Integrating Substance Abuse Assessment & Intervention in Primary Care Settings
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Purpose
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 | Intervention |
|---|---|
|
Drug Use Alcohol Use |
Behavioral: SBIRT Behavioral: SBIRT+ |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Integrating Substance Abuse Assessment & Intervention in Primary Care Settings |
- Change in Treatment Session Attendance from Baseline [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]Treatment sessions attended for alcohol or drug use issues over time.
- Change in Urinalysis from Baseline [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]Urinalysis results for cocaine, marijuana, opiates, sedatives, and hallucinogens over time.
- Change in Cost-Effectiveness from Baseline [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]Cost-effectiveness of the interventions compared to standard care over time.
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Adam C Brooks, PhD | 215-399-0980 | abrooks@tresearch.org |
| Contact: Carolyn M Carpenedo, MHS | 215-399-09880 | ccarpenedo@tresearch.org |
| United States, Pennsylvania | |
| Public Health Management Corporation's Care Clinic | Recruiting |
| Philadelphia, Pennsylvania, United States, 19123 | |
| Eleventh Street Family Health Services of Drexel University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19123 | |
| Contact: Patricia Gerrity, RN, PhD 215-769-1105 | |
| Abbottsford-Falls Family Practice, Resources for Human Development, Inc. | Recruiting |
| Philadelphia, Pennsylvania, United States, 19144 | |
| Principal Investigator: | Adam C Brooks, PhD | Treatment Research Institute |
More Information
No publications provided
| Responsible Party: | Treatment Research Institute |
| ClinicalTrials.gov Identifier: | NCT01751672 History of Changes |
| Other Study ID Numbers: | 09-07-01, 09-07-05 |
| Study First Received: | December 5, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Treatment Research Institute:
|
SBIRT Substance Use Screening Brief Intervention Primary Care |
Additional relevant MeSH terms:
|
Alcohol Drinking Substance-Related Disorders Drinking Behavior Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013