Improving Safety of Diagnosis and Therapy in the Inpatient Setting

Not Applicable

Completed

• Conditions: Leg Pain; COPD; Soft Tissue Infections; Cough; Dyspnea; Protein-Calorie Malnutrition; Deep Vein Thrombosis; Confusion; Mental Status Change; Back Pain
• Interventions: Behavioral: Diagnostic Uncertainty Educational Curriculum; Behavioral: Diagnostic Timeout; Behavioral: Patient Diagnostic (Dx) Questionnaire; Behavioral: Enhancements to Epic-integrated Quality & Safety Dashboard

• Registration Number: NCT04393909
• Lead Sponsor: Brigham and Women's Hospital

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.

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 Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-19
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Patient Dx Questionnaire User group	Enhancements to Epic-integrated Quality & Safety Dashboard	Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
Control group	Enhancements to Epic-integrated Quality & Safety Dashboard	Patients do not have access to the Patient Dx Questionnaire.
Control group	Diagnostic Uncertainty Educational Curriculum	Patients do not have access to the Patient Dx Questionnaire.
Patient Dx Questionnaire User group	Diagnostic Timeout	Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
Control group	Diagnostic Timeout	Patients do not have access to the Patient Dx Questionnaire.
Patient Dx Questionnaire User group	Patient Diagnostic (Dx) Questionnaire	Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
Patient Dx Questionnaire User group	Diagnostic Uncertainty Educational Curriculum	Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.

Primary Outcome Measures

Name	Time	Method
Diagnostic error	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)
"Safe diagnosis"	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 Outcome Measures

Name	Time	Method
Healthcare resource utilization	30 days after discharge from the hospital	Data Source: EDW (enterprise data warehouse); Analytic variables: • % patients with ≥ 1 unscheduled ED visit or readmission
Patient satisfaction	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).

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States