ADEPT Program for Diagnostic Errors

(ADEPT Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce diagnostic errors in hospitals by connecting different facilities to share data and improve diagnostic processes. Researchers seek to understand why diagnostic errors occur and find ways for hospitals, doctors, and patients to collaborate in preventing them. The study includes two groups: one will receive the usual care, while the other will participate in a new program called the ADEPT Program to improve diagnosis. The trial seeks adult patients admitted to a hospital's general medicine service who experienced serious incidents, such as late transfers to the ICU. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance diagnostic accuracy and patient safety across hospitals.

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 prior data suggests that this program is safe for improving diagnostic processes?

Research has shown that the ADEPT Program is a real-world effort to enhance quality and safety in hospitals. It assists hospitals in identifying and correcting diagnostic errors. Specific safety data for this program does not exist because it is not a medical treatment but a tool for hospital use. The goal is to improve diagnostic accuracy and prevent errors that could harm patients. As the program focuses on refining hospital procedures rather than testing new drugs, typical safety concerns like side effects do not apply. The program encourages hospitals to learn from one another to improve patient diagnosis and treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ADEPT Program for Diagnostic Errors because it aims to tackle the persistent issue of diagnostic mistakes in hospitals. Unlike traditional methods that rely heavily on individual clinician judgment, the ADEPT Program introduces a systematic approach to improve diagnostic accuracy over a sustained period. By implementing this program, researchers hope to uncover strategies that could significantly reduce errors and enhance patient safety, which could lead to better outcomes across healthcare settings.

What evidence suggests that the ADEPT Program is effective for reducing diagnostic errors?

Research shows that the ADEPT Program, tested in this trial, aims to reduce diagnostic errors in hospitals. These errors occur frequently, with some studies showing error rates around 24%. The program improves how hospitals track and share diagnostic information. By doing so, hospitals can learn from each other and enhance accuracy. Early findings suggest that this approach helps hospitals identify and address common causes of these errors, leading to better patient care and fewer incorrect diagnoses. ^{1 3 4 6 7}

Who Is on the Research Team?

Andrew Auerbach, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964432/

Achieving diagnostic excellence through prevention and ... Assuming a combined diagnostic error rate of 24% in the preintervention period (boldfaced row in Table S1), we will achieve 80% power to detect ...

2. withpower.com withpower.com/trial/phase-diagnostic-errors-2-2023-60dc3

ADEPT Program for Diagnostic Errors · Info for Participants 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, ...

3. shmpublications.onlinelibrary.wiley.com shmpublications.onlinelibrary.wiley.com/doi/abs/10.1002/jhm.13230

Achieving diagnostic excellence through prevention and ... The ADEPT study is a multicenter program to improve diagnostic processes by building surveillance, benchmarking performance, and evaluating ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37888951/

Achieving diagnostic excellence through prevention ... - PubMed The ADEPT study aims to build surveillance for diagnostic errors, benchmark performance, and evaluate interventions using a multicenter, real-world program.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0169260725002779

ADEPT: An advanced data exploration and processing tool ... The ADEPT simplifies the preprocessing of medical data, prioritizing the efficiency and accuracy of data processing. The framework includes functional modules ...

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05747755

Achieving Diagnostic Excellence Through Prevention and ... 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.

7. ahrq.gov ahrq.gov/diagnostic-safety/research/grants-2022.html

Diagnostic Safety Centers of Excellence Grants Awarded in ... The goals of the ADEPT Diagnostic Center of Excellence are to link a group of hospitals to measure and share the rates of diagnostic error, understand ...