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OpenTrials
Completed

NCT Number: NCT01751672

Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbottsford-Falls Family Practice, Resources for Human Development, Inc., Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBIRT

Behavioral

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

SBIRT+

Behavioral

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

Primary outcomes

  1. Change in Treatment Session Attendance from Baseline

    Time frame: 0, 3, 6, 9, 12 months

    Treatment sessions attended for alcohol or drug use issues over time.

Secondary outcomes

  1. Change in Urinalysis from Baseline

    Time frame: 0, 3, 6, 9, 12 months

    Urinalysis results for cocaine, marijuana, opiates, sedatives, and hallucinogens over time.

  2. Change in Cost-Effectiveness from Baseline

    Time frame: 0, 3, 6, 9, 12 months

    Cost-effectiveness of the interventions compared to standard care over time.

Sponsors and collaborators

Lead sponsor

Treatment Research Institute

Other

Collaborators

  • Pennsylvania Department of Health

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 18, 2012
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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