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Data-driven Identification for Substance Misuse

Data-driven Strategies for Substance Misuse Identification in Hospitalized Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03833804
Enrollment
64996
Registered
2019-02-07
Start date
2022-09-19
Completion date
2024-09-19
Last updated
2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Abuse, Substance-Related Disorders, Substance Use

Keywords

natural language processing, machine learning, artificial intelligence, clinical decision support, unhealthy alcohol use, opioid use disorder, illicit drug use

Brief summary

The investigators propose to develop an open-source, publicly available machine learning model that health systems could download and apply to their electronic health record data marts to screen for substance misuse in their patients. The investigators hypothesize that the natural language processing algorithm can provide a standardized and interoperable approach for an automated daily screen on all hospitalized patients and provide better implementation fidelity for screening, brief intervention, and referral to treatment.

Detailed description

In 2016, nearly 30% hospital discharges in the United States (US) had a major diagnostic category for a substance-use related condition. Substance misuse ranks second among principal diagnoses for unplanned 7-day hospital readmission rates. Despite the availability of Screening, Brief Intervention, and Referral to Treatment (SBIRT) interventions, substance misuse is not part of the admission routine and only a minority of patients are screened for substance misuse in the hospital setting. This is particularly problematic, since among hospitalized inpatients, the prevalence of substance misuse is estimated to be as high as 25%, greater than either the general population or outpatient setting. Practical screening methods tailored for the hospital setting are needed. In the advent of Meaningful Use in the electronic health record (EHR), efficiency for alcohol detection may be improved by leveraging data collected during usual care. Documentation of substance use is common and occurs in over 96% of provider admission notes, but their free text format renders them difficult to mine and analyze. Natural Language Processing (NLP) and machine learning are subfields of artificial intelligence (AI) that provide a solution to analyze text data in the EHR to identify substance misuse. Modern NLP has fused with machine learning, another sub-field of artificial intelligence focused on learning from data. In particular, the most powerful NLP methods rely on supervised learning, a type of machine learning that takes advantage of current reference standards to make predictions about unseen cases In the earlier version of an NLP and machine learning tool, the investigators successfully used data from clinical notes collected in the first 24 hours of hospital admission to reach a sensitivity and specificity above 70% for identifying alcohol misuse. With nearly 36 million hospital admissions in 2016, a substance misuse classifier has potential to impact millions. In this study, the aim is to prospectively implement a substance misuse classifier to examine its effectiveness against current practice of all hospitalized adult patients at a tertiary health system. The health system has a mature screening system to examine substance misuse classifier performance against current practice of questionnaire screening. The hypothesis is that the substance misuse classifier may provide a standardized, interoperable, and accurate approach to screen hospitalized patients. Successful implementation of the classifier in hospitalized patients is a step towards an automated and comprehensive universal screening system for substance misuse.

Interventions

OTHERProcessing of clinical notes in the EHR data collected during routine care

Clinical notes collected in the first day of hospital admission during usual care as input to natural language processing and machine learning algorithm.

Sponsors

Rush University Medical Center
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE

Masking description

No masking as the manual screen is already part of usual care and the automated screen will become usual care in the post-period of the pre-post design.

Intervention model description

Quasi-experimental design as an interrupted time series

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* Ages 18 years old to 89 years old * Inpatient status during hospitalization * Length of stay greater than 24 hours

Exclusion criteria

* Cannot participate in the usual care SBIRT intervention * Death or obtunded during first 24 hours of admission * Discharged against medical advice * Transferred from another acute care hospital * Transferred to another acute care hospital

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients That Had a Universal Screen Positive and Received SBIRT (Screening, Brief Intervention, or Referral to Treatment)24 monthsThe primary outcome is the proportion of patients who received SBIRT after a positive universal screen for being at risk for substance misuse. The design is an interrupted time-series prospective observational study.

Secondary

MeasureTime frameDescription
All-cause Re-hospitalizations Following 6-months From the Index Hospital Encounter12 months enrollment with 6 months follow-up for rehospitalizationWe will compare healthcare utilization outcomes in all patients between pre- and post-periods controlling for all patient demographic and clinical characteristics.

Countries

United States

Participant flow

Pre-assignment details

The comparison groups are pre-intervention and intervention. data from 31432 people were assessed prior to the intervention in 2022-2023 and data from 33564 people were assessed with the intervention from 2023-2024: data from 64996 people were assessed in total.

Participants by arm

ArmCount
Usual Care
Before intervention
31,432
NLP (Natural Language Processing) Pre-screen: SMART-AI
Automated processing of clinical notes collected during routine care in first 24 hours of hospital admission to identify individuals at-risk for substance misuse to receive standard-of-care full screening and assessment, brief intervention, or referral to treatment (SBIRT) intervention. Processing of clinical notes in the EHR data collected during routine care: Clinical notes collected in the first day of hospital admission during usual care as input to natural language processing and machine learning algorithm.
33,564
Total64,996

Baseline characteristics

CharacteristicTotalNLP (Natural Language Processing) Pre-screen: SMART-AIUsual Care
Admission Type
Elective
28405 Participants14652 Participants13753 Participants
Admission Type
Emergency
36591 Participants18912 Participants17679 Participants
Age, Continuous56 years
STANDARD_DEVIATION 19
56 years
STANDARD_DEVIATION 19
56 years
STANDARD_DEVIATION 19
Discharge
AMA
797 Participants385 Participants412 Participants
Discharge
Home
44511 Participants23335 Participants21176 Participants
Discharge
Home / Home Health
11267 Participants5528 Participants5739 Participants
Discharge
Hospice / Expired
1932 Participants1004 Participants928 Participants
Discharge
Long Term Acute Care
336 Participants171 Participants165 Participants
Discharge
Other Transfer
260 Participants162 Participants98 Participants
Discharge
Other / Unknown
124 Participants74 Participants50 Participants
Discharge
Psych
197 Participants93 Participants104 Participants
Discharge
Skilled Nursing Facility / Rehab
5572 Participants2812 Participants2760 Participants
Elixhauser Comorbidity2.9 comorbidities
STANDARD_DEVIATION 4.8
2.9 comorbidities
STANDARD_DEVIATION 4.9
2.8 comorbidities
STANDARD_DEVIATION 4.8
Insurance
Medicaid
17442 Participants8714 Participants8728 Participants
Insurance
Medicare
27475 Participants14364 Participants13111 Participants
Insurance
Other
390 Participants186 Participants204 Participants
Insurance
Private
15476 Participants8038 Participants7438 Participants
Insurance
Self Pay
1097 Participants666 Participants431 Participants
Insurance
Unknown
3116 Participants1596 Participants1520 Participants
Length of Stay (LOS)5.0 days
STANDARD_DEVIATION 6.5
4.9 days
STANDARD_DEVIATION 6.4
5.1 days
STANDARD_DEVIATION 6.5
Patient Class
Inpatient
50223 Participants25992 Participants24231 Participants
Patient Class
Observation
14773 Participants7572 Participants7201 Participants
Race/Ethnicity, Customized
Asian
2111 Participants1064 Participants1047 Participants
Race/Ethnicity, Customized
Black
22789 Participants11650 Participants11139 Participants
Race/Ethnicity, Customized
Hispanic
15424 Participants8061 Participants7363 Participants
Race/Ethnicity, Customized
Other
2376 Participants1318 Participants1058 Participants
Race/Ethnicity, Customized
Unknown
675 Participants374 Participants301 Participants
Race/Ethnicity, Customized
White
21621 Participants11097 Participants10524 Participants
Region of Enrollment
United States
64996 participants33564 participants31432 participants
Sex: Female, Male
Female
37879 Participants19421 Participants18458 Participants
Sex: Female, Male
Male
27117 Participants14143 Participants12974 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Proportion of Patients That Had a Universal Screen Positive and Received SBIRT (Screening, Brief Intervention, or Referral to Treatment)

The primary outcome is the proportion of patients who received SBIRT after a positive universal screen for being at risk for substance misuse. The design is an interrupted time-series prospective observational study.

Time frame: 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareProportion of Patients That Had a Universal Screen Positive and Received SBIRT (Screening, Brief Intervention, or Referral to Treatment)1189 Participants
SMART-AIProportion of Patients That Had a Universal Screen Positive and Received SBIRT (Screening, Brief Intervention, or Referral to Treatment)1144 Participants
p-value: 0.2One-sided independent samples z-test
Secondary

All-cause Re-hospitalizations Following 6-months From the Index Hospital Encounter

We will compare healthcare utilization outcomes in all patients between pre- and post-periods controlling for all patient demographic and clinical characteristics.

Time frame: 12 months enrollment with 6 months follow-up for rehospitalization

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareAll-cause Re-hospitalizations Following 6-months From the Index Hospital Encounter9584 Participants
SMART-AIAll-cause Re-hospitalizations Following 6-months From the Index Hospital Encounter10241 Participants

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026