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

HIV Clinical Trial

— Seva  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963234
• Other study ID #: 2012-0937
• Secondary ID: R01DA034279-01
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Institute for Family Health	Bronx	New York
United States	UW Health Access Clinic	Madison	Wisconsin
United States	Partnership Health Center	Missoula	Montana

Sponsors (4)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Center for Health Enhancement System Studies, Dartmouth College, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation Status	The number of implementation milestones completed	up to 3 years
Primary	Any Drinking Days in Last 30 Days		6 months
Primary	Risky Drinking Days in the Last 30 Days	Analysis for measure was done for the total of all three sites combined.	6 months
Primary	Illicit Drug-use Within the Last 30 Days	Analysis for measure was done for the total of all three sites combined.	6 months
Primary	Overall Quality of Life	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.	6 months
Primary	Physical Subscale Quality of Life	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.	6 months
Primary	Mental Subscale Quality of Life	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.	6 months
Primary	Patient Had Any Drink Within the Last 30 Days	Analysis for measure was done for the total of all three sites combined.	6 months
Primary	Patient Had Illicit Drug Use Within the Last 30 Days	Analysis for measure was done for the total of all three sites combined.	6 months
Primary	Patient Had Any Drink or Drug Use Within the Last 30 Days	Analysis for measure was done for the total of all three sites combined.	6 months
Primary	Patients, Within the Last 6 Months Have Received Other Addiction Treatment	Analysis for measure was done for the total of all three sites combined.	6 months
Primary	Patients Partook in HIV Risky Behavior in the Last 6 Months	Analysis for measure was done for the total of all three sites combined.	6 months
Primary	Patients Partook in HIV Testing in the Last 6 Months	Analysis for measure was done for the total of all three sites combined.	6 months
Secondary	Number of Patients Using System	Analysis for measure was done for the total of all three sites combined.	up to 3 years
Secondary	Clinical Adoption	We analyzed computerized system log files to produce patterns of system adoption of the staff.	up to 3 years
Secondary	Total Costs for Clinic	This includes the clinic operating costs and clinic implementation costs of the intervention.	6 months