Clinical trial NCT03865303: Learning Lab for Diagnostic Fidelity
Official title: Acute Care Learning Laboratory-Reducing Threats to Diagnostic Fidelity in Critical Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Critical Illness
Patient Safety
Delivery of Health Care
Electronic Health Records
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2019-03-06
Enrollment: 25551
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of automated phenotypes
timeFrame: 1 year
measure: Adoption (Number of time the Control Tower used during the clinical encounters)
timeFrame: 1 year
measure: Implementation Acceptability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mankato
country: United States
facility: Mayo Clinic Health System - Mankato MCHS
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brian W Pickering, M.B., B.Ch.
role: PRINCIPAL_INVESTIGATOR
References: