DESIGNING A PROGRAMMING LANGUAGE FOR PATIENT-ORIENTED PRESCRIPTIONS (POP-PL)

Sponsor
Northwestern University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03837418
Collaborator
(none)
0
1
88.4
0

Study Details

Study Description

Brief Summary

The purpose of this study is to create a human-readable and executable computer language to implement medical prescriptions and to evaluate and refine this language, with the goal of improving safety and efficacy of patient care

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Preventable errors in healthcare are a leading cause of patient injury and death. Despite extensive effort and the expenditure of billions of dollars, computerization has failed to solve this problem. Research has shown that software design and debugging of a paper prescription markedly decreases the rate of injury and death associated with use of opioids in hospitalized patients. To further the application of insights from software engineering to the practice of medicine, the PIs will design and build a Patient-Oriented Prescription Programming Language (POP-PL) and evaluate if this new platform can be used to improve medical management of patients. The design of POP-PL will be based on building an understanding of the process of medical treatment of patients. This project is a collaboration between computer scientists and clinicians at Northwestern Medicine. The collaborating clinicians are co-investigators on this research project and also are providing healthcare to the patients that are being observed. The computer scientists and other research staff have undergone human subjects research training and are co-investigators on this research project as well. The clinician-investigators will oversee research project staff during all observations of patients, clinical encounters between healthcare providers and patients, and interactions between healthcare providers and healthcare information systems. Researchers involved in this study will observe interactions between health care providers and patients and will collate these observations with data from electronic data sources. Since this research is based mainly upon observation and chart review and will not involve any interventions or changes to patient care, the risk to study participants is minimal, involving inadvertent disclosure of healthcare information. This risk will be mitigated by anonymizing collected data.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    DESIGNING A PROGRAMMING LANGUAGE FOR PATIENT-ORIENTED PRESCRIPTIONS (POP-PL)
    Actual Study Start Date :
    Jan 17, 2019
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of Differences between Ideal and Actual Performance of Prescriptions by Number of Deviations between Sequences of Events [2 years]

      Investigators will express the intent of prescriptions in prescription programming language. Investigators will then compare the actual performance of the prescription in a clinical environment to the performance of the prescription in a simulated environment based on the same inputs as occurred in the real clinical environment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients seen at Northwestern Memorial Hospital, Northwestern Medicine Clinics, Lurie Children's Clinics, and Lurie Children's Hospital between the ages of 0-79.
    Exclusion Criteria:
    • Patients without data within the NMEDW medical record database or LCH CDW or BIS medical record database.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Steven M Belknap, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephanie Rangel, Research Assistant Professor of Dermatology, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT03837418
    Other Study ID Numbers:
    • SMB03092018
    First Posted:
    Feb 12, 2019
    Last Update Posted:
    Oct 9, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stephanie Rangel, Research Assistant Professor of Dermatology, Northwestern University

    Study Results

    No Results Posted as of Oct 9, 2020