Clinical trial NCT02820168: Designing a Programming Language for Patient-Oriented Prescriptions
Official title: Designing a Programming Language for Patient-Oriented Prescriptions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients
Programming Languages
Keywords: Designing
Patient-Oriented
Prescriptions
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen at Northwestern Memorial Hospital and Northwestern Medicine Clinics

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.

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Evaluation of Differences between Ideal and Actual Performance of Prescriptions by Number of Deviations between Sequences of Events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Clinics
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Steven M Belknap, MD
role: PRINCIPAL_INVESTIGATOR
References: