Clinical Trial: SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Friends Research Institute, Inc.

Current Primary Outcome: Penetration of BI within the Generalist and Specialist models [ Time Frame: 12 months ]

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).


Original Primary Outcome: Penetration of BI within the Generalist and Specialist models [ Time Frame: 6 months ]

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).


Current Secondary Outcome:

  • Referral to Treatment [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]
    To examine the feasibility and acceptability of integrating HIV risk behavior screening into adolescent primary care as part of an SBIRT program.


Original Secondary Outcome: Same as current

Information By: Friends Research Institute, Inc.

Dates:
Date Received: April 9, 2013
Date Started: April 2013
Date Completion: June 2017
Last Updated: September 29, 2016
Last Verified: September 2016