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

This study is currently recruiting participants.
Verified October 2016 by University of Wisconsin, Madison
Sponsor:
ClinicalTrials.gov Identifier:
NCT01963234
First Posted: October 16, 2013
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
Dartmouth-Hitchcock Medical Center
Center for Health Enhancement System Studies
Information provided by (Responsible Party):
University of Wisconsin, Madison
October 9, 2013
October 16, 2013
October 27, 2016
March 2014
June 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01963234 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients of federally qualified health centers with drug use disorders.
  • Substance Use Disorders
  • HIV
Not Provided
Seva
Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2017
June 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, Senior)
Yes
Contact: Fiona M McTavish, MS 608-262-7852 fiona.mctavish@chess.wisc.edu
Contact: Andrew R Quanbeck, Ph.D. 608-890-1016 andrew.quanbeck@chess.wisc.edu
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-Hitchcock Medical Center
  • Center for Health Enhancement System Studies
Not Provided
University of Wisconsin, Madison
October 2016