Learning Lab for Diagnostic Fidelity

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03865303
• Other study ID #: 18-007115
• Secondary ID: R18HS026609
• Status: Completed
• Start date: April 22, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25551
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
United States	Mayo Clinic Health System - Mankato MCHS	Mankato	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Implementation Acceptability	Focused questions about beliefs, attitudes, usability by healthcare providers	1 year

External Links

•   Mayo Clinic Clinical Trials