Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

Drug Use Clinical Trial

Official title:

Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751672
• Other study ID #: SAP No. 4100055578
• Secondary ID: 09-07-05
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: March 2023
• Source: Public Health Management Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use
• Drug Use
• Substance-Related Disorders

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Treatment Research Institute	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

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