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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Automatic Notification System for Test Results Finalized After Discharge

NCT01153451

Test Result Management

COMPLETED NA

Efficacy of a Behavioral Based Education Intervention to Decrease Medication History Errors Among Professional Nurses.

NCT00845494

Medication Errors

UNKNOWN EARLY_PHASE1

The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness

NCT05098743

Medication Adherence Self Efficacy

COMPLETED NA

The Effect of Intensive Inpatient Attending Supervision on Medical Errors, Patient Safety and Resident Education

NCT03318198

Focus of Study is on Graduate Medical Education Supervision

COMPLETED NA

The Effects of a Results Management System on Physician Awareness of Post-Discharge Test Results

NCT00146354

Healthy Medical Record Systems, Computerized

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unauthorized Data Access

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one group received email notice while the group didn't

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

all violators' identities are masked to Protenus.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Email warning

some individuals that accessed patients' data without authorization were randomly selected to receive an email warning. A sample email:

Dear Colleague,

The {Organization} proactive electronic record monitoring system has flagged you as having accessed the electronic patient record of {Patient\_Name} on {Case\_Event\_Date}. A clear work-related purpose has not been identified for this access, and there are no approvals in place by the {Organization} Privacy Office to allow access to this record for personal purposes in accordance with A065. {Organization} takes the privacy of patient information very seriously. The {Organization} Privacy Office is now investigating this access as a potential privacy breach.

This potential noncompliance needs to be resolved immediately. To help determine whether a privacy breach has occurred, please respond to this email with answers to the following questions no later than 5 days from the date of this email...omitted due to length

Group Type EXPERIMENTAL

receiving an email

Intervention Type 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.

No eamil warning

individuals that were flagged as accessing patients' data without authorization on the same day as the experimental group were used as the control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

receiving an email

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.

Intervention Type OTHER