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NCT04393909 · ClinicalTrials.gov registry record · NA

Improving Safety of Diagnosis and Therapy in the Inpatient Setting

A NA study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
NA
Development phase
700
Enrollment target

NCT04393909: Completed NA study, sponsored by Brigham and Women's Hospital.

NCT04393909 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 700 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04393909, a NA study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
NA
Development phase
700 participants
Enrollment target

Study Summary

To improve the safety of diagnosis and therapy for a set of conditions and undifferentiated symptoms for hospitalized patients, the investigators will employ a set of methods and tools from the disciplines of systems engineering, human factors, quality improvement,and data analytics to thoroughly analyze the problem, design and develop potential solutions that leverage existing current technological infrastructure, and implement and evaluate the final interventions. The investigators will engage the interdisciplinary care team and patient (or their caregivers) to ensure treatment trajectories match the anticipated course for working diagnoses (or symptoms), and whether they are in line with patient and clinician expectations. The investigators will use an Interrupted time series (ITS) design to assess impact on diagnostic errors that lead to patient harm. The investigators will perform quantitative and qualitative evaluations using implementation science principles to understand if the interventions worked, and why or why not.

Primary Outcome

Data Source: Chart audit Analytic Variables: * % patients with diagnostic error * % patients with diagnostic error with actual or potential AE (i.e., harmful DE) * % patients with diagnostic error with actual or potential AE that was severe (i.e., harmful and severe DE) * % patients with diagnostic error with actual or potential AE that was preventable (i.e., harmful, severe, and preventable DE)

Interventions

  • BEHAVIORAL Diagnostic Uncertainty Educational Curriculum
  • BEHAVIORAL Diagnostic Timeout
  • BEHAVIORAL Patient Diagnostic (Dx) Questionnaire
  • BEHAVIORAL Enhancements to Epic-integrated Quality & Safety Dashboard

Trial Details

FieldValue
Enrollment Target 700 participants
Start Date 2019-07-01
Est. Completion 2021-12-30
Phase NA
Brigham and Women's Hospital

937 total trials

What the finished NCT04393909 record still lists

NCT04393909 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 4 interventions - of which Diagnostic Uncertainty Educational Curriculum is the first listed.

NCT04393909 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04393909 about?

NCT04393909 is a clinical study titled "Improving Safety of Diagnosis and Therapy in the Inpatient Setting". To improve the safety of diagnosis and therapy for a set of conditions and undifferentiated symptoms for hospitalized patients, the investigators will employ a set of methods and tools from the disciplines of systems engineering, human factors, quality improvement,and data analytics to thoroughly an...

What is the current status of trial NCT04393909?

This trial is currently completed. It is a NA study. The enrollment target is 700 participants. The study started on 2019-07-01. Estimated completion is 2021-12-30.

What interventions are being tested in trial NCT04393909?

The interventions under investigation include: Diagnostic Uncertainty Educational Curriculum (BEHAVIORAL), Diagnostic Timeout (BEHAVIORAL), Patient Diagnostic (Dx) Questionnaire (BEHAVIORAL), Enhancements to Epic-integrated Quality & Safety Dashboard (BEHAVIORAL).

Who is sponsoring clinical trial NCT04393909?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04393909's enrollment target sits among peer trials

700 149th of 2000 higher than 1,850 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04393909, the US trial registry maintained by the National Library of Medicine. NCT04393909 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.