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Completed

NCT Number: NCT03865303

Learning Lab for Diagnostic Fidelity

Diagnostic error and delay remain a leading cause of preventable harm and death in the United States. Using a learning laboratory structure, researchers will implement mixed-methods research approaches to identify the systemic weaknesses that contribute to diagnostic error and delay in the hospital setting. The knowledge gained from research innovative will allow researchers to design, develop, implement, and refined a suite of human-centered tools that can be deployed to reduce the risk of diagnostic error and delay in both community and academic hospital settings.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Health System - Mankato MCHS, Mankato, Minnesota, United States

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About this study

Despite the recognition that diagnostic errors an delays are a major contributor to preventable deaths in the USA, little progress has been made to reduce mortality outcomes from this known killer. An effective strategy leading to meaningful reduction in diagnostic error and delay rates has not made its way into practice. This proposal is unique and novel and combines mixed-methods research approaches with systems engineering research approaches to understand the interplay of the multiple factors contributing to diagnostic error and delay. The knowledge gained from this holistic approach will then be used within the learning laboratory to inform the design, development, evaluation, and refinement of the solutions to diagnostic error and delay. "Control Tower" will be the staging ground for the in situ learning laboratory and will be built on top of a well-established clinical informatics infrastructure and hospital environment open to innovation and practice change.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • For EMR review all adults admitted to the hospital ages 18 and older with research authorization
  • For survey-clinicians including physicians, advanced care practitioners
  • For focus groups and interviews-clinicians including physicians, advanced care practitioners

Exclusion criteria

  • Age <18 years old
  • No research authorization
  • Refusal to give consent

Treatment and study plan

Primary outcomes

  1. Validation of automated phenotypes

    Time frame: 1 year

    Use data from the patient electronic medical record to identify the number of diagnostic error or delay to validate clinical environment automated phenotypes

  2. Adoption (Number of time the Control Tower used during the clinical encounters)

    Time frame: 1 year

    Standardized process tracking sheets to track each time the control tower system is triggered and used.

  3. Implementation Acceptability

    Time frame: 1 year

    Focused questions about beliefs, attitudes, usability by healthcare providers

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Acute Care Learning Laboratory-Reducing Threats to Diagnostic Fidelity in Critical Illness

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2019
Registry last updated
Feb 8, 2023

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.

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