deviation 2.58
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Analysis for measure was done for the total of all three sites combined.
Outcome measures
| Measure |
Seva - Madison Site
n=206 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Illicit Drug-use Within the Last 30 Days
|
2.14 days
Standard Deviation 6.55
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Seva - Madison Site
n=202 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Overall Quality of Life
|
30.03 score on a scale
Standard Deviation 7.11
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Seva - Madison Site
n=206 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Physical Subscale Quality of Life
|
13.48 score on a scale
Standard Deviation 3.11
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Seva - Madison Site
n=204 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Mental Subscale Quality of Life
|
10.77 score on a scale
Standard Deviation 3.50
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Analysis for measure was done for the total of all three sites combined.
Outcome measures
| Measure |
Seva - Madison Site
n=207 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Patient Had Any Drink Within the Last 30 Days
|
51 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Analysis for measure was done for the total of all three sites combined.
Outcome measures
| Measure |
Seva - Madison Site
n=206 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Patient Had Illicit Drug Use Within the Last 30 Days
|
36 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Overall number of participants analyzed because data was self reported and patients were allowed to not answer questions if they chose.
Analysis for measure was done for the total of all three sites combined.
Outcome measures
| Measure |
Seva - Madison Site
n=204 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Patient Had Any Drink or Drug Use Within the Last 30 Days
|
69 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsAnalysis for measure was done for the total of all three sites combined.
Outcome measures
| Measure |
Seva - Madison Site
n=207 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Patients, Within the Last 6 Months Have Received Other Addiction Treatment
|
78 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsAnalysis for measure was done for the total of all three sites combined.
Outcome measures
| Measure |
Seva - Madison Site
n=207 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Patients Partook in HIV Risky Behavior in the Last 6 Months
|
65 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Overall number of participants analyzed is lower because data is self reported and patients could chose not to answer some questions.
Analysis for measure was done for the total of all three sites combined.
Outcome measures
| Measure |
Seva - Madison Site
n=206 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Patients Partook in HIV Testing in the Last 6 Months
|
116 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsAnalysis for measure was done for the total of all three sites combined.
Outcome measures
| Measure |
Seva - Madison Site
n=268 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Number of Patients Using System
|
268 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: This is the number of primary care clinical staff at the 3 sites who adopted using Seva.
We analyzed computerized system log files to produce patterns of system adoption of the staff.
Outcome measures
| Measure |
Seva - Madison Site
n=171 Participants
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Clinical Adoption
|
171 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome measure was analyzed at the clinic level. Thus, NA is indicated for "Overall number of participants analyzed."
This includes the clinic operating costs and clinic implementation costs of the intervention.
Outcome measures
| Measure |
Seva - Madison Site
n=1 clinic
We identified 12 milestones for to meet for each site.
|
Seva - Missoula
n=1 clinic
We identified 12 milestones for to meet for each site.
|
Seva - Bronx
n=1 clinic
We identified 12 milestones for to meet for each site.
|
|---|---|---|---|
|
Total Costs for Clinic
|
123584 US dollars
|
140495 US dollars
|
111298 US dollars
|
Adverse Events
Seva - Patients
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Seva - Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Seva - Patients
n=268 participants at risk
Patients will receive access to the Seva mobile health system for drug use disorders.
|
Seva - Clinicians
n=171 participants at risk
Clinicians who worked at Seva sites were also monitored for Adverse events.
|
|---|---|---|
|
General disorders
Death
|
0.37%
1/268 • Number of events 1 • Up to 1 year.
|
0.00%
0/171 • Up to 1 year.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place