ADEPT: Achieving Diagnostic Excellence Through Prevention and Teamwork

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05747755
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed), University of California, San Francisco (Other)
7,200
2
2
42.1
3600
85.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ADEPT Program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
7200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Interrupted time seriesInterrupted time series
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Achieving Diagnostic Excellence Through Prevention and Teamwork (ADEPT)
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic Errors [Through hospital discharge, an average of 10 days]

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

Secondary Outcome Measures

  1. Harmful Diagnostic Errors [Through hospital discharge, an average of 10 days]

    Proportion of patients in each trigger category with diagnostic errors contributing to death, permanent harm, or requiring life-sustaining treatment using NCC-MERP criteria.

  2. Diagnostic process faults [Through hospital discharge, an average of 10 days]

    Number of diagnostic process faults per patient, as determined by the DEER taxonomy during adjudication

Other Outcome Measures

  1. Reach [Duration of the program (3 years)]

    Description of hospitals, teams, or units where our diagnostic error measurement methodology is built into usual care (Aim 1), where benchmarking data are incorporated into usual care (Aim 2), and whether and which pilot interventions are adopted (Aim 3) compared with those where they are not adopted, and a description of patients who receive patient-level interventions (Aim 3) compared with those who do not.

  2. Adoption [Duration of the program (3 years)]

    Number and types of audit/feedback, benchmarking, and Safety I and Safety II interventions adopted at each site, as well as units, teams, and clinician types that do and do not adopt interventions.

  3. Implementation [Duration of the program (3 years)]

    Proportion of patients in each trigger population who undergo adjudication for diagnostic error, the number of surveys administered and interviews conducted with medical teams (in the presence of error and for good catches), the number of benchmarking reports produced, the number of audit/feedback sessions conducted, and (if they can be tracked) the proportion of patients who receive patient-level interventions.

  4. Maintenance [Duration of the program (3 years) plus 6 months]

    Proportion of patients in each trigger category (death, ICU transfer, rapid response) with an adjudicated diagnostic error 6 months after after the end of collaborative calls with sites.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Francisco San Francisco California United States 94143
2 Brigham & Women's Hospital Boston Massachusetts United States 02120

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Andrew Auerbach, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeffrey L. Schnipper, MD.,MPH., Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05747755
Other Study ID Numbers:
  • 2023P000031
  • R18HS029366
  • 355948
First Posted:
Feb 28, 2023
Last Update Posted:
Mar 7, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 7, 2023