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SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers (ST@T)

Primary Purpose

Alcohol-induced Disorders, Drug Users, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The brief interventions are delivered by behavioral health counselors (Specialist)
The brief interventions are delivered by the primary care provider (Generalist)
Sponsored by
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol-induced Disorders focused on measuring implementation, SBIRT, alcohol screening, drug screening, Brief Intervention, Referral to Treatment, adolescents, Federally Qualified Health Centers

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • clinic staff

Exclusion Criteria:

-

Sites / Locations

  • Total Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Specialist

Generalist

Arm Description

The brief interventions are delivered by behavioral health counselors.

The brief interventions are delivered by the primary care provider.

Outcomes

Primary Outcome Measures

Penetration of BI within the Generalist and Specialist models
To examine the relative effectiveness of the Generalist condition v. the Specialist condition in terms of penetration of brief intervention (proportion of patients receiving brief intervention [BI] among those for whom a BI is indicated).

Secondary Outcome Measures

Referral to Treatment
To examine the relative effectiveness of the Generalist condition v. the Specialist condition in terms of referral to specialty substance abuse treatment for those adolescents for whom such treatment is indicated.
Long term penetration of BI within the Generalist and Specialist models
To examine the long term relative effectiveness of the Generalist condition v. the Specialist condition in terms of penetration of brief intervention (proportion of patients receiving BI among those for whom a BI is indicated).
HIV sex-risk behavior screening as part of adolescent SBIRT process
To examine the feasibility and acceptability of integrating HIV risk behavior screening into adolescent primary care as part of an SBIRT program.

Full Information

First Posted
April 9, 2013
Last Updated
February 13, 2018
Sponsor
Friends Research Institute, Inc.
Collaborators
RTI International, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01829308
Brief Title
SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers
Acronym
ST@T
Official Title
SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
RTI International, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the implementation of two evidence-based intervention strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol, tobacco, other drug use, and HIV risk behaviors.
Detailed Description
Guided by Proctor's conceptual model of implementation research, the proposed study is a multi-site, cluster randomized trial to compare two principal strategies of SBIRT delivery within adolescent medicine. In the Generalist Strategy, the primary care provider delivers brief intervention (BI) for substance misuse. In the Specialist Strategy, BIs are delivered by behavioral health counselors. The 7 study sites, primary care clinics operated by a large, urban Federally Qualified Health Center in Baltimore, will be randomly assigned to implement SBIRT for adolescents using either the Generalist or Specialist strategies. Staff at each site will be trained in the assigned implementation strategy, and quarterly booster trainings will be provided during the implementation period. Implementation outcomes, including: penetration, costs/cost-effectiveness, acceptability, timeliness, fidelity/adherence, and patient satisfaction will be assessed during the 18-month-long implementation period using a complementary combination of administrative service encounter data, provider and patient surveys, and qualitative interviews. At the end of the active implementation period, all training and technical support activities will cease for 12 months in order to measure relative sustainability. The study will also examine the effectiveness of integrating HIV risk screening within an SBIRT model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-induced Disorders, Drug Users, Tobacco Use Disorder
Keywords
implementation, SBIRT, alcohol screening, drug screening, Brief Intervention, Referral to Treatment, adolescents, Federally Qualified Health Centers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specialist
Arm Type
Experimental
Arm Description
The brief interventions are delivered by behavioral health counselors.
Arm Title
Generalist
Arm Type
Active Comparator
Arm Description
The brief interventions are delivered by the primary care provider.
Intervention Type
Behavioral
Intervention Name(s)
The brief interventions are delivered by behavioral health counselors (Specialist)
Intervention Description
Behavioral Health Specialists perform the brief intervention. The screening and referral to treatment processes remain the same as with the Generalist condition.
Intervention Type
Behavioral
Intervention Name(s)
The brief interventions are delivered by the primary care provider (Generalist)
Intervention Description
Primary care providers perform the brief intervention. The screening and referral to treatment processes remain the same as with the Specialist condition.
Primary Outcome Measure Information:
Title
Penetration of BI within the Generalist and Specialist models
Description
To examine the relative effectiveness of the Generalist condition v. the Specialist condition in terms of penetration of brief intervention (proportion of patients receiving brief intervention [BI] among those for whom a BI is indicated).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Referral to Treatment
Description
To examine the relative effectiveness of the Generalist condition v. the Specialist condition in terms of referral to specialty substance abuse treatment for those adolescents for whom such treatment is indicated.
Time Frame
12 months
Title
Long term penetration of BI within the Generalist and Specialist models
Description
To examine the long term relative effectiveness of the Generalist condition v. the Specialist condition in terms of penetration of brief intervention (proportion of patients receiving BI among those for whom a BI is indicated).
Time Frame
12 months
Title
HIV sex-risk behavior screening as part of adolescent SBIRT process
Description
To examine the feasibility and acceptability of integrating HIV risk behavior screening into adolescent primary care as part of an SBIRT program.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: clinic staff Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon G Mitchell, PhD
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Total Health Care
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21217
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32087839
Citation
Mitchell SG, Gryczynski J, Schwartz RP, Kirk AS, Dusek K, Oros M, Hosler C, O'Grady KE, Brown BS. Adolescent SBIRT implementation: Generalist vs. Specialist models of service delivery in primary care. J Subst Abuse Treat. 2020 Apr;111:67-72. doi: 10.1016/j.jsat.2020.01.007. Epub 2020 Jan 20.
Results Reference
derived
PubMed Identifier
30850312
Citation
Monico LB, Mitchell SG, Dusek K, Gryczynski J, Schwartz RP, Oros M, Hosler C, O'Grady KE, Brown BS. A Comparison of Screening Practices for Adolescents in Primary Care After Implementation of Screening, Brief Intervention, and Referral to Treatment. J Adolesc Health. 2019 Jul;65(1):46-50. doi: 10.1016/j.jadohealth.2018.12.005. Epub 2019 Mar 6.
Results Reference
derived

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SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers

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