Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

Sponsor

Treatment Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01751672

Collaborator

Pennsylvania Department of Health (Other)

600

Enrollment

Locations

Arms

Duration (Months)

200

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Use Alcohol Use	Behavioral: SBIRT Behavioral: SBIRT+	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: SBIRT

Screening, Brief Intervention, and Referral to Treatment

Behavioral: SBIRT

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

Experimental: SBIRT+

Expanded Screening, Brief Intervention, and Referral to Treatment

Behavioral: SBIRT+

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

Outcome Measures

Primary Outcome Measures

Change in Treatment Session Attendance from Baseline [0, 3, 6, 9, 12 months]
Treatment sessions attended for alcohol or drug use issues over time.

Secondary Outcome Measures

Change in Urinalysis from Baseline [0, 3, 6, 9, 12 months]
Urinalysis results for cocaine, marijuana, opiates, sedatives, and hallucinogens over time.
Change in Cost-Effectiveness from Baseline [0, 3, 6, 9, 12 months]
Cost-effectiveness of the interventions compared to standard care over time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eleventh Street Family Health Services of Drexel University	Philadelphia	Pennsylvania	United States	19123
2	Public Health Management Corporation's Care Clinic	Philadelphia	Pennsylvania	United States	19123
3	Abbottsford-Falls Family Practice, Resources for Human Development, Inc.	Philadelphia	Pennsylvania	United States	19144