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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Center for Health Enhancement System Studies
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Andrew Quanbeck, Center for Health Enhancement System Studies
ClinicalTrials.gov Identifier:
NCT01963234
First received: October 9, 2013
Last updated: May 12, 2015
Last verified: May 2015
  Purpose

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


Condition
Substance Use Disorders
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)

Further study details as provided by Center for Health Enhancement System Studies:

Primary Outcome Measures:
  • Implementation status [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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:
  • Number of patients using system [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Clinical adoption [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: March 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Seva
Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients of federally qualified health centers with drug use disorders.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963234

Contacts
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

Locations
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
Andrew Quanbeck
Dartmouth-Hitchcock Medical Center
  More Information

No publications provided by Center for Health Enhancement System Studies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew Quanbeck, Assistant Scientist, Center for Health Enhancement System Studies
ClinicalTrials.gov Identifier: NCT01963234     History of Changes
Other Study ID Numbers: R01 DA034279-01, R01DA034279-01
Study First Received: October 9, 2013
Last Updated: May 12, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2015