Asthma Clinical Trial
— PSLL2-0Official title:
Patient Safety Learning Laboratory: Improving Safety of Diagnosis and Therapy in the Inpatient Setting
Verified date | July 2022 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 700 |
Est. completion date | December 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | "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 | 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 | |
Secondary | 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 |
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