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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03837418
Recruitment Status : Withdrawn (Investigator is no longer at Northwestern University.)
First Posted : February 12, 2019
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Stephanie Rangel, Northwestern University

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
Programming Languages Patients

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.

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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 : January 17, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2026



Primary Outcome Measures :
  1. Evaluation of Differences between Ideal and Actual Performance of Prescriptions by Number of Deviations between Sequences of Events [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 79 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at Northwestern Memorial Hospital, Northwestern Medicine Clinics, Lurie Children's Clinics, and Lurie Children's Hospital between the ages of 0-79.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837418


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Steven M Belknap, MD Northwestern University
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Responsible Party: Stephanie Rangel, Research Assistant Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT03837418    
Other Study ID Numbers: SMB03092018
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie Rangel, Northwestern University:
Patient-Oriented
Designing
Prescriptions