An interventional study of Diagnostic Uncertainty Educational Curriculum and Diagnostic Timeout in Delirium, Confusion and Mental Status Change, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Prevention
To improve the safety of diagnosis and therapy for a set of conditions and undifferentiated symptoms for hospitalized patients, the investigators will employ a set of methods and tools from the disciplines of systems engineering, human factors, quality improvement,and data analytics to thoroughly analyze the problem, design and develop potential solutions that leverage existing current technological infrastructure, and implement and evaluate the final interventions. The investigators will engage the interdisciplinary care team and patient (or their caregivers) to ensure treatment trajectories match the anticipated course for working diagnoses (or symptoms), and whether they are in line with patient and clinician expectations. The investigators will use an Interrupted time series (ITS) design to assess impact on diagnostic errors that lead to patient harm. The investigators will perform quantitative and qualitative evaluations using implementation science principles to understand if the interventions worked, and why or why not.
The goal of this study is to improve the safety of diagnosis and therapy for a set of conditions and undifferentiated symptoms for hospitalized patients. The investigators will employ a set of methods and tools from the disciplines of systems engineering, human factors, quality improvement, and implementation science to thoroughly analyze the problem, design and develop potential solutions that leverage the current technological infrastructure, and implement and evaluate the final interventions.
The aims of this study are to:
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's enrollment of 700 is above the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients do not have access to the Patient Dx Questionnaire.
Behavioral: Diagnostic Uncertainty Educational Curriculum · Behavioral: Diagnostic Timeout · Behavioral: Enhancements to Epic-integrated Quality & Safety Dashboard
Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
Behavioral: Diagnostic Uncertainty Educational Curriculum · Behavioral: Diagnostic Timeout · Behavioral: Patient Diagnostic (Dx) Questionnaire · Behavioral: Enhancements to Epic-integrated Quality & Safety Dashboard
A Diagnostic Uncertainty Educational Curriculum will consist of an interactive, one-hour "teach-the-teacher" workshop delivered to resident-attending pairs early on during their inpatient medicine rotation. During the workshop, we will discuss the motivation behind teaching diagnostic uncertainty, review factors that may predict risk of diagnostic error during hospitalization, introduce the framework. Each resident-attending pair will work through a case-based exercise focused on managing learners' diagnostic uncertainty during rounds. Our research team will also conduct Training for clinical staff working on intervention units and will provide "at-the-elbow" support during the intervention period of the main trial.
A "Diagnostic Timeout" is a structured "pocket guide" that clinicians may use to address uncertainty in a step-wise approach for patients who have risk factors for diagnostic error. This tool can be used during or after clinical rounds, inside or outside of a patient's room if the patient is agreeable. The "Diagnostic Timeout" will be introduced as part of the Diagnostic Uncertainty Educational Curriculum as well as Training.
We will administer a survey, the Dx Questionnaire, to patients which asks a series of questions on communication regarding diagnosis with the care team. Patients admitted to inpatient units within the prior 24 hours will be approached after asking the patient's nurse to determine whether it is the appropriate time to approach for enrollment. Upon explaining the objectives of the survey and obtaining verbal informed consent, patients will be asked to complete the Dx Questionnaire via REDCap on an iPad. Alternatively, the research assistant administering the survey will go through the Dx Questionnaire with the patient and record their answers in REDCap on their behalf. If patients' answers indicate a gap in communication (i.e., an answer of "No" on a question), the Research Assistant will ask for permission to follow-up within the next few days and will relay the gap in communication to the patients' care team (i.e., nurse).
Epic-integrated Quality and Safety Dashboard, currently in operational use at BWH, will be enhanced to include a new diagnostic safety column. Clinical staff will receive Training and "at-the-elbow" support by the research team upon implementation.
Diagnostic error
Data Source: Chart audit Analytic Variables: * % patients with diagnostic error * % patients with diagnostic error with actual or potential AE (i.e., harmful DE) * % patients with diagnostic error with actual or potential AE that was severe (i.e., harmful and severe DE) * % patients with diagnostic error with actual or potential AE that was preventable (i.e., harmful, severe, and preventable DE)
Time frame: 30 days (at most) from admission to the hospital
"Safe diagnosis"
Data Source: Chart audit Analytic variables: • % patients with correct diagnosis or therapy established within 24 hours of admission
Time frame: 30 days (at most) from admission to the hospital
Healthcare resource utilization
Data Source: EDW (enterprise data warehouse) Analytic variables: • % patients with ≥ 1 unscheduled ED visit or readmission
Time frame: 30 days after discharge from the hospital
Patient satisfaction
HCAPHS (the Hospital Consumer Assessment of Healthcare Providers and Systems)patient satisfaction survey: The survey is composed of 27 items: 18 substantive items that encompass critical aspects of the hospital experience (communication with doctors, communication with nurses, responsiveness of hospital staff, cleanliness of the hospital environment, quietness of the hospital environment, pain management, communication about medicines, discharge information, overall rating of hospital, and recommendation of hospital).
Time frame: 30 days after discharge from the hospital
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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