Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT05747755

Conditions

Diagnostic Errors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADEPT Program

Study Details

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

Study ID

NCT05747755

Start date

Nov 14, 2023

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Sep 1, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

7200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Pre-intervention (usual care)

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

experimental: Intervention

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

Interventions

ADEPT Program

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.

Primary outcome measure

  • Diagnostic Errors [ Time Frame: Through hospital discharge, an average of 10 days ]

Central Contacts and Locations

Central contacts

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02120

Contacts

Jeffrey L Schnipper, MD, MPH

617-732-6201jschnipper@partners.org

Principal Investigator:

Jeffrey L Schnipper, MD, MPH

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 8, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-09-08.