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OpenTrials
Completed

NCT Number: NCT05251844

The Effectiveness of Email Alerting on Reducing Employees' Unauthorized Access to Protected Health Information

To assess the effectiveness of email warnings on reducing repeated unauthorized access to Protected Health Information (PHI), a randomized trial was conducted in a large academic medical center to understand the effectiveness of email warning on reducing repeated unauthorized access to PHI.

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Key information

Conditions

Unauthorized Data Access

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Protenus, Inc.

Baltimore, Maryland, 21231, United States

About this study

From January 1, 2018, to July 31, 2018, a large academic medical center's PHI access monitoring system flagged all unauthorized accesses to patient electronic medical records from 444 employees (all professional medical staff), who were not part of the patient's intervention team and did not have access permission. 219 employees (49%) were randomly selected to receive an email warning on the night of their access, while the remaining employees (225, 51%) served as controls. The email informed that the employee has had been identified as having accessed a patient's electronic medical record without a known work-related purpose and that unauthorized access is a privacy violation. A sample email was attached at the end of the protocol.

The system tracked all these individuals' violations within the sample period. Later on, all cases with the violators' ID and patients' ID fully de-identified (see the following excerpt as examples) were shared with researchers at John Hopkins and Michigan State for data analyses. Because researchers do not have the ability to link the data with an identifier, the study was exempted from Michigan State University's IRB review.

Violator ID Patient ID Date Intervention 01B1NSYX3CEXZ86UZXU7R9JQ4VEK R7Z8RTZQL4B9IAC13F6EXQJVWAI7 1/2/2018 No Email

01B1NSYX3CEXZ86UZXU7R9JQ4VEK R7Z8RTZQL4B9IAC13F6EXQJVWAI7 1/3/2018 No Email

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • violators of patients' privacy rights

Exclusion criteria

-

Treatment and study plan

receiving an email

Other

The email informed that the employee has had been identified as having accessed a patient's electronic medical record without a known work-related purpose and that unauthorized access is a privacy violation.

Primary outcomes

  1. the number of subsequent unauthorizated access violations

    Time frame: 12 weeks starting from the first time a violation was flagged

    The investigators monitored and collected all the subsequent unauthorized access violations for both the experiment and the control group

Sponsors and collaborators

Lead sponsor

Protenus, Inc.

Industry

Registry information

Official study title

Effectiveness of Email Alerting on Reducing Hospital Employees' Unauthorized Access to Protected Health Information: A Nonrandomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2021
First posted
Feb 23, 2022
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.