Improving Safety of Diagnosis and Therapy in the Inpatient Setting (PSLL2-0)

Patient Safety Learning Laboratory: 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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Sepsis; Delirium; Confusion; Hip Pain Chronic; Hypoxia; Back Pain; Vomiting; Abdominal Pain; Diarrhea; Cough; Asthma; Chest Pain; Neck Pain; Fever; Cellulitis; Syncope; Headache; Deep Vein Thrombosis; Venous Thromboembolism; Soft Tissue Infections; Failure to Thrive; COPD; Pulmonary Embolism; Dyspnea; Leg Pain; Mental Status Change; Electrolyte Metabolism Abnormal; Weakness; Protein-Calorie Malnutrition
• Intervention / Treatment: Behavioral: Diagnostic Uncertainty Educational Curriculum; Behavioral: Diagnostic Timeout; Behavioral: Enhancements to Epic-integrated Quality & Safety Dashboard; Behavioral: Patient Diagnostic (Dx) Questionnaire

Detailed Description

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:

1. 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.
2. Design, develop, and iteratively refine intervention components using lessons learned from problem analysis and a participatory process that involves patients, clinicians, and institutional stakeholders.
3. 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.

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Patients do not have access to the Patient Dx Questionnaire.	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: 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.
Active Comparator: Patient Dx Questionnaire User group; Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.	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: 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.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• PSLL 2.0 Study Website

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Diagnostic errors
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Inflammation; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Signs and Symptoms, Digestive; Nutrition Disorders; Connective Tissue Diseases; Embolism and Thrombosis; Signs and Symptoms, Respiratory; Skin Diseases, Infectious; Deficiency Diseases; Suppuration; Unconsciousness; Consciousness Disorders; Protein Deficiency; Vomiting; Embolism; Diarrhea; Chest Pain; Abdominal Pain; Neck Pain; Cellulitis; Headache; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Malnutrition; Syncope; Soft Tissue Infections; Hypoxia; Failure to Thrive; Confusion; Pulmonary Embolism; Dyspnea; Protein-Energy Malnutrition
• Other Study ID Numbers: 2017P001000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No