SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers

Study Overview
=================
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.

Official Title
-----------------
SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers

Conditions
-----------------
Alcohol-induced Disorders, Drug Users, Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: The brief interventions are delivered by behavioral health counselors (Specialist)
* Behavioral: The brief interventions are delivered by the primary care provider (Generalist)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinic staff Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specialist<br>The brief interventions are delivered by behavioral health counselors. | Behavioral: The brief interventions are delivered by behavioral health counselors (Specialist)<br>* Behavioral Health Specialists perform the brief intervention. The screening and referral to treatment processes remain the same as with the Generalist condition.<br>|
| Active Comparator: Generalist<br>The brief interventions are delivered by the primary care provider. | Behavioral: The brief interventions are delivered by the primary care provider (Generalist)<br>* Primary care providers perform the brief intervention. The screening and referral to treatment processes remain the same as with the Specialist condition.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| 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). | 12 months | 
| 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. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
implementation, SBIRT, alcohol screening, drug screening, Brief Intervention, Referral to Treatment, adolescents, Federally Qualified Health Centers