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NCT Number: NCT04393909

Improving Safety of Diagnosis and Therapy in the Inpatient Setting

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.

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Key information

Conditions

Delirium Abdominal Pain Asthenia Asthma Back Pain Body Temperature Changes Bronchial Diseases COPD Cardiovascular Diseases Cellulitis Chest Pain Chronic Disease Confusion Connective Tissue Diseases Consciousness Disorders Cough Deep Vein Thrombosis Deficiency Diseases Diarrhea Disease Attributes Dyspnea Electrolyte Metabolism Abnormal Embolism Embolism and Thrombosis Failure to Thrive Fever Headache Hip Pain Chronic Hypersensitivity Hypersensitivity, Immediate Hypoxia Immune System Diseases Infections Inflammation Leg Pain Lung Diseases Lung Diseases, Obstructive Malnutrition Mental Disorders Mental Status Change Neck Pain Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Protein Deficiency Protein-Calorie Malnutrition Protein-Energy Malnutrition Pulmonary Disease, Chronic Obstructive Pulmonary Embolism Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Sepsis Signs and Symptoms Signs and Symptoms, Digestive Signs and Symptoms, Respiratory Skin Diseases, Infectious Skin and Connective Tissue Diseases Soft Tissue Infections Suppuration Syncope Systemic Inflammatory Response Syndrome Thromboembolism Thrombosis Unconsciousness Vascular Diseases Venous Thromboembolism Venous Thrombosis Vomiting Weakness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

About this study

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:

  • Analyze the problem of diagnostic error over the acute episode of care, identifying system and cognitive factors for a set of morbid, costly common conditions and undifferentiated symptoms by using system engineering and human factors methods, as well as electronic health record and administrative data review.
  • Design, develop, and iteratively refine intervention components using lessons learned from problem analysis and a participatory process that involves patients, clinicians, and institutional stakeholders.
  • Implement an intervention for patient and clinician subjects on general medicine units. Using a pre-post, interrupted time series study design, the investigators will evaluate the effect of the intervention primarily on diagnostic and therapeutic errors. The investigators will use mixed methods to understand barriers and facilitators of implementation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Sepsis
  • Other conditions typical of general medicine patients

Exclusion criteria

  • Not pregnant women, prisoners and institutionalized individuals

Treatment and study plan

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.

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).

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.

Primary outcomes

  1. Diagnostic error

    Time frame: 30 days (at most) from admission to the hospital

    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)

  2. "Safe diagnosis"

    Time frame: 30 days (at most) from admission to the hospital

    Data Source: Chart audit

    Analytic variables:

    • % patients with correct diagnosis or therapy established within 24 hours of admission

Secondary outcomes

  1. Healthcare resource utilization

    Time frame: 30 days after discharge from the hospital

    Data Source: EDW (enterprise data warehouse)

    Analytic variables:

    • % patients with ≥ 1 unscheduled ED visit or readmission

  2. Patient satisfaction

    Time frame: 30 days after discharge from the hospital

    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).

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Patient Safety Learning Laboratory: Improving Safety of Diagnosis and Therapy in the Inpatient Setting

Acronym: PSLL2-0

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 19, 2020
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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