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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03837418
Other study ID # SMB03092018
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 17, 2019
Est. completion date June 2026

Study information

Verified date October 2020
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2026
Est. primary completion date June 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 79 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of Differences between Ideal and Actual Performance of Prescriptions by Number of Deviations between Sequences of Events 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. 2 years
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