Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Treatment Research Institute
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
Treatment Research Institute
ClinicalTrials.gov Identifier:
NCT01751672
First received: December 5, 2012
Last updated: February 10, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751672

Contacts
Contact: Adam C Brooks, PhD 215-399-0980 abrooks@tresearch.org
Contact: Carolyn M Carpenedo, MHS 215-399-09880 ccarpenedo@tresearch.org

Locations
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
Sponsors and Collaborators
Treatment Research Institute
Pennsylvania Department of Health
Investigators
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: SAP No. 4100055578, 09-07-05
Study First Received: December 5, 2012
Last Updated: February 10, 2014
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 July 28, 2014