Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

NCT ID: NCT01751672

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Drug Use; Alcohol Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBIRT

Screening, Brief Intervention, and Referral to Treatment

Group Type: ACTIVE_COMPARATOR

SBIRT

Intervention Type: BEHAVIORAL

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

SBIRT+

Expanded Screening, Brief Intervention, and Referral to Treatment

Group Type: EXPERIMENTAL

SBIRT+

Intervention Type: BEHAVIORAL

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

Interventions

SBIRT

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

Intervention Type: BEHAVIORAL

SBIRT+

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role: collaborator

Treatment Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam C Brooks, PhD

Role: PRINCIPAL_INVESTIGATOR

Treatment Research Institute

Locations

Eleventh Street Family Health Services of Drexel University

Philadelphia, Pennsylvania, United States

Public Health Management Corporation's Care Clinic

Philadelphia, Pennsylvania, United States

Abbottsford-Falls Family Practice, Resources for Human Development, Inc.

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27090097 (View on PubMed)

Other Identifiers

09-07-05

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SAP No. 4100055578

Identifier Type: -

Identifier Source: org_study_id