POP-PL: Designing a Programming Language for Patient-Oriented Prescriptions

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT02820168
Collaborator
(none)
56
2
35.5
28
0.8

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 :
    56 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Designing a Programming Language for Patient-Oriented Prescriptions
    Actual Study Start Date :
    Feb 1, 2016
    Actual Primary Completion Date :
    Jan 17, 2019
    Actual Study Completion Date :
    Jan 17, 2019

    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:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients between the ages of 18 and 50 years old who receive care at the Northwestern Maternal Fetal Medicine Clinic (MFM)

    • Patients between the ages of 18 and 50 years old who visit Northwestern Medicine outpatient facilities and are patients of a clinician who is a coinvestigator on this project.

    • Patients who are between the ages of 18 and 50 years old, are hospitalized at Northwestern Medicine inpatient facilities, and are patients of a clinician who is a coinvestigator on this project.

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern Medicine Clinics Chicago Illinois United States 60611
    2 Northwestern Memorial Hospital 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:
    Steven M Belknap, Research Assistant Professor, Dermatology, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT02820168
    Other Study ID Numbers:
    • SMB01262016
    First Posted:
    Jun 30, 2016
    Last Update Posted:
    Feb 12, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Steven M Belknap, Research Assistant Professor, Dermatology, Northwestern University

    Study Results

    No Results Posted as of Feb 12, 2019