Omni Outcomes Report on Impact of Soberlink in Treatment

Executive Summary

Background

Data Collected and Participants

The study collected data on patient demographics, substance use, medical outcomes, and satisfaction with the Soberlink device. Throughout the study period, participants used the Soberlink device to monitor their BAC at least twice per day. Forty-two patients from Aware Recovery Care participated in the study for the full six-month duration. Sixty-seven percent of participants identified as male and the average age was 45 years old.

Key Findings

Omni Outcomes Report on Impact of Soberlink in Treatment

Study Overview

Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). The Soberlink device is a professional grade handheld breathalyzer with wireless connectivity, real-time facial recognition, robust tamper detection, and real-time alerting. See Appendix A for more information about the Soberlink device. Soberlink partnered with Aware Recovery Care, an organization that provides in-home substance use disorder treatment, to conduct a longitudinal outcomes study to better understand the impact of the Soberlink device.

The OMNI Institute served as the research partner and provided support with data collection, analysis, and reporting. OMNI is a non-profit research and evaluation consultancy with the mission of accelerating positive social change by supporting the public, nonprofit, and philanthropic sectors around the country with integrated research and evaluation, capacity building, and data utilization solutions. OMNI has more than four decades of experience conducting research and implementing best practices as they relate to substance use disorder treatment.

Soberlink and Aware Recovery Care's study collected data related to patient demographics, substance use, medical outcomes, Soberlink testing data, and satisfaction with the Soberlink device. Patients (participants) were asked to complete a baseline survey and monthly follow-up surveys for six-months after enrollment. The study protocol and materials were reviewed and approved by an Institutional Review Board (IRB). Data collection began in April 2019 and was completed in June 2020. A total of 87 individuals participated in the study.

Methods

At the time of enrollment in the Aware Recovery Care program, patients were assessed to determine if they met the study criteria. There were twelve enrollment criteria:

Between 21-75 years old
Admitted to the program with an American Society of Addiction Medicine (ASAM) score of 1.5-2.5
Primary or secondary Alcohol Use Disorder (AUD) diagnosis
Willing to use the Soberlink device
Willing to discuss Soberlink test results with Aware Recovery Care Team
Willing to sign a Soberlink Client Agreement
English speaking and reading
Residing in the US for the duration of the study
Not using anti-alcohol/craving medications (e.g. Antabuse, Campral, Vivitrol)
Not cognitively impaired or diagnosed with a mental health disorder involving depersonalization or active psychotic symptoms
Not in active withdrawal or alcohol use within 72 hours
Not using Soberlink data for a child custody or legal consequence

In addition to the survey measures, research staff also compiled data from the Soberlink device. Participants were required to use the Soberlink device during pre-determined testing times at least twice per day. Participants were given a 2-hour test window and a 1-hour late grace period to submit the test. Finally, administrative medical outcomes data were also collected as part of the study including number of ER visits, hospitalizations, detox program admissions, and residential program admissions during the study period.

The Brief Addiction Monitor¹ (BAM) is a 17-item measure of substance use severity. It includes items that assess risk factors for substance use, protective factors that support sobriety, and self-reported substance use. This tool was originally developed by Veterans Affairs (VA) with items from valid and reliable measures. In this study, the BAM was administered at baseline and every month throughout the study for a total of seven timepoints.
The Soberlink Use survey² is an 11-item survey that is designed to assess satisfaction with the Soberlink device. This survey was administered to participants at the end of the study.
Primary or secondary Alcohol Use Disorder (AUD) diagnosis

Study Participants

Of the 87 participants who enrolled in the study, 42 (48%) participated in the study for the full six-month duration of the study (178 - 205 days) and are included in the analysis of this report. Forty-five (52%) participants did not complete the study for the following reasons:

1 Cacciola, J. S., Alterman, A. I., Dephilippis, D., Drapkin, M. L., Valadez, C., Jr, Fala, N. C., Oslin, D., & McKay, J. R. (2013). Development and initial evaluation of the Brief Addiction Monitor (BAM). Journal of substance abuse treatment, 44(3), 256–263. https://doi.org/10.1016/j.jsat.2012.07.013
2 This survey was developed by Soberlink
3 This survey was developed by Aware Recovery Care

Findings

Soberlink Testing Data

Throughout the study period, participants used the Soberlink device to monitor their BAC at least twice per day. The results of each test were categorized as negative if their BAC was zero, positive if their BAC was greater than zero or their identity was not confirmed via facial recognition, or missed if they did not complete the test during the specified time period.

Medical Outcomes

The Aware Recovery Care Team tracked participants' medical outcomes over the study period. Most participants did not need medical care during the study. During the six-month study period:

Four (10%) of the 42 participants visited an emergency room one or two times
Four (10%) of the participants were admitted into the hospital
Two (5%) of the participants were admitted into a residential treatment program

4 The average number of negative tests was 409 (range from 165 to 712), missed tests was 71 (range from 0 to 381), and positive tests was 4 (range from 0 to 37).

Survey Outcomes

Brief Addiction Monitor (BAM) Survey

The Brief Addiction Monitor (BAM) is a 17-item measure of substance use severity. The BAM was administered at baseline and every month throughout the study for a total of seven timepoints. The items are divided into three sub-scales that assess substance use, risk factors for substance use, and protective factors that support sobriety. A copy of the BAM survey can be found in Appendix B.

Participants' substance use decreased between baseline and the 1-month follow-up and stayed low through all follow-up time points.
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‍The substance use subscale scores range from 0 to 12 with higher scores indicating more substance use.

Participants' risk factors associated with substance use decreased between baseline and the 1-month follow-up and stayed low through all follow-up time points.
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The risk factor subscale scores range from 0 to 24 with higher scores indicating greater risk.

Participants' protective factors associated with substance use were similar across all time points.
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The protective factors subscale scores range from 0 to 24 with higher scores indicating greater protection.

Soberlink Satisfaction Survey

Participants were asked to rate 11 statements about the Soberlink device on a five-point scale (1 = Strongly disagree, 2 = Somewhat disagree, 3 = Neither agree or disagree, 4 = Agree, 5 = Strongly agree). The following figure displays the percentage of participants who selected 'agree' or 'strongly agree' for each statement. A copy of the Soberlink satisfaction survey can be found in Appendix B.

Participants reported positive feelings about the Soberlink device across all 11 satisfaction survey items.
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Each bar represents the percentage of participants who selected 'agree' or 'strongly agree' for each statement.

Positive Outcome Measure Survey

The Positive Outcome Measures survey is a 9-item measure of program engagement at Aware Recovery Care. Participants responded 'yes', 'no', or 'not applicable' for each item. This survey was administered twice, at baseline and at the end of the study. The number of 'yes' responses were averaged to create a composite measure of the survey. A copy of the POM survey can be found in Appendix B.

The average number of positive outcomes that participants reported increased between baselineand follow-up.
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The number of possible positive outcomes ranged from 0 to 9.

The percentage of participants who responded 'yes' on each of the items on the Positive Outcome Measure Survey at baseline and follow-up are reflected below. Participants indicated positive change on all items from baseline to follow-up except on two items:

100% of participants indicated they felt supported by the Aware Recovery Care Team at both baseline and follow-up
Two clients (5%) indicated they "obtained legal charges since starting the program" at follow-up

The percentage of participants who selected 'yes' for each of the following positive outcomes increased from baseline to follow-up.

Conclusion

Soberlink, in partnership with Aware Recovery Care, engaged in a longitudinal outcomes study to better understand the impact of the Soberlink device in an in-home treatment setting. Forty-two individuals participated in the study for the full six-month duration and provided Soberlink testing data, medical outcome data, and survey data.

Summary of Findings

The majority of study participants identified as male and the average participant age was 45 years old. On average, participants consumed alcohol three times during the study period. Only 1% of Soberlink test results were positive, 85% were negative, and 14% were missed. While the majority of participants did not need medical attention during the study period, 10% visited the emergency room, 10% were admitted to the hospital and 5% were admitted into a residential program. Substance use was also assessed via the BAM survey. Self-reported substance use decreased between baseline and the 1-month follow-up and stayed low through all follow-up time points. There was also a decrease in risk factors associated with substance use between baseline and the 1-month follow-up. These risk factors also stayed low throughout the follow-up time points. Participants reported a high level of satisfaction with the Soberlink device and reported more positive outcomes at the end of the study compared to the beginning of the study.

Limitations

While every effort was made to collect data from all participants, some participants did not complete all surveys. In addition, there were twelve criteria to participate in this study. The sample of participants recruited for this study is a convenience sample and may not be representative of all patients at Aware Recovery Care or generalizable to other populations. Finally, participants self-reported on their feelings and behaviors on the study surveys. Participants may not respond accurately or truthfully due to memory or social desirability biases.

Recommendations for Next Steps

Soberlink seeks to become an evidence-based tool supported through outcomes data that demonstrates benefits to individuals with an Alcohol Use Disorder (AUD). The current study provides initial evidence that Soberlink positively impacts individuals seeking treatment for alcohol use, including sustained reduced alcohol use and positive whole health outcomes such as improved relationships, employment/school engagement, and management of health and stress. In addition, the Soberlink satisfaction survey suggest that individuals view the device positively and would recommend it to others.

Future research efforts may explore Soberlink's impact in other clinical contexts (for example in other outpatient treatment models or after discharge from residential treatment), examine other patient populations, or attempt to evaluate the impact of using the Soberlink device for individuals who do not seek formal treatment. Furthermore, future research could pursue more robust study methodology such as a randomized controlled trial of the Soberlink device (randomly assigning individuals to use or not use the device) to continue to build a body of evidence regarding the efficacy of Soberlink.

Impact of Soberlink in In-Home Substance Use Treatment