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

Study Overview
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Brief Summary
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Implementing a mobile-phone based system for drug use disorders in primary care settings.

Detailed Description
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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.

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

Conditions
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Substance Use Disorders, HIV

Intervention / Treatment
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* Behavioral: Seva


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seva<br>Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders. | Behavioral: Seva<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation Status | The number of implementation milestones completed | up to 3 years | 
| Any Drinking Days in Last 30 Days |  | 6 months | 
| Risky Drinking Days in the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | 6 months | 
| Illicit Drug-use Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| Patient Had Any Drink Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | 6 months | 
| Patient Had Illicit Drug Use Within the Last 30 Days | Analysis for measure was done for the total of all three sites combined. | 6 months | 
| 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. | 6 months | 
| Patients, Within the Last 6 Months Have Received Other Addiction Treatment | Analysis for measure was done for the total of all three sites combined. | 6 months | 
| Patients Partook in HIV Risky Behavior in the Last 6 Months | Analysis for measure was done for the total of all three sites combined. | 6 months | 
| Patients Partook in HIV Testing in the Last 6 Months | Analysis for measure was done for the total of all three sites combined. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Using System | Analysis for measure was done for the total of all three sites combined. | up to 3 years | 
| Clinical Adoption | We analyzed computerized system log files to produce patterns of system adoption of the staff. | up to 3 years | 
| Total Costs for Clinic | This includes the clinic operating costs and clinic implementation costs of the intervention. | 6 months |