Achieving Diagnostic Excellence Through Prevention and Teamwork

NCT05747755 | Not Yet Recruiting

• 3 other identifiers: 2023P000031R18HS029366355948
• Study Type: interventional
• Target: 7,200
• Locations: 1 country
• Sites: 2

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.

Conditions

Diagnostic Errors

Outcome Measures

Primary Outcomes (1)

• Diagnostic Errors

  Proportion of patients in each trigger category (death, ICU transfer, rapid response) with an adjudicated diagnostic error.

  Through hospital discharge, an average of 10 days

Secondary Outcomes (2)

• Harmful Diagnostic Errors

  Through hospital discharge, an average of 10 days

• Diagnostic process faults

  Through hospital discharge, an average of 10 days

Other Outcomes (4)

• Reach

  Duration of the program (3 years)

• Adoption

  Duration of the program (3 years)

• Implementation

  Duration of the program (3 years)

Study Arms (2)

Pre-intervention (usual care)

NO INTERVENTION

Patients admitted to study hospitals in the 12 months prior to the start of the intervention

Intervention

EXPERIMENTAL

Patients admitted to study hospitals during the 36 months of the intervention

Behavioral: ADEPT Program

Interventions

ADEPT Program BEHAVIORAL

Integration of surveillance for diagnostic errors into usual care, benchmarking and sharing of results across hospitals, expert mentoring of quality and safety personnel in change management, pilot testing and refinement of Safety I and Safety II interventions to reduce systemic causes of diagnostic errors and to increase resilience, thus promoting diagnostic excellence.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• University of California, San Francisco: collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Study Officials

• Andrew Auerbach

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Lee

CONTACT

415-476-6949; tiffany.lee@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Interrupted time series

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 28, 2023
• Study Start: March 1, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

US (2)