Improving Safety of Diagnosis and Therapy in the Inpatient Setting
NCT04393909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700
Last updated 2022-07-26
Summary
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.
Conditions
- Delirium
- Confusion
- Mental Status Change
- Back Pain
- Hip Pain Chronic
- Chest Pain
- Asthma
- COPD
- Cellulitis
- Soft Tissue Infections
- Cough
- Deep Vein Thrombosis
- Pulmonary Embolism
- Venous Thromboembolism
- Dyspnea
- Electrolyte Metabolism Abnormal
- Fever
- Failure to Thrive
- Weakness
- Protein-Calorie Malnutrition
- Headache
- Neck Pain
- Hypoxia
- Pneumonia
- Sepsis
- Syncope
- Vomiting
- Diarrhea
- Leg Pain
- Abdominal Pain
Interventions
- BEHAVIORAL
-
Diagnostic Uncertainty Educational Curriculum
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.
- BEHAVIORAL
-
Diagnostic Timeout
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.
- BEHAVIORAL
-
Patient Diagnostic (Dx) Questionnaire
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).
- BEHAVIORAL
-
Enhancements to Epic-integrated Quality & Safety Dashboard
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.
Sponsors & Collaborators
-
Agency for Healthcare Research and Quality (AHRQ)
collaborator FED -
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Anuj K Dalal, MD · Brigham and Women's Hospital
-
David W Bates, MD, MSc · Brigham and Women's Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-01
- Primary Completion
- 2021-09-30
- Completion
- 2021-12-30
Countries
- United States
Study Locations
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