Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

The purposes of this study are to: 1) implement a high fidelity Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol with computerized screening technology into three primary care clinics in urban Philadelphia; 2) conduct a randomized controlled trial to determine if an expanded SBIRT (SBIRT+) will help patients attend more specialty substance abuse treatment sessions and reduce substance use compared to SBIRT; 3) conduct a process evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and structured interviews to assess implementation barriers and workforce attitudinal shifts; and 4) provide an excellent clinical research training environment for undergraduate and graduate students from Lincoln University.

Study Overview

• Status: Completed
• Conditions: Alcohol Use; Drug Use
• Intervention / Treatment: Behavioral: SBIRT; Behavioral: SBIRT+

Detailed Description

This project has several specific aims. First, investigators plan to implement a high fidelity Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol with computerized screening technology into three primary care clinics in urban Philadelphia, and to train three Behavioral Health Consultants (BHCs) in an expanded brief intervention protocol (SBIRT+). Second, investigators will conduct a randomized controlled trial to address the following hypotheses: 1) patients assigned to SBIRT+ will attend more specialty substance abuse intervention and treatment sessions (excluding SBIRT+ sessions) over the 12 month follow-up than patients assigned to SBIRT; 2) patients assigned to SBIRT+ will demonstrate larger reductions in drug use by point prevalence urine samples and by reported days using over the 12-month follow-up compared to patients in SBIRT; 3) SBIRT+ will have positive net social benefits relative to SBIRT alone (i.e., will be cost-effective); 4) patients assigned to SBIRT+ will demonstrate improved medical, employment, legal, and psychiatric functioning, as well as reduced HIV risk over the 12-month follow-up compared to patients in SBIRT. Thirdly, investigators will also determine whether SBIRT and SBIRT+ are sustainable in primary care clinics as research funding for behavioral health consultants is phased out in Year 4 of the project. Investigators will also conduct a process evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and structured interviews to assess implementation barriers and workforce attitudinal shifts. This will inform methods to further disseminate SBIRT or SBIRT+, should the trial prove it is sustainable and cost-effective. Finally, investigators will provide an excellent clinical research training environment for undergraduate and graduate students from Lincoln University; this experience will balance hands-on clinical data collection and didactic training.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19123
      • Eleventh Street Family Health Services of Drexel University
    • Philadelphia, Pennsylvania, United States, 19123
      • Public Health Management Corporation's Care Clinic
    • Philadelphia, Pennsylvania, United States, 19144
      • Abbottsford-Falls Family Practice, Resources for Human Development, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient is 18 years or older
• Alcohol and/or Drug screening score that indicates at least mild problem severity.

Exclusion Criteria:

• medical or psychiatric complications
• substance use is mild enough that further intervention is not warranted
• patient reports plans to leave the area within the next 12 months
• patient is unable to provide valid informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SBIRT; Screening, Brief Intervention, and Referral to Treatment	Behavioral: SBIRT; Screening, Brief Intervention, and Referral to Treatment. Standard, single session SBIRT.
Experimental: SBIRT+; Expanded Screening, Brief Intervention, and Referral to Treatment	Behavioral: SBIRT+; Expanded Screening, Brief Intervention, and Referral to Treatment. One Standard SBIRT session, plus 2-6 additional Brief Intervention sessions as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Treatment Session Attendance from Baseline	Treatment sessions attended for alcohol or drug use issues over time.	0, 3, 6, 9, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Urinalysis from Baseline	Urinalysis results for cocaine, marijuana, opiates, sedatives, and hallucinogens over time.	0, 3, 6, 9, 12 months
Change in Cost-Effectiveness from Baseline	Cost-effectiveness of the interventions compared to standard care over time.	0, 3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: Treatment Research Institute
• Collaborators: Pennsylvania Department of Health
• Investigators: Principal Investigator: Adam C Brooks, PhD, Treatment Research Institute

Publications and helpful links

General Publications

• Chambers JE, Brooks AC, Medvin R, Metzger DS, Lauby J, Carpenedo CM, Favor KE, Kirby KC. Examining multi-session brief intervention for substance use in primary care: research methods of a randomized controlled trial. Addict Sci Clin Pract. 2016 Apr 18;11(1):8. doi: 10.1186/s13722-016-0057-6.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 18, 2012

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Primary Care; Screening; Substance Use; Brief Intervention; SBIRT
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: SAP No. 4100055578; 09-07-05 (Other Grant/Funding Number: PA DOH)