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

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ClinicalTrials.gov Identifier: NCT01963234
Recruitment Status : Completed
First Posted : October 16, 2013
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Dartmouth College
Center for Health Enhancement System Studies
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

Condition or disease Intervention/treatment Phase
Substance Use Disorders HIV Behavioral: Seva Not Applicable

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  (Clinical Trial)
Actual Enrollment : 439 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
Actual Study Start Date : March 2014
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963234


Locations
United States, Montana
Partnership Health Center
Missoula, Montana, United States
United States, New York
Institute for Family Health
Bronx, New York, United States
United States, Wisconsin
UW Health Access Clinic
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
Dartmouth College
Center for Health Enhancement System Studies
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison: