Improving Safety of Diagnosis and Therapy in the Inpatient Setting

  • STATUS
    Recruiting
  • End date
    Sep 30, 2021
  • participants needed
    700
  • sponsor
    Brigham and Women's Hospital
Updated on 25 January 2021
thrombosis
clot
sepsis
pneumonia
altered mental status
chest pain
cellulitis
COPD
soft tissue infection
deficiency
dyspnea
abdominal pain
confusion
delirium
chronic obstructive pulmonary disease
pulmonary disease
cough
malnutrition
asthma
obstructive lung disease
shortness of breath
venous thromboembolism
deep vein thrombosis
thromboembolism
pulmonary embolism
embolism
undernutrition
chronic obstructive pulmonary disease (copd)
venous thrombosis
deep venous thrombosis of lower extremity
infection chest
protein-calorie malnutrition

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.

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.

Details
Condition Pulmonary Disease, Chest Pain, Venous Thrombosis, Delirium, Chronic Obstructive Lung Disease, SOFT TISSUE INFECTION, Back Pain, Confusion, Hypoxia, Vomiting, Syncope, CONNECTIVE TISSUE DISEASE, Venous Thromboembolism, Nutritional marasmus, Septicemia, Failure to Thrive, Upper respiratory infection, Dyspnea, Cough, Headache, Diarrhea, Pneumonia, Pulmonary Embolism, skin infection, Cellulitis, Fever, Neck Pain, Pain, Thromboembolism, Thrombosis, Abdominal Pain, Asthenia, Asthma, Fatigue, Chronic Back Pain, Blood Clots, Allergies & Asthma, Skin Infections/Disorders, Chronic Cough, Throat and Tonsil Infections, COPD (Chronic Obstructive Pulmonary Disease), Sepsis and Septicemia, Dermatomyositis (Connective Tissue Disease), Post-Surgical Pain, Asthma (Pediatric), Recurrent Diarrhea, Pain (Pediatric), Reactive Airway Disease, Clostridium Difficile-Associated Diarrhea, Pneumonia (Pediatric), Leg Pain, Hip Pain Chronic, Connective Tissue Diseases, Lung Disease, Headaches, Soft Tissue Infections, Deep Vein Thrombosis, Mental Status Change, Electrolyte Metabolism Abnormal, chronic obstructive pulmonary disease, pneumoniae, pneumonitis, lung inflammation, breathlessness, shortness of breath, breathing difficulty, difficulty breathing, breathless, trouble breathing, respiratory difficulties, breathing difficulties, pain chest, fainting, falls out, faint, deep venous thrombosis of lower extremity, diarrhoea, loose stools, systemic infection, systemic infections, asthmatic, bronchial asthma, weakness, weak, strength loss, loss of strength, deep venous thrombosis, lower limb pain, vomit, pyrexia, hyperthermia, fevers, coughing, hypoxic, confused, disorientation, COPD, lung embolism, backpain, backache, chronic obstructive pulmonary disease (copd), growth failure, protein-calorie malnutrition, sepsis, sepsis syndrome
Treatment Diagnostic Uncertainty Educational Curriculum, Diagnostic Timeout, Patient Diagnostic (Dx) Questionnaire, Enhancements to Epic-integrated Quality & Safety Dashboard
Clinical Study IdentifierNCT04393909
SponsorBrigham and Women's Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: skin infection or Venous Thrombosis or Chest Pain or Syncope or Dyspnea or Septicemia or Chronic Obstructive Lung Disease or Failure to Thrive or Pain...?
Do you have any of these conditions: Pneumonia or backpain or protein-calorie malnutrition or Chronic Back Pain or SOFT TISSUE INFECTION or deep venous thrombosis or loose stools or disor...?
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
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