Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings

NCT02893514 | Completed Results

• 2 other identifiers: 16-010741R34DA040830-01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Addiction

Keywords

Drug Use

Outcome Measures

Primary Outcomes (1)

• Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit

  Reported by Patients

  Baseline

Study Arms (2)

Screening Only (SO)

PLACEBO COMPARATOR

Other: Screening Only (SO) condition

Substance Use Screening and Intervention Tool (SUSIT)

EXPERIMENTAL

Other: SUSIT Condition

Interventions

Screening Only (SO) condition OTHER

Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.

Screening Only (SO)

SUSIT Condition OTHER

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.

Substance Use Screening and Intervention Tool (SUSIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Results Point of Contact

• Title: Jennifer McNeely, MD, MS
• Organization: NYU Langone Health

Jennifer.McNeely@nyulangone.org

(646) 501-3551

Study Officials

• Jennifer McNeely, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 8, 2016
• Study Start: April 13, 2017
• Primary Completion: March 30, 2019
• Study Completion: July 31, 2019
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-04

Locations

US (1)