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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03833804
Other study ID # 2021-0509
Secondary ID A534285SMPH/MEDI
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date March 30, 2025

Study information

Verified date January 2024
Source University of Wisconsin, Madison
Contact Majid Afshar, MD
Phone 3125459462
Email majid.afshar@wisc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 34800
Est. completion date March 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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

Study Design


Intervention

Other:
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.

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Afshar M, Phillips A, Karnik N, Mueller J, To D, Gonzalez R, Price R, Cooper R, Joyce C, Dligach D. Natural language processing and machine learning to identify alcohol misuse from the electronic health record in trauma patients: development and internal — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. 54 months
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. 12 months enrollment with 6 months follow-up for rehospitalization
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