Trial Outcomes & Findings for Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings (NCT NCT02893514)

NCT ID: NCT02893514

Last Updated: 2022-05-09

Results Overview

Reported by Patients

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2022-05-09

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	42	37
Overall Study COMPLETED	42	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings

Baseline characteristics by cohort

Measure	Screening Only (SO) n=42 Participants Screening Only (SO) condition: 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) n=37 Participants 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.	Total n=79 Participants Total of all reporting groups
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.7 years STANDARD_DEVIATION 13.8 • n=5 Participants	45.0 years STANDARD_DEVIATION 13.1 • n=7 Participants	45.4 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	4 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	33 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	37 participants n=7 Participants	79 participants n=5 Participants
Clinic Type Primary Care	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Clinic Type HIV	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Reported by Patients

Outcome measures

Measure	Screening Only (SO) n=42 Participants Screening Only (SO) condition: 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) n=37 Participants 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.
Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit	17 Participants	33 Participants

Adverse Events

Screening Only (SO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Substance Use Screening and Intervention Tool (SUSIT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer McNeely, MD, MS

NYU Langone Health

Phone: (646) 501-3551

Email: Jennifer.McNeely@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place