SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers

Tobacco Use Disorder Clinical Trial

— ST@T  

Official title:

SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829308
• Other study ID #: 1R01DA034258-01
• Secondary ID: 1R01DA034258-01
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: February 13, 2018
• Start date: April 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• clinic staff

Exclusion Criteria:

Related Conditions & MeSH terms

• Alcohol-induced Disorders
• Disease
• Drug Users
• Tobacco Use Disorder

Intervention

Behavioral:
• The brief interventions are delivered by behavioral health counselors (Specialist)
Behavioral Health Specialists perform the brief intervention. The screening and referral to treatment processes remain the same as with the Generalist condition.
• The brief interventions are delivered by the primary care provider (Generalist)
Primary care providers perform the brief intervention. The screening and referral to treatment processes remain the same as with the Specialist condition.

Locations

Country	Name	City	State
United States	Total Health Care	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	National Institute on Drug Abuse (NIDA), RTI International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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