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

Primary Purpose

Substance Use Disorders, HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seva
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Partnership Health Center
  • Institute for Family Health
  • UW Health Access Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Seva

Arm Description

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

Outcomes

Primary Outcome Measures

Implementation Status
The number of implementation milestones completed
Any Drinking Days in Last 30 Days
Risky Drinking Days in the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Illicit Drug-use Within the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
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.
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.
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.
Patient Had Any Drink Within the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Patient Had Illicit Drug Use Within the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
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.
Patients, Within the Last 6 Months Have Received Other Addiction Treatment
Analysis for measure was done for the total of all three sites combined.
Patients Partook in HIV Risky Behavior in the Last 6 Months
Analysis for measure was done for the total of all three sites combined.
Patients Partook in HIV Testing in the Last 6 Months
Analysis for measure was done for the total of all three sites combined.

Secondary Outcome Measures

Number of Patients Using System
Analysis for measure was done for the total of all three sites combined.
Clinical Adoption
We analyzed computerized system log files to produce patterns of system adoption of the staff.
Total Costs for Clinic
This includes the clinic operating costs and clinic implementation costs of the intervention.

Full Information

First Posted
October 9, 2013
Last Updated
July 3, 2018
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA), Dartmouth College, Center for Health Enhancement System Studies
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1. Study Identification

Unique Protocol Identification Number
NCT01963234
Brief Title
Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
Acronym
Seva
Official Title
Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA), Dartmouth College, Center for Health Enhancement System Studies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seva
Arm Type
Experimental
Arm Description
Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.
Intervention Type
Behavioral
Intervention Name(s)
Seva
Intervention Description
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.
Primary Outcome Measure Information:
Title
Implementation Status
Description
The number of implementation milestones completed
Time Frame
up to 3 years
Title
Any Drinking Days in Last 30 Days
Time Frame
6 months
Title
Risky Drinking Days in the Last 30 Days
Description
Analysis for measure was done for the total of all three sites combined.
Time Frame
6 months
Title
Illicit Drug-use Within the Last 30 Days
Description
Analysis for measure was done for the total of all three sites combined.
Time Frame
6 months
Title
Overall Quality of Life
Description
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.
Time Frame
6 months
Title
Physical Subscale Quality of Life
Description
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.
Time Frame
6 months
Title
Mental Subscale Quality of Life
Description
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.
Time Frame
6 months
Title
Patient Had Any Drink Within the Last 30 Days
Description
Analysis for measure was done for the total of all three sites combined.
Time Frame
6 months
Title
Patient Had Illicit Drug Use Within the Last 30 Days
Description
Analysis for measure was done for the total of all three sites combined.
Time Frame
6 months
Title
Patient Had Any Drink or Drug Use Within the Last 30 Days
Description
Analysis for measure was done for the total of all three sites combined.
Time Frame
6 months
Title
Patients, Within the Last 6 Months Have Received Other Addiction Treatment
Description
Analysis for measure was done for the total of all three sites combined.
Time Frame
6 months
Title
Patients Partook in HIV Risky Behavior in the Last 6 Months
Description
Analysis for measure was done for the total of all three sites combined.
Time Frame
6 months
Title
Patients Partook in HIV Testing in the Last 6 Months
Description
Analysis for measure was done for the total of all three sites combined.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Patients Using System
Description
Analysis for measure was done for the total of all three sites combined.
Time Frame
up to 3 years
Title
Clinical Adoption
Description
We analyzed computerized system log files to produce patterns of system adoption of the staff.
Time Frame
up to 3 years
Title
Total Costs for Clinic
Description
This includes the clinic operating costs and clinic implementation costs of the intervention.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Partnership Health Center
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Institute for Family Health
City
Bronx
State/Province
New York
Country
United States
Facility Name
UW Health Access Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31237841
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.
Results Reference
derived
PubMed Identifier
27687632
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.
Results Reference
derived
PubMed Identifier
24884976
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.
Results Reference
derived

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

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