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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

October 9, 2013
October 16, 2013
February 28, 2018
July 31, 2018
July 31, 2018
March 2014
June 30, 2017   (Final data collection date for primary outcome measure)
  • Implementation Status [ Time Frame: up to 3 years ]
    The number of implementation milestones completed
  • Any Drinking Days in Last 30 Days [ Time Frame: 6 months ]
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Implementation status [ Time Frame: up to 3 years ]
To measure implementation progress, we will adapt our implementation model intervention into a specific implementation plan (including timetables) for each clinic. We employ the Stages of Implementation Completion model (Chamberlain et al., 2011) to assess the degree of implementation. Each of the 8 phases of the implementation completion model is prospectively broken down into discrete tasks and events. We will assess whether each task/event was implemented and the length of time each one took to implement. Starting at the beginning of the implementation planning period (4 months before the first patient accesses Seva), the checklist will be reviewed and updated monthly by the implementation program leader, with responses verified by the clinic coach.
Complete list of historical versions of study NCT01963234 on ClinicalTrials.gov Archive Site
  • Number of Patients Using System [ Time Frame: up to 3 years ]
    Analysis for measure was done for the total of all three sites combined.
  • Clinical Adoption [ Time Frame: up to 3 years ]
    We analyzed computerized system log files to produce patterns of system adoption of the staff.
  • Total Costs for Clinic [ Time Frame: 6 months ]
    This includes the clinic operating costs and clinic implementation costs of the intervention.
  • Number of Patients Using System [ Time Frame: up to 3 years ]
  • Clinical Adoption [ Time Frame: up to 3 years ]
    We will analyze computerized system log files to produce metrics about patterns of system adoption by patients and staff. We will assess the characteristics of staff members (job function, years with clinic, etc.) and patients (age, gender, race, etc.) to determine individual characteristics associated with the degree of adoption.
Not Provided
Not Provided
 
Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Substance Use Disorders
  • HIV
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.
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.
Intervention: Behavioral: Seva

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
439
Not Provided
June 30, 2017
June 30, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01963234
2012-0937
R01DA034279-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
  • National Institute on Drug Abuse (NIDA)
  • Dartmouth College
  • Center for Health Enhancement System Studies
Not Provided
University of Wisconsin, Madison
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP