AddictionNCT02893514
Leveraging Technology to Address Unhealthy Drug Use in Primary Care Settings
A study testing Screening Only (SO) condition and SUSIT Condition in people with Addiction, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Addiction
- What is being tested?
- Screening Only (SO) condition and SUSIT Condition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Leveraging Technology to Address Unhealthy Drug Use in Primary Care: Effectiveness of the Substance Use Screening and Intervention Tool (SUSIT)
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.
Read the 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
- Being tested
- Screening Only (SO) condition, SUSIT Condition
- Keywords
- Drug Use
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening Only (SO) conditionOther
Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.
SUSIT ConditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening Only (SO) | Placebo comparator | Not described Receives: Other: Screening Only (SO) condition |
| Substance Use Screening and Intervention Tool (SUSIT) | Experimental | Not described Receives: Other: SUSIT Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit
Reported by Patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start13 Apr 2017
- Primary completion30 Mar 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jennifer McNeely, MD, MS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893514
- Sponsor's protocol ID
- 16-01074
- Other IDs
- 1R34DA040830-01
- Status last verified
- Apr 2022
- First submitted
- 11 Aug 2016
- Last updated
- 9 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Technology to Address Unhealthy Drug Use in Primary Care: Effectiveness of the Substance Use Screening and Intervention Tool (SUSIT)
- ClinicalTrials.gov ID
- NCT02893514
- Acronym / sponsor ID
- 16-01074
- Conditions
- Addiction
- Keywords
- Drug Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 9 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening Only (SO) | Placebo comparator | Other: Screening Only (SO) condition |
| Substance Use Screening and Intervention Tool (SUSIT) | Experimental | Other: SUSIT Condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening Only (SO) conditionPatient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders. | Other | Screening Only (SO) |
| SUSIT ConditionFollowing 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. | Other | Substance Use Screening and Intervention Tool (SUSIT) |
Primary outcome
Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit
Time frame: Baseline
Reported by Patients
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer McNeely, MD, MS principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening Only (SO) condition and SUSIT Condition in people with Addiction, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of Brief Intervention (BI) for Drug Use at Baseline Visit (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.