HIV, Substance Use Disorders
Conditions
Brief summary
Implementing a mobile-phone based system for drug use disorders in primary care settings.
Detailed description
The purpose of the research is to study the impact of a recovery support system called Seva on primary care organizations, where issues such as coordination of care, job satisfaction, and the cost of adopting and operating new technologies are critical. The study will also investigate how to best implement this kind of technology into health care delivery systems that care for people diagnosed with substance abuse.
Interventions
BEHAVIORALSeva
Patients were given access to use Seva. This is a mobile application that uses social and behavioral theories to help support people after alcohol use disorder recovery.
Sponsors
National Institute on Drug Abuse (NIDA)
Dartmouth College
Center for Health Enhancement System Studies
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient subjects must be 1) age 18 or older 2) meet criteria for Substance Use Disorder (SUD) according to the clinic. Clinician subjects referring patients will ensure that patients: 3) have no current psychotic disorder severe enough to prevent participation, 4) have no acute medical problem requiring immediate inpatient treatment, 5) are willing to use Seva, and 6) can understand and sign a consent form in English. Clinician subjects include MDs, behavioral health providers, nurses and management staff from the clinics' primary care and behavioral health departments. Clinician must have an interest in the research objectives.
Exclusion criteria
* Failure to meet inclusion criteria above will exclude patients and clinicians from participating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Partook in HIV Testing in the Last 6 Months | 6 months | Analysis for measure was done for the total of all three sites combined. |
| Patient Had Any Drink or Drug Use Within the Last 30 Days | 6 months | Analysis for measure was done for the total of all three sites combined. |
| Patients, Within the Last 6 Months Have Received Other Addiction Treatment | 6 months | Analysis for measure was done for the total of all three sites combined. |
| Patients Partook in HIV Risky Behavior in the Last 6 Months | 6 months | Analysis for measure was done for the total of all three sites combined. |
| Implementation Status | up to 3 years | The number of implementation milestones completed |
| Any Drinking Days in Last 30 Days | 6 months | — |
| Risky Drinking Days in the Last 30 Days | 6 months | Analysis for measure was done for the total of all three sites combined. |
| Illicit Drug-use Within the Last 30 Days | 6 months | Analysis for measure was done for the total of all three sites combined. |
| Overall Quality of Life | 6 months | 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. |
| Physical Subscale Quality of Life | 6 months | 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. |
| Mental Subscale Quality of Life | 6 months | 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. |
| Patient Had Any Drink Within the Last 30 Days | 6 months | Analysis for measure was done for the total of all three sites combined. |
| Patient Had Illicit Drug Use Within the Last 30 Days | 6 months | Analysis for measure was done for the total of all three sites combined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Adoption | up to 3 years | We analyzed computerized system log files to produce patterns of system adoption of the staff. |
| Total Costs for Clinic | 6 months | This includes the clinic operating costs and clinic implementation costs of the intervention. |
| Number of Patients Using System | up to 3 years | Analysis for measure was done for the total of all three sites combined. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 97 |
| 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. | 100 |
| 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. | 71 |
| Total | 268 |
Baseline characteristics
| Characteristic | Total | Seva - Missoula | Seva - Bronx | Seva - Madison Site |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 268 Participants | 100 Participants | 71 Participants | 97 Participants |
| Any drink | 64 participants | NA participants | NA participants | NA participants |
| Any drinking days | 2.53 days STANDARD_DEVIATION 6.01 | NA days | NA days | NA days |
| Any drink or drug | 97 participants | NA participants | NA participants | NA participants |
| Currently receive other addiction treatment | 89 participants | NA participants | NA participants | NA participants |
| Drug of choice is alcohol | 105 Participants | 44 Participants | 27 Participants | 34 Participants |
| Drug of choice is crack cocaine | 23 Participants | 3 Participants | 11 Participants | 9 Participants |
| Drug of choice is marijuana | 21 Participants | 4 Participants | 16 Participants | 1 Participants |
| Drug of choice is methamphetamine | 16 Participants | 15 Participants | 1 Participants | 0 Participants |
| Drug of choice is multiple drugs | 50 Participants | 20 Participants | 8 Participants | 22 Participants |
| Drug of choice is Opiates | 53 Participants | 14 Participants | 8 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 2 Participants | 35 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 230 Participants | 98 Participants | 36 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HIV risky behavior | 76 participants | NA participants | NA participants | NA participants |
| HIV testing | 81 participants | NA participants | NA participants | NA participants |
| Illicit drug use | 63 participants | NA participants | NA participants | NA participants |
| Illicit drug-use days | 3.22 days STANDARD_DEVIATION 7.57 | NA days | NA days | NA days |
| Insured by medicaid | 111 Participants | 23 Participants | 33 Participants | 55 Participants |
| Insured by medicare | 28 Participants | 12 Participants | 8 Participants | 8 Participants |
| Insured by private/other | 57 Participants | 19 Participants | 20 Participants | 18 Participants |
| Mental subscale Quality of Life | 9.75 score on a scale STANDARD_DEVIATION 2.99 | NA score on a scale | NA score on a scale | NA score on a scale |
| Not insured | 72 Participants | 46 Participants | 10 Participants | 16 Participants |
| Number of ER visits | 1.10 ER visits STANDARD_DEVIATION 2.79 | NA ER visits | NA ER visits | NA ER visits |
| Number of hospitalizations | 0.43 hospitalizations STANDARD_DEVIATION 1.03 | NA hospitalizations | NA hospitalizations | NA hospitalizations |
| Overall quality of life (QoL) | 28.47 score on a scale STANDARD_DEVIATION 6.46 | NA score on a scale | NA score on a scale | NA score on a scale |
| Patient-centered medical home (PCMH) designation | NA Level | 3 Level | 3 Level | 3 Level |
| Patients enrolled in Seva | 268 Participants | 100 Participants | 71 Participants | 97 Participants |
| Physical subscale Quality of Life | 13.2 score on a scale STANDARD_DEVIATION 3.01 | NA score on a scale | NA score on a scale | NA score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 13 Participants | 8 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 67 Participants | 2 Participants | 35 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 0 Participants | 11 Participants | 0 Participants |
| Race (NIH/OMB) White | 176 Participants | 89 Participants | 24 Participants | 63 Participants |
| Region of Enrollment United States | 268 participants | 100 participants | 71 participants | 97 participants |
| Risky drinking days | 1.25 days STANDARD_DEVIATION 3.78 | NA days | NA days | NA days |
| Sex: Female, Male Female | 127 Participants | 40 Participants | 35 Participants | 52 Participants |
| Sex: Female, Male Male | 141 Participants | 60 Participants | 36 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 268 | 0 / 171 |
| other Total, other adverse events | 0 / 268 | 0 / 171 |
| serious Total, serious adverse events | 3 / 268 | 0 / 171 |
Outcome results
Primary
Any Drinking Days in Last 30 Days
Time frame: 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seva - Madison Site | Any Drinking Days in Last 30 Days | 1.67 days | Standard Deviation 4.69 |
Primary
Illicit Drug-use Within the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Time frame: 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seva - Madison Site | Illicit Drug-use Within the Last 30 Days | 2.14 days | Standard Deviation 6.55 |
Primary
Implementation Status
The number of implementation milestones completed
Time frame: up to 3 years
Population: These are milestones achieved for each site.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seva - Madison Site | Implementation Status | 12 milestones |
| Seva - Missoula | Implementation Status | 12 milestones |
| Seva - Bronx | Implementation Status | 12 milestones |
Primary
Mental Subscale Quality of Life
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seva - Madison Site | Mental Subscale Quality of Life | 10.77 score on a scale | Standard Deviation 3.5 |
Primary
Overall Quality of Life
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seva - Madison Site | Overall Quality of Life | 30.03 score on a scale | Standard Deviation 7.11 |
Primary
Patient Had Any Drink or Drug Use Within the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Time frame: 6 months
Population: Overall number of participants analyzed because data was self reported and patients were allowed to not answer questions if they chose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Seva - Madison Site | Patient Had Any Drink or Drug Use Within the Last 30 Days | 69 Participants |
Primary
Patient Had Any Drink Within the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Time frame: 6 months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Seva - Madison Site | Patient Had Any Drink Within the Last 30 Days | 51 Participants |
Primary
Patient Had Illicit Drug Use Within the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Time frame: 6 months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Seva - Madison Site | Patient Had Illicit Drug Use Within the Last 30 Days | 36 Participants |
Primary
Patients Partook in HIV Risky Behavior in the Last 6 Months
Analysis for measure was done for the total of all three sites combined.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Seva - Madison Site | Patients Partook in HIV Risky Behavior in the Last 6 Months | 65 Participants |
Primary
Patients Partook in HIV Testing in the Last 6 Months
Analysis for measure was done for the total of all three sites combined.
Time frame: 6 months
Population: Overall number of participants analyzed is lower because data is self reported and patients could chose not to answer some questions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Seva - Madison Site | Patients Partook in HIV Testing in the Last 6 Months | 116 Participants |
Primary
Patients, Within the Last 6 Months Have Received Other Addiction Treatment
Analysis for measure was done for the total of all three sites combined.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Seva - Madison Site | Patients, Within the Last 6 Months Have Received Other Addiction Treatment | 78 Participants |
Primary
Physical Subscale Quality of Life
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seva - Madison Site | Physical Subscale Quality of Life | 13.48 score on a scale | Standard Deviation 3.11 |
Primary
Risky Drinking Days in the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Time frame: 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seva - Madison Site | Risky Drinking Days in the Last 30 Days | 0.70 days | Standard Deviation 2.58 |
Secondary
Clinical Adoption
We analyzed computerized system log files to produce patterns of system adoption of the staff.
Time frame: up to 3 years
Population: This is the number of primary care clinical staff at the 3 sites who adopted using Seva.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Seva - Madison Site | Clinical Adoption | 171 Participants |
Secondary
Number of Patients Using System
Analysis for measure was done for the total of all three sites combined.
Time frame: up to 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Seva - Madison Site | Number of Patients Using System | 268 Participants |
Secondary
Total Costs for Clinic
This includes the clinic operating costs and clinic implementation costs of the intervention.
Time frame: 6 months
Population: This outcome measure was analyzed at the clinic level. Thus, NA is indicated for Overall number of participants analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Seva - Madison Site | Total Costs for Clinic | 123584 US dollars |
| Seva - Missoula | Total Costs for Clinic | 140495 US dollars |
| Seva - Bronx | Total Costs for Clinic | 111298 US dollars |