Clinical trial NCT01963234: Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
Official title: Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
HIV
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Dartmouth College
name: Center for Health Enhancement System Studies
First posted: 2013-10-16
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Implementation Status
timeFrame: up to 3 years
measure: Any Drinking Days in Last 30 Days
timeFrame: 6 months
measure: Risky Drinking Days in the Last 30 Days
timeFrame: 6 months
measure: Illicit Drug-use Within the Last 30 Days
timeFrame: 6 months
measure: Overall Quality of Life
timeFrame: 6 months
measure: Physical Subscale Quality of Life
timeFrame: 6 months
measure: Mental Subscale Quality of Life
timeFrame: 6 months
measure: Patient Had Any Drink Within the Last 30 Days
timeFrame: 6 months
measure: Patient Had Illicit Drug Use Within the Last 30 Days
timeFrame: 6 months
measure: Patient Had Any Drink or Drug Use Within the Last 30 Days
timeFrame: 6 months
measure: Patients, Within the Last 6 Months Have Received Other Addiction Treatment
timeFrame: 6 months
measure: Patients Partook in HIV Risky Behavior in the Last 6 Months
timeFrame: 6 months
measure: Patients Partook in HIV Testing in the Last 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Patients Using System
timeFrame: up to 3 years
measure: Clinical Adoption
timeFrame: up to 3 years
measure: Total Costs for Clinic
timeFrame: 6 months
Other outcomes:
Locations:
city: Missoula
country: United States
facility: Partnership Health Center
state: Montana
city: Bronx
country: United States
facility: Institute for Family Health
state: New York
city: Madison
country: United States
facility: UW Health Access Clinic
state: Wisconsin
Study officials:
References:
citation: Quanbeck A. Using Stakeholder Values to Promote Implementation of an Evidence-Based Mobile Health Intervention for Addiction Treatment in Primary Care Settings. JMIR Mhealth Uhealth. 2019 Jun 7;7(6):e13301. doi: 10.2196/13301.
citation: Mares ML, Gustafson DH, Glass JE, Quanbeck A, McDowell H, McTavish F, Atwood AK, Marsch LA, Thomas C, Shah D, Brown R, Isham A, Nealon MJ, Ward V. Implementing an mHealth system for substance use disorders in primary care: a mixed methods study of clinicians' initial expectations and first year experiences. BMC Med Inform Decis Mak. 2016 Sep 29;16(1):126. doi: 10.1186/s12911-016-0365-5.
citation: Quanbeck AR, Gustafson DH, Marsch LA, McTavish F, Brown RT, Mares ML, Johnson R, Glass JE, Atwood AK, McDowell H. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study. Implement Sci. 2014 May 29;9:65. doi: 10.1186/1748-5908-9-65.