Learning Lab for Diagnostic Fidelity

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 25551

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Mankato, Minnesota, United States, 56001
      • Mayo Clinic Health System - Mankato MCHS
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. All patients at risk of diagnostic error will be eligible for the study.
2. We will include both sexes and all genders and all minority populations as they present with the risk of diagnostic error in the hospitals.

Given the nature of the study, which focuses on patients with or at risk of diagnostic error, outreach efforts to underrepresented populations or individuals would not be possible.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of automated phenotypes	Use data from the patient electronic medical record to identify the number of diagnostic error or delay to validate clinical environment automated phenotypes	1 year
Adoption (Number of time the Control Tower used during the clinical encounters)	Standardized process tracking sheets to track each time the control tower system is triggered and used.	1 year
Implementation Acceptability	Focused questions about beliefs, attitudes, usability by healthcare providers	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Brian W Pickering, M.B., B.Ch., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2019
• Primary Completion (ACTUAL): November 30, 2022
• Study Completion (ACTUAL): November 30, 2022

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (ACTUAL): March 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Patient Safety; Critical Illness; Delivery of Health Care; Electronic Health Records
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 18-007115; R18HS026609 (AHRQ)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No