ADEPT Program for Diagnostic Errors

(ADEPT Trial)

Recruiting at 1 trial location

Overseen By Tiffany Lee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Non-medical admission, Moribund on arrival

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

7200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the ADEPT Program treatment for diagnostic errors?

The effectiveness of the ADEPT Program for diagnostic errors may be supported by similar improvement programs, such as the Realizing Improvement through Team Empowerment (RITE) program, which showed that team-based problem-solving and structured methods led to modest improvements in healthcare settings. Additionally, process improvement techniques have been effective in reducing errors, as seen in the reduction of chemotherapy-related medication errors by 23%. ^{1 2 3 4 5}

Is the ADEPT Program for Diagnostic Errors safe for humans?

The research articles provided do not contain specific safety data for the ADEPT Program for Diagnostic Errors or any related treatments. ^{6 7 8 9 10}

How does the ADEPT Program for Diagnostic Errors treatment differ from other treatments for diagnostic errors?

The ADEPT Program is unique because it focuses on identifying and reducing diagnostic errors through innovative tools and processes, such as 'trigger' tools and quality improvement initiatives, rather than traditional medical treatments. This approach aims to improve diagnostic accuracy and patient safety by addressing the root causes of errors in the diagnostic process. ^{11 12 13 14 15}

Research Team

Andrew Auerbach, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adult patients admitted to general medicine services at participating hospitals who either passed away during their stay, were moved to the ICU more than 48 hours after admission, or required rapid response intervention. It excludes those admitted for non-medical reasons or who were critically ill upon arrival.

Inclusion Criteria

I was admitted to a hospital, and either passed away, moved to ICU after 2 days, or had an emergency response.

Exclusion Criteria

Admitted for a non-medical reason

Patients coded in the field who are moribund on arrival to the hospital

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention (usual care)

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

12 months

Intervention

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

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• ADEPT Program

Trial Overview The ADEPT Program aims to reduce diagnostic errors in hospitals by sharing data and collaborating on improving diagnostic processes. The program will develop sustainable methods within a learning health system model to enhance accuracy in diagnosing patient conditions.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Pre-intervention (usual care) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Findings from Research

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

The transition from ICD-9-CM to ICD-10-CM coding systems could lead to significant errors in hospital safety reporting, particularly affecting the accuracy of Patient Safety Indicators (PSIs) across 38,644 patients and 399 hospitals.

Out of 23 PSIs analyzed, 15 showed inaccuracies due to the complexity of coding translations, which could inflate reported safety incidents and complicate comparisons of hospital safety performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and remediation for Patient Safety Indicators in the transition to ICD-10-CM. Boyd, AD., Yang, YM., Li, J., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Applying the Chronic Care Model to Improve Care and Outcomes at a Pediatric Medical Center. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The $6 million question: can process improvement ensure appropriate hospitalizations? [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Breaking the mold: new paradigms for physician leadership in patient safety. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Realizing Improvement through Team Empowerment (RITE): A Team-based, Project-based Multidisciplinary Improvement Program. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A continuous-improvement approach for reducing the number of chemotherapy-related medication errors. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Secular trends in diagnostic code density in electronic healthcare data from health care systems in the Vaccine Safety Datalink project. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

The Irony of MedWatch and the FAERS Database: An Assessment of Data Input Errors and Potential Consequences. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

9. England pubmed.ncbi.nlm.nih.gov

Application of electronic trigger tools to identify targets for improving diagnostic safety. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Challenges and remediation for Patient Safety Indicators in the transition to ICD-10-CM. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Clinical criteria to screen for inpatient diagnostic errors: a scoping review. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The next organizational challenge: finding and addressing diagnostic error. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Developing Health Care Organizations That Pursue Learning and Exploration of Diagnostic Excellence: An Action Plan. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Quality Improvement in a Pediatric Echocardiography Laboratory: A Collaborative Process. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

The Diagnostic Error Index: A Quality Improvement Initiative to Identify and Measure Diagnostic Errors. [2021]