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

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

Study Overview

• Status: Completed
• Conditions: HIV; Substance Use Disorders
• Intervention / Treatment: Behavioral: Seva

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.

• Study Type: Interventional
• Enrollment (Actual): 439
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Montana
    • Missoula, Montana, United States
      • Partnership Health Center
  • New York
    • Bronx, New York, United States
      • Institute for Family Health
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • UW Health Access Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seva; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA); Dartmouth College; Center for Health Enhancement System Studies

Publications and helpful links

General Publications

• Quanbeck A. Using Stakeholder Values to Promote Implementation of an Evidence-Based Mobile Health Intervention for Addiction Treatment in Primary Care Settings. JMIR Mhealth Uhealth. 2019 Jun 7;7(6):e13301. doi: 10.2196/13301.
• Mares ML, Gustafson DH, Glass JE, Quanbeck A, McDowell H, McTavish F, Atwood AK, Marsch LA, Thomas C, Shah D, Brown R, Isham A, Nealon MJ, Ward V. Implementing an mHealth system for substance use disorders in primary care: a mixed methods study of clinicians' initial expectations and first year experiences. BMC Med Inform Decis Mak. 2016 Sep 29;16(1):126. doi: 10.1186/s12911-016-0365-5.
• Quanbeck AR, Gustafson DH, Marsch LA, McTavish F, Brown RT, Mares ML, Johnson R, Glass JE, Atwood AK, McDowell H. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study. Implement Sci. 2014 May 29;9:65. doi: 10.1186/1748-5908-9-65.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2012-0937; R01DA034279-01 (U.S. NIH Grant/Contract)