Clinical trial NCT05747755: Achieving Diagnostic Excellence Through Prevention and Teamwork
Official title: Achieving Diagnostic Excellence Through Prevention and Teamwork (ADEPT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diagnostic Errors
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: University of California, San Francisco
First posted: 2023-02-28
Enrollment: 7200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Interrupted time series
Primary purpose: DIAGNOSTIC

Brief summary: This study seeks to link a group of hospitals to measure and share the rates of diagnostic errors, to understand underlying causes of diagnostic errors, and develop ways that hospitals, clinicians, and patients can work together to avoid diagnostic errors and harms due to those errors. The investigators will test how data sharing and collaboration improve diagnostic processes and develop approaches which can be sustained into the future. The approach represents a novel application of rigorous outcome adjudication to the problem of inpatient diagnostic errors using a learning health system model.

Detailed description: Many factors contribute to diagnostic errors, but key among them are foundational issues in healthcare: complex and fragmented care systems, the limited time available to providers trying to ascertain a firm diagnosis, and the work systems and cultures that support or impede improvements in diagnostic performance. While approaches to identifying diagnostic errors exist, few studies have linked identification of underlying systemic and structural causes of errors to existing quality improvement programs in hospitals. Even fewer have applied resilience theories or positive deviance approaches to characterize the features of cases where the diagnostic process is optimal and then use those findings to frame health system improvement.

This application builds directly on the investigators' currently funded study - Utility of Predictive Systems in Diagnostic Errors (UPSIDE) - which is defining risk factors, underlying causes, and prevalence of diagnostic errors among patients admitted to hospitals participating in a 55-hospital research collaborative, the Hospital Medicine Reengineering Network (HOMERuN). UPSIDE has developed reference standard approaches to adjudication of diagnostic errors, defined factors associated with errors, and created collaborations with participating sites and national organizations, providing a uniquely powerful opportunity to transform how diagnostic process evaluation programs can be used to improve patient safety.

The overall goal of this Center is to turn the investigators' highly successful multicenter network into a diagnostic error learning health system that will integrate diagnostic error assessments into existing quality and safety programs, provide support and expertise needed to reduce diagnostic errors, and catalyze scientific, personnel, and infrastructure changes which will last beyond the duration of this grant.

To achieve the study's overall goals, the investigators will: 1) Implement a case review infrastructure which can accurately identify diagnostic errors and characterize diagnostic processes among patients suffering inpatient deaths, ICU transfers, or rapid-response team calls taking place at hospitals associated the Hospital Medicine Reengineering Network; 2) Develop site-level audit and feedback and group-wide benchmarking reports of error rates, diagnostic process faults, diagnostic process resilience features and use these data to frame collaboration between existing safety and quality programs at participating sites; 3) Use the data and collaborative model to develop and pilot test interventions based on highest priority findings; and 4) Develop understanding of the program's reach, adoption, implementation, and maintenance, as well feasibility and initial experience with pilot interventions. This project will establish a learning health system which can achieve excellence in diagnosis as an ongoing part of care, a system which can be a model for others as well.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to general medicine services at one of the participating hospitals and who either died during the hospitalization, were transferred to the ICU \>= 48 hours after admission, or had a rapid response.

Exclusion Criteria:

* Admitted for a non-medical reason
* Patients coded in the field who are moribund on arrival to the hospital

Primary outcomes:
measure: Diagnostic Errors
timeFrame: Through hospital discharge, an average of 10 days
Secondary outcomes:
measure: Harmful Diagnostic Errors
timeFrame: Through hospital discharge, an average of 10 days
measure: Diagnostic process faults
timeFrame: Through hospital discharge, an average of 10 days
Other outcomes:
measure: Reach
timeFrame: Duration of the program (3 years)
measure: Adoption
timeFrame: Duration of the program (3 years)
measure: Implementation
timeFrame: Duration of the program (3 years)
measure: Maintenance
timeFrame: Duration of the program (3 years) plus 6 months
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: University of California, San Francisco
name: Andrew Auerbach
role: PRINCIPAL_INVESTIGATOR
References: