Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings

Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893514
• Other study ID #: 16-01074
• Secondary ID: 1R34DA040830-01
• Status: Completed
• Phase: N/A
• Start date: April 13, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: April 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 31, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit	Reported by Patients	Baseline