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Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

Primary Purpose

Drug Use, Alcohol Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBIRT
SBIRT+
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Use focused on measuring SBIRT, Substance Use, Screening, Brief Intervention, Primary Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eleventh Street Family Health Services of Drexel University
  • Public Health Management Corporation's Care Clinic
  • Abbottsford-Falls Family Practice, Resources for Human Development, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SBIRT

SBIRT+

Arm Description

Screening, Brief Intervention, and Referral to Treatment

Expanded Screening, Brief Intervention, and Referral to Treatment

Outcomes

Primary Outcome Measures

Change in Treatment Session Attendance from Baseline
Treatment sessions attended for alcohol or drug use issues over time.

Secondary Outcome Measures

Change in Urinalysis from Baseline
Urinalysis results for cocaine, marijuana, opiates, sedatives, and hallucinogens over time.
Change in Cost-Effectiveness from Baseline
Cost-effectiveness of the interventions compared to standard care over time.

Full Information

First Posted
December 5, 2012
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
Collaborators
Pennsylvania Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT01751672
Brief Title
Integrating Substance Abuse Assessment & Intervention in Primary Care Settings
Official Title
Integrating Substance Abuse Assessment & Intervention in Primary Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute
Collaborators
Pennsylvania Department of Health

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use, Alcohol Use
Keywords
SBIRT, Substance Use, Screening, Brief Intervention, Primary Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBIRT
Arm Type
Active Comparator
Arm Description
Screening, Brief Intervention, and Referral to Treatment
Arm Title
SBIRT+
Arm Type
Experimental
Arm Description
Expanded Screening, Brief Intervention, and Referral to Treatment
Intervention Type
Behavioral
Intervention Name(s)
SBIRT
Intervention Description
Screening, Brief Intervention, and Referral to Treatment. Standard, single session SBIRT.
Intervention Type
Behavioral
Intervention Name(s)
SBIRT+
Intervention Description
Expanded Screening, Brief Intervention, and Referral to Treatment. One Standard SBIRT session, plus 2-6 additional Brief Intervention sessions as needed.
Primary Outcome Measure Information:
Title
Change in Treatment Session Attendance from Baseline
Description
Treatment sessions attended for alcohol or drug use issues over time.
Time Frame
0, 3, 6, 9, 12 months
Secondary Outcome Measure Information:
Title
Change in Urinalysis from Baseline
Description
Urinalysis results for cocaine, marijuana, opiates, sedatives, and hallucinogens over time.
Time Frame
0, 3, 6, 9, 12 months
Title
Change in Cost-Effectiveness from Baseline
Description
Cost-effectiveness of the interventions compared to standard care over time.
Time Frame
0, 3, 6, 9, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam C Brooks, PhD
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eleventh Street Family Health Services of Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19123
Country
United States
Facility Name
Public Health Management Corporation's Care Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19123
Country
United States
Facility Name
Abbottsford-Falls Family Practice, Resources for Human Development, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19144
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27090097
Citation
Chambers JE, Brooks AC, Medvin R, Metzger DS, Lauby J, Carpenedo CM, Favor KE, Kirby KC. Examining multi-session brief intervention for substance use in primary care: research methods of a randomized controlled trial. Addict Sci Clin Pract. 2016 Apr 18;11(1):8. doi: 10.1186/s13722-016-0057-6.
Results Reference
derived

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Integrating Substance Abuse Assessment & Intervention in Primary Care Settings

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