Addiction
Conditions
Keywords
Drug Use
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.
Interventions
OTHERScreening Only (SO) condition
Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.
OTHERSUSIT 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.
Sponsors
National Institute on Drug Abuse (NIDA)
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit | Baseline | Reported by Patients |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Screening Only (SO) Screening Only (SO) condition: Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders. | 42 |
| Substance Use Screening and Intervention Tool (SUSIT) 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. | 37 |
| Total | 79 |
Baseline characteristics
| Characteristic | Screening Only (SO) | Substance Use Screening and Intervention Tool (SUSIT) | Total |
|---|---|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 13.8 | 45.0 years STANDARD_DEVIATION 13.1 | 45.4 years STANDARD_DEVIATION 13.4 |
| Clinic Type HIV | 22 Participants | 26 Participants | 48 Participants |
| Clinic Type Primary Care | 20 Participants | 11 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 13 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 23 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 12 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 13 Participants | 28 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 10 Participants | 9 Participants | 19 Participants |
| Region of Enrollment United States | 42 participants | 37 participants | 79 participants |
| Sex: Female, Male Female | 15 Participants | 4 Participants | 19 Participants |
| Sex: Female, Male Male | 27 Participants | 33 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 37 |
| other Total, other adverse events | 0 / 42 | 0 / 37 |
| serious Total, serious adverse events | 0 / 42 | 0 / 37 |
Outcome results
Primary
Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit
Reported by Patients
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening Only (SO) | Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit | 17 Participants |
| Substance Use Screening and Intervention Tool (SUSIT) | Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit | 33 Participants |