Data-driven Identification for Substance Misuse

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03833804
Collaborator
Rush University Medical Center (Other)
34,800
1
19.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Processing of clinical notes in the EHR data collected during routine care
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34800 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Quasi-experimental design as an interrupted time seriesQuasi-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.
Primary Purpose:
Screening
Official Title:
Data-driven Strategies for Substance Misuse Identification in Hospitalized Patients
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jan 30, 2025
Anticipated Study Completion Date :
Mar 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: NLP (natural language processing) pre-screen

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients that had a universal screen positive and received SBIRT (screening, brief intervention, or referral to treatment) [54 months]

    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

  1. All-cause re-hospitalizations following 6-months from the Index hospital encounter [12 months enrollment with 6 months follow-up for rehospitalization]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Wisconsin, Madison
  • Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT03833804
Other Study ID Numbers:
  • 211165
  • A534285
  • SMPH/MEDICINE
First Posted:
Feb 7, 2019
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Wisconsin, Madison
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2022