Data-driven Identification for Substance Misuse
Primary Purpose
Substance Use, Substance Abuse, Substance-Related Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Processing of clinical notes in the EHR data collected during routine care
Sponsored by
About this trial
This is an interventional screening trial for Substance Use focused on measuring natural language processing, machine learning, artificial intelligence, clinical decision support, unhealthy alcohol use, opioid use disorder, illicit drug use
Eligibility Criteria
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
Sites / Locations
- Rush University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NLP (natural language processing) pre-screen
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03833804
First Posted
February 6, 2019
Last Updated
February 27, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03833804
Brief Title
Data-driven Identification for Substance Misuse
Official Title
Data-driven Strategies for Substance Misuse Identification in Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Substance Abuse, Substance-Related Disorders
Keywords
natural language processing, machine learning, artificial intelligence, clinical decision support, unhealthy alcohol use, opioid use disorder, illicit drug use
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi-experimental design as an interrupted time series
Masking
None (Open Label)
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.
Allocation
N/A
Enrollment
34800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NLP (natural language processing) pre-screen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Processing of clinical notes in the EHR data collected during routine care
Intervention Description
Clinical notes collected in the first day of hospital admission during usual care as input to natural language processing and machine learning algorithm.
Primary Outcome Measure Information:
Title
Proportion of patients that had a universal screen positive and received SBIRT (screening, brief intervention, or referral to treatment)
Description
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
54 months
Secondary Outcome Measure Information:
Title
All-cause re-hospitalizations following 6-months from the Index hospital encounter
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Majid Afshar, MD
Phone
3125459462
Email
majid.afshar@wisc.edu
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Keshavarzian
Email
ali_keshavarzian@rush.edu
First Name & Middle Initial & Last Name & Degree
Jenna Nikolaides
Email
jenna_nikolaides@rush.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The patient data are protected health information and unavailable to public but the algorithm will be shared. The investigators will serialize our best models developed using either pickle (a Python native mechanism for object serialization) or joblib (https://pythonhosted.org/joblib/) and write software that will be capable of reloading them and making predictions. The software will be distributed via github.com or similar web-based software hosting service.
IPD Sharing Time Frame
12 months after completion of study and available for at least five years on github.com
IPD Sharing URL
http://github.com
Citations:
PubMed Identifier
30602031
Citation
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 validation. J Am Med Inform Assoc. 2019 Mar 1;26(3):254-261. doi: 10.1093/jamia/ocy166.
Results Reference
result
Links:
URL
https://github.com/
Description
login page but full code not finalized for publishing
Learn more about this trial
Data-driven Identification for Substance Misuse
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