Clinical trial NCT04393909: Improving Safety of Diagnosis and Therapy in the Inpatient Setting
Official title: Patient Safety Learning Laboratory: Improving Safety of Diagnosis and Therapy in the Inpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Confusion
Mental Status Change
Back Pain
Hip Pain Chronic
Chest Pain
Asthma
COPD
Cellulitis
Soft Tissue Infections
Cough
Deep Vein Thrombosis
Pulmonary Embolism
Venous Thromboembolism
Dyspnea
Electrolyte Metabolism Abnormal
Fever
Failure to Thrive
Weakness
Protein-Calorie Malnutrition
Headache
Neck Pain
Hypoxia
Pneumonia
Sepsis
Syncope
Vomiting
Diarrhea
Leg Pain
Abdominal Pain
Keywords: Diagnostic errors
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-05-19
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: We will conduct a pre-post interrupted time series design study in which we compare the relative effectiveness of the intervention over pre-post intervention for enrolled patients for our main outcomes.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic error
timeFrame: 30 days (at most) from admission to the hospital
measure: "Safe diagnosis"
timeFrame: 30 days (at most) from admission to the hospital
Secondary outcomes:
measure: Healthcare resource utilization
timeFrame: 30 days after discharge from the hospital
measure: Patient satisfaction
timeFrame: 30 days after discharge from the hospital
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Anuj K Dalal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: David W Bates, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: