Diagnostic ErrorsADEPTNCT05747755
Achieving Diagnostic Excellence Through Prevention and Teamwork
A study testing ADEPT Program in people with Diagnostic Errors, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic Errors
- What is being tested?
- ADEPT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Nov 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Admitted for a non-medical reason
- Patients coded in the field who are moribund on arrival to the hospital
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02120
Jeffrey L Schnipper, MD, MPH, 617-732-6201, jschnipper@partners.org
Jeffrey L Schnipper, MD, MPH
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Tiffany Lee, 415-476-6949, tiffany.lee@ucsf.edu
Andrew Auerbach, MD, MPH, andrew.auerbach@ucsf.edu
About this study
Official title: Achieving Diagnostic Excellence Through Prevention and Teamwork (ADEPT)
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.
Read the 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.
- Conditions
- Diagnostic Errors
- Being tested
- ADEPT Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADEPT ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: ADEPT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Errors
Proportion of patients in each trigger category (death, ICU transfer, rapid response) with an adjudicated diagnostic error.
Measured: Through hospital discharge, an average of 10 days
Secondary outcomes (2)
Harmful Diagnostic Errors
Proportion of patients in each trigger category with diagnostic errors contributing to death, permanent harm, or requiring life-sustaining treatment using NCC-MERP criteria.
Measured: Through hospital discharge, an average of 10 days
Diagnostic process faults
Number of diagnostic process faults per patient, as determined by the DEER taxonomy during adjudication
Measured: Through hospital discharge, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start14 Nov 2023
- Primary completion1 Sep 2026
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ErrorsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Interrupted time series
- Masking
- None (open label)
- Enrolment
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of California, San Francisco
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
- Investigators
- Andrew Auerbach, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747755
- Sponsor's protocol ID
- 2023P000031
- Other IDs
- R18HS029366, 355948
- Acronym
- ADEPT
- Status last verified
- Aug 2026
- First submitted
- 7 Feb 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Diagnostic Excellence Through Prevention and Teamwork (ADEPT)
- ClinicalTrials.gov ID
- NCT05747755
- Acronym / sponsor ID
- ADEPT / 2023P000031
- Conditions
- Diagnostic Errors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of California, San Francisco
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interrupted time series
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention (usual care) | No intervention | –Patients admitted to study hospitals in the 12 months prior to the start of the intervention |
| Intervention | Experimental | Behavioral: ADEPT ProgramPatients admitted to study hospitals during the 36 months of the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Admitted for a non-medical reason
- Patients coded in the field who are moribund on arrival to the hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADEPT ProgramIntegration 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. | Behavioural | Intervention |
Primary outcome
Diagnostic Errors
Time frame: 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.
2 secondary outcomes
Harmful Diagnostic Errors
Time frame: Through hospital discharge, an average of 10 days
Diagnostic process faults
Time frame: Through hospital discharge, an average of 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Auerbach principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADEPT Program in people with Diagnostic Errors, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Lee (415-476-6949, tiffany.lee@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Errors (time frame: Through hospital discharge, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.