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

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Vomiting
Cellulitis
Leg Pain
Mental Status Change
Failure to Thrive
Protein-Calorie Malnutrition
Dyspnea
Diarrhea
Hypoxia
Pneumonia
COPD
Fever
Venous Thromboembolism
Back Pain
Weakness
Electrolyte Metabolism Abnormal
Cough
Chest Pain
Hip Pain Chronic
Soft Tissue Infections
Neck Pain
Confusion
Headache
Sepsis
Pulmonary Embolism
Syncope
Asthma
Delirium
Deep Vein Thrombosis
Abdominal Pain

Treatments

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

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04393909
2017P001000

Details and patient eligibility

About

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.

Full 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.

Enrollment

700 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

700 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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