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Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01751672
Enrollment
600
Registered
2012-12-18
Start date
2012-06-30
Completion date
2015-05-31
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use, Drug Use

Keywords

SBIRT, Substance Use, Screening, Brief Intervention, Primary Care

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.

Interventions

BEHAVIORALSBIRT

Screening, Brief Intervention, and Referral to Treatment. Standard, single session SBIRT.

BEHAVIORALSBIRT+

Expanded Screening, Brief Intervention, and Referral to Treatment. One Standard SBIRT session, plus 2-6 additional Brief Intervention sessions as needed.

Sponsors

Pennsylvania Department of Health
CollaboratorOTHER_GOV
Treatment Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Treatment Session Attendance from Baseline0, 3, 6, 9, 12 monthsTreatment sessions attended for alcohol or drug use issues over time.

Secondary

MeasureTime frameDescription
Change in Urinalysis from Baseline0, 3, 6, 9, 12 monthsUrinalysis results for cocaine, marijuana, opiates, sedatives, and hallucinogens over time.
Change in Cost-Effectiveness from Baseline0, 3, 6, 9, 12 monthsCost-effectiveness of the interventions compared to standard care over time.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026