Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings

NCT ID: NCT02893514

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-13
• Study Completion Date: 2019-07-31

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.

Conditions

Addiction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Screening Only (SO)

Group Type: PLACEBO_COMPARATOR

Screening Only (SO) condition

Intervention Type: OTHER

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

Substance Use Screening and Intervention Tool (SUSIT)

Group Type: EXPERIMENTAL

SUSIT Condition

Intervention Type: 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.

Interventions

Screening Only (SO) condition

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

Intervention Type: 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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer McNeely, MD, MS

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R34DA040830-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-01074

Identifier Type: -

Identifier Source: org_study_id