We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01963234
Recruitment Status : Recruiting
First Posted : October 16, 2013
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):

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

Condition or disease
Substance Use Disorders HIV

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 Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
Study Start Date : March 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017
Groups and Cohorts

Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Number of patients using system [ Time Frame: up to 3 years ]
  2. 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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients of federally qualified health centers with drug use disorders.

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.
Contacts and Locations

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

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, Montana
Partnership Health Center Recruiting
Missoula, Montana, United States
Contact: MaryJane Nealon, RN MFA         
United States, New York
Institute for Family Health Recruiting
Bronx, New York, United States
Contact: Victoria Ward         
United States, Wisconsin
UW Health Access Clinic Recruiting
Madison, Wisconsin, United States, 53706
Contact: Randall Brown, M.D.    608-333-3292      
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
Dartmouth-Hitchcock Medical Center
Center for Health Enhancement System Studies