Achieving Diagnostic Excellence Through Prevention and Teamwork
ConditionDiagnostic Errors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Admitted for a non-medical reason
Patients coded in the field who are moribund on arrival to the hospital
Trial design
Design model
Single group
Treatments tested in this trial
ADEPT Program
BehavioralIntegration 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.
Treatment groups
7,200 Participants
are divided into 2 treatment groupsGroup A: Pre-intervention (usual care)No intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic Errors
Proportion of patients in each trigger category (death, ICU transfer, rapid response) with an adjudicated diagnostic error.
Time frame
Through hospital discharge, an average of 10 daysSecondary outcomes
1
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.
Time frame
Through hospital discharge, an average of 10 days2
Diagnostic process faults
Number of diagnostic process faults per patient, as determined by the DEER taxonomy during adjudication
Time frame
Through hospital discharge, an average of 10 daysOther outcomes
1
Reach
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.
Time frame
Duration of the program (3 years)2
Adoption
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.
Time frame
Duration of the program (3 years)3
Implementation
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.
Time frame
Duration of the program (3 years)4
Maintenance
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.
Time frame
Duration of the program (3 years) plus 6 monthsSponsors and contacts
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Brigham and Women's Hospital
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov