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Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings

Primary Purpose

Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening Only (SO) condition
SUSIT Condition
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Addiction focused on measuring Drug Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Substance use screening results (collected using the tablet-based screening tool) indicating current moderate risk drug use, based on a substance specific involvement score (SSIS) indicating current (past 3 months) use of at least one drug with a moderate risk level (SSIS 4-26), in the absence of any high-risk drug or alcohol use (SSIS 27+);
  • Presenting for visit with a participating PCP

Exclusion Criteria:

  • Prior participation in the study (i.e. participation in the SO study phase would preclude participation in the SUSIT phase);
  • Attending a formal addiction treatment program (not including informal treatment such as Alcoholics Anonymous, Narcotics Anonymous), in the past 3 months;
  • Pregnant (based on self-report).

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Screening Only (SO)

Substance Use Screening and Intervention Tool (SUSIT)

Arm Description

Outcomes

Primary Outcome Measures

Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit
Reported by Patients

Secondary Outcome Measures

Full Information

First Posted
August 11, 2016
Last Updated
April 13, 2022
Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02893514
Brief Title
Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings
Official Title
Leveraging Technology to Address Unhealthy Drug Use in Primary Care: Effectiveness of the Substance Use Screening and Intervention Tool (SUSIT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will develop a clinical decision support tool that assists primary care providers in carrying out substance use interventions, and then compare (in Phase 2) two clinical scenarios, screening only (SO) vs. SUSIT, (on dose of substance use brief intervention received) and changes in drug use at 3 and 6 months, among primary care patients. Investigators will develop the Clinical Decision Support (CDS) component and then test the full SUSIT approach, using mixed methods to assess its acceptability and adoption, and gathering preliminary data on its efficacy for reducing unhealthy drug use. CDS development is concurrent with the SO phase to avoid losing valuable time, but will be conducted at a secondary study site to avoid contaminating the SO condition.
Detailed Description
This study has 3 specific aims: Aim 1 is to develop clinical decision support that assists primary care providers in carrying out a brief intervention. Aim 2 is to assess the impact of the SUSIT on dose of substance use brief intervention received by patients. Aim 3 is to gather preliminary evidence on the efficacy of the SUSIT approach for reducing moderate-risk drug use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction
Keywords
Drug Use

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening Only (SO)
Arm Type
Placebo Comparator
Arm Title
Substance Use Screening and Intervention Tool (SUSIT)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Screening Only (SO) condition
Intervention Description
Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.
Intervention Type
Other
Intervention Name(s)
SUSIT Condition
Intervention Description
Following completion of substance use screening, the tablet computer presents screening results (including level of risk) to the patient for each substance used, asks them to identify their drug of most concern (DOMC), and assesses readiness and confidence to change behavior. Results are delivered to the PCP at the point of care, paired with clinical decision support tailored to the patient's screening results. This information is delivered on the tablet computer, which is handed to the PCP by a Medical Assistant. CDS guides the PCP through a brief intervention specific to the DOMC, recommends clinical actions pertaining to the substance and risk level, and generates a printed summary for the patient. At each scheduled follow-up medical visit, the PCP receives a clinical reminder containing a summary of the patient's substance use and level of risk, paired with CDS that guides them through a follow-up brief intervention.
Primary Outcome Measure Information:
Title
Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit
Description
Reported by Patients
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Substance use screening results (collected using the tablet-based screening tool) indicating current moderate risk drug use, based on a substance specific involvement score (SSIS) indicating current (past 3 months) use of at least one drug with a moderate risk level (SSIS 4-26), in the absence of any high-risk drug or alcohol use (SSIS 27+); Presenting for visit with a participating PCP Exclusion Criteria: Prior participation in the study (i.e. participation in the SO study phase would preclude participation in the SUSIT phase); Attending a formal addiction treatment program (not including informal treatment such as Alcoholics Anonymous, Narcotics Anonymous), in the past 3 months; Pregnant (based on self-report).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer McNeely, MD, MS
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings

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