Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings

Leveraging Technology to Address Unhealthy Drug Use in Primary Care: Effectiveness of the Substance Use Screening and Intervention Tool (SUSIT)

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.

Study Overview

• Status: Completed
• Conditions: Addiction
• Intervention / Treatment: Other: Screening Only (SO) condition; Other: SUSIT 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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Screening Only (SO)	Other: Screening Only (SO) condition; Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.
Experimental: Substance Use Screening and Intervention Tool (SUSIT)	Other: SUSIT Condition; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit	Reported by Patients	Baseline

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jennifer McNeely, MD, MS, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Drug Use
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID Numbers: 16-01074; 1R34DA040830-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No