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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Patients do not have access to the Patient Dx Questionnaire. |
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| Patient Dx Questionnaire User group | Active Comparator | Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Uncertainty Educational Curriculum | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic error | Data Source: Chart audit Analytic Variables:
| 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 | 30 days (at most) from admission to the hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare resource utilization | Data Source: EDW (enterprise data warehouse) Analytic variables: • % patients with ≥ 1 unscheduled ED visit or readmission | 30 days after discharge from the hospital |
| Patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anuj K Dalal, MD | Brigham and Women's Hospital | Principal Investigator |
| David W Bates, MD, MSc | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
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| Label | URL |
|---|---|
| PSLL 2.0 Study Website | View source |
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We will conduct a pre-post interrupted time series design study in which we compare the relative effectiveness of the intervention over pre-post intervention for enrolled patients for our main outcomes.
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| Diagnostic Timeout | Behavioral | 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. |
|
| Patient Diagnostic (Dx) Questionnaire | Behavioral | 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). |
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| Enhancements to Epic-integrated Quality & Safety Dashboard | Behavioral | 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. |
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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).
| 30 days after discharge from the hospital |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D001416 | Back Pain |
| D002637 | Chest Pain |
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002481 | Cellulitis |
| D018461 | Soft Tissue Infections |
| D003371 | Cough |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D054556 | Venous Thromboembolism |
| D004417 | Dyspnea |
| D005334 | Fever |
| D005183 | Failure to Thrive |
| D001247 | Asthenia |
| D011502 | Protein-Energy Malnutrition |
| D006261 | Headache |
| D019547 | Neck Pain |
| D000860 | Hypoxia |
| D011014 | Pneumonia |
| D018805 | Sepsis |
| D013575 | Syncope |
| D014839 | Vomiting |
| D003967 | Diarrhea |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004617 | Embolism |
| D013923 | Thromboembolism |
| D001832 | Body Temperature Changes |
| D011488 | Protein Deficiency |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012141 | Respiratory Tract Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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