Clinical trial NCT01751672: Integrating Substance Abuse Assessment & Intervention in Primary Care Settings
Official title: Integrating Substance Abuse Assessment & Intervention in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use
Alcohol Use
Keywords: SBIRT
Substance Use
Screening
Brief Intervention
Primary Care
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
First posted: 2012-12-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Treatment Session Attendance from Baseline
timeFrame: 0, 3, 6, 9, 12 months
Secondary outcomes:
measure: Change in Urinalysis from Baseline
timeFrame: 0, 3, 6, 9, 12 months
measure: Change in Cost-Effectiveness from Baseline
timeFrame: 0, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Eleventh Street Family Health Services of Drexel University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Public Health Management Corporation's Care Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abbottsford-Falls Family Practice, Resources for Human Development, Inc.
state: Pennsylvania
Study officials:
affiliation: Treatment Research Institute
name: Adam C Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.