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Completed

NCT Number: NCT01963234

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

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

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders HIV Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Partnership Health Center, Missoula, Montana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seva

Behavioral

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.

Primary outcomes

  1. Implementation Status

    Time frame: up to 3 years

    The number of implementation milestones completed

  2. Any Drinking Days in Last 30 Days

    Time frame: 6 months

  3. Risky Drinking Days in the Last 30 Days

    Time frame: 6 months

    Analysis for measure was done for the total of all three sites combined.

  4. Illicit Drug-use Within the Last 30 Days

    Time frame: 6 months

    Analysis for measure was done for the total of all three sites combined.

  5. Overall Quality of Life

    Time frame: 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.

  6. Physical Subscale Quality of Life

    Time frame: 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.

  7. Mental Subscale Quality of Life

    Time frame: 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.

  8. Patient Had Any Drink Within the Last 30 Days

    Time frame: 6 months

    Analysis for measure was done for the total of all three sites combined.

  9. Patient Had Illicit Drug Use Within the Last 30 Days

    Time frame: 6 months

    Analysis for measure was done for the total of all three sites combined.

  10. Patient Had Any Drink or Drug Use Within the Last 30 Days

    Time frame: 6 months

    Analysis for measure was done for the total of all three sites combined.

  11. Patients, Within the Last 6 Months Have Received Other Addiction Treatment

    Time frame: 6 months

    Analysis for measure was done for the total of all three sites combined.

  12. Patients Partook in HIV Risky Behavior in the Last 6 Months

    Time frame: 6 months

    Analysis for measure was done for the total of all three sites combined.

  13. Patients Partook in HIV Testing in the Last 6 Months

    Time frame: 6 months

    Analysis for measure was done for the total of all three sites combined.

Secondary outcomes

  1. Number of Patients Using System

    Time frame: up to 3 years

    Analysis for measure was done for the total of all three sites combined.

  2. Clinical Adoption

    Time frame: up to 3 years

    We analyzed computerized system log files to produce patterns of system adoption of the staff.

  3. Total Costs for Clinic

    Time frame: 6 months

    This includes the clinic operating costs and clinic implementation costs of the intervention.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Center for Health Enhancement System Studies
  • Dartmouth College
  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: Seva

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2013
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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