- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820168
Designing a Programming Language for Patient-Oriented Prescriptions (POP-PL)
February 8, 2019 updated by: Steven M Belknap, Northwestern University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
Chicago, Illinois, United States, 60611
- Northwestern Medicine Clinics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients seen at Northwestern Memorial Hospital and Northwestern Medicine Clinics
Description
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:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven M Belknap, MD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
January 17, 2019
Study Completion (Actual)
January 17, 2019
Study Registration Dates
First Submitted
May 16, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
June 30, 2016
Study Record Updates
Last Update Posted (Actual)
February 12, 2019
Last Update Submitted That Met QC Criteria
February 8, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SMB01262016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients
-
Beni-Suef UniversityCompletedSeptic Patients | Nonseptic PatientsEgypt
-
Universidade Federal de PernambucoCompleted
-
Hopital of MelunCompletedCritical Ill Patients | Ventilated PatientsFrance
-
EarlySense Ltd.WithdrawnPost Operative Patient | Patients Requiring PCA | Respiratory Patients | Patients in Risk of FallUnited States
-
RWTH Aachen UniversityCompletedCardiac Surgery Patients | Elderly Patients | Neurosurgical Patients | Obese Patients | Abdominal Surgery PatientsGermany
-
Bayside HealthCompletedMechanically Ventilated Patients | Intensive Care | Sedated PatientsAustralia
-
Meir Medical CenterUnknownPatients With Normal ECG | Patients With Pathological ECGIsrael
-
Shaare Zedek Medical CenterUnknownPatients Undergoing Open Heart Surgery | Patients Undergoing Lung SurgeryIsrael
-
China Medical University HospitalUnknownSurgical Patients | Hospitalized PatientsTaiwan
-
Centre Hospitalier Universitaire DijonTerminatedHigh Cardiovascular Risk Patients | Low Cardiovascular Risk PatientsFrance