NCT03865303

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,551

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3.6 years

First QC Date

January 4, 2019

Last Update Submit

February 3, 2023

Conditions

Keywords

Critical IllnessPatient SafetyDelivery of Health CareElectronic Health Records

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic Health System - Mankato MCHS

Mankato, Minnesota, 56001, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brian W Pickering, M.B., B.Ch.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pricinple Investigator

Study Record Dates

First Submitted

January 4, 2019

First Posted

March 6, 2019

Study Start

April 22, 2019

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations