Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

Conditions
-----------------
Drug Use, Alcohol Use

Intervention / Treatment
-----------------
* Behavioral: SBIRT
* Behavioral: SBIRT+


Participation Criteria
=================
Eligibility Criteria
-----------------
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

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

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SBIRT, Substance Use, Screening, Brief Intervention, Primary Care