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

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

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
Age, Continuous
45.7 years
STANDARD_DEVIATION 13.8 • n=99 Participants
45.0 years
STANDARD_DEVIATION 13.1 • n=107 Participants
45.4 years
STANDARD_DEVIATION 13.4 • n=206 Participants
Sex: Female, Male
Female
15 Participants
n=99 Participants
4 Participants
n=107 Participants
19 Participants
n=206 Participants
Sex: Female, Male
Male
27 Participants
n=99 Participants
33 Participants
n=107 Participants
60 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants
n=99 Participants
13 Participants
n=107 Participants
28 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants
n=99 Participants
23 Participants
n=107 Participants
46 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=99 Participants
1 Participants
n=107 Participants
5 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
15 Participants
n=99 Participants
12 Participants
n=107 Participants
27 Participants
n=206 Participants
Race (NIH/OMB)
White
10 Participants
n=99 Participants
9 Participants
n=107 Participants
19 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
15 Participants
n=99 Participants
13 Participants
n=107 Participants
28 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
Region of Enrollment
United States
42 participants
n=99 Participants
37 participants
n=107 Participants
79 participants
n=206 Participants
Clinic Type
Primary Care
20 Participants
n=99 Participants
11 Participants
n=107 Participants
31 Participants
n=206 Participants
Clinic Type
HIV
22 Participants
n=99 Participants
26 Participants
n=107 Participants
48 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Baseline

Reported by Patients

Outcome measures

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

Results disclosure agreements

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