Improving Safety of Diagnosis and Therapy in the Inpatient Setting

NCT04393909 | Completed

• 1 other identifier: 2017P001000
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diagnostic errors

Outcome Measures

Primary Outcomes (2)

• 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)

  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

Secondary Outcomes (2)

• Healthcare resource utilization

  30 days after discharge from the hospital

• Patient satisfaction

  30 days after discharge from the hospital

Study Arms (2)

Control group

ACTIVE COMPARATOR

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 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.

Behavioral: Diagnostic Uncertainty Educational Curriculum; Behavioral: Diagnostic Timeout; Behavioral: Patient Diagnostic (Dx) Questionnaire; Behavioral: Enhancements to Epic-integrated Quality & Safety Dashboard

Interventions

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.

Control group; Patient Dx Questionnaire User group

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.

Control group; Patient Dx Questionnaire User group

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).

Patient Dx Questionnaire User group

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.

Control group; Patient Dx Questionnaire User group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Adult patients admitted to General Medicine Services at Brigham and Women's Hospital during the 21-months study data collection period
• English speakers
• Patients who were diagnosed with any of the following conditions and symptoms upon admission:
• Abdominal pain
• Altered mental status/ delirium / confusion
• Asthma / chronic obstructive pulmonary disease (COPD)
• Cellulitis / soft tissue infection
• Chest pain
• Cough
• Deep vein thrombosis / pulmonary embolism / venous thromboembolism
• Dyspnea / short of breath
• Failure to thrive
• Pneumonia
• Protein-calorie malnutrition

You may not qualify if:

• Not pregnant women, prisoners and institutionalized individuals

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Related Links

• PSLL 2.0 Study Website

MeSH Terms

Conditions

Delirium; Confusion; Back Pain; Chest Pain; Asthma; Pulmonary Disease, Chronic Obstructive; Cellulitis; Soft Tissue Infections; Cough; Venous Thrombosis; Pulmonary Embolism; Venous Thromboembolism; Dyspnea; Fever; Failure to Thrive; Asthenia; Protein-Energy Malnutrition; Headache; Neck Pain; Hypoxia; Pneumonia; Sepsis; Syncope; Vomiting; Diarrhea; Abdominal Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Respiration Disorders; Signs and Symptoms, Respiratory; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Embolism; Thromboembolism; Body Temperature Changes; Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Respiratory Tract Infections; Systemic Inflammatory Response Syndrome; Unconsciousness; Consciousness Disorders; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anuj K Dalal, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• David W Bates, MD, MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 19, 2020
• Study Start: July 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)