Improving Safety of Diagnosis and Therapy in the Inpatient Setting (PSLL2-0)
Primary Purpose
Delirium, Confusion, Mental Status Change
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic Uncertainty Educational Curriculum
Diagnostic Timeout
Patient Diagnostic (Dx) Questionnaire
Enhancements to Epic-integrated Quality & Safety Dashboard
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring Diagnostic errors
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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control group
Patient Dx Questionnaire User group
Arm Description
Patients do not have access to the Patient Dx Questionnaire.
Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
Outcomes
Primary Outcome Measures
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)
"Safe diagnosis"
Data Source: Chart audit
Analytic variables:
• % patients with correct diagnosis or therapy established within 24 hours of admission
Secondary Outcome Measures
Healthcare resource utilization
Data Source: EDW (enterprise data warehouse)
Analytic variables:
• % patients with ≥ 1 unscheduled ED visit or readmission
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).
Full Information
NCT ID
NCT04393909
First Posted
May 10, 2020
Last Updated
July 21, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT04393909
Brief Title
Improving Safety of Diagnosis and Therapy in the Inpatient Setting
Acronym
PSLL2-0
Official Title
Patient Safety Learning Laboratory: Improving Safety of Diagnosis and Therapy in the Inpatient Setting
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
Design, develop, and iteratively refine intervention components using lessons learned from problem analysis and a participatory process that involves patients, clinicians, and institutional stakeholders.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients do not have access to the Patient Dx Questionnaire.
Arm Title
Patient Dx Questionnaire User group
Arm Type
Active Comparator
Arm Description
Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
Intervention Type
Behavioral
Intervention Name(s)
Diagnostic Uncertainty Educational Curriculum
Intervention Description
A Diagnostic Uncertainty Educational Curriculum will consist of an interactive, one-hour "teach-the-teacher" workshop delivered to resident-attending pairs early on during their inpatient medicine rotation. During the workshop, we will discuss the motivation behind teaching diagnostic uncertainty, review factors that may predict risk of diagnostic error during hospitalization, introduce the framework. Each resident-attending pair will work through a case-based exercise focused on managing learners' diagnostic uncertainty during rounds. Our research team will also conduct Training for clinical staff working on intervention units and will provide "at-the-elbow" support during the intervention period of the main trial.
Intervention Type
Behavioral
Intervention Name(s)
Diagnostic Timeout
Intervention Description
A "Diagnostic Timeout" is a structured "pocket guide" that clinicians may use to address uncertainty in a step-wise approach for patients who have risk factors for diagnostic error. This tool can be used during or after clinical rounds, inside or outside of a patient's room if the patient is agreeable. The "Diagnostic Timeout" will be introduced as part of the Diagnostic Uncertainty Educational Curriculum as well as Training.
Intervention Type
Behavioral
Intervention Name(s)
Patient Diagnostic (Dx) Questionnaire
Intervention Description
We will administer a survey, the Dx Questionnaire, to patients which asks a series of questions on communication regarding diagnosis with the care team. Patients admitted to inpatient units within the prior 24 hours will be approached after asking the patient's nurse to determine whether it is the appropriate time to approach for enrollment. Upon explaining the objectives of the survey and obtaining verbal informed consent, patients will be asked to complete the Dx Questionnaire via REDCap on an iPad. Alternatively, the research assistant administering the survey will go through the Dx Questionnaire with the patient and record their answers in REDCap on their behalf. If patients' answers indicate a gap in communication (i.e., an answer of "No" on a question), the Research Assistant will ask for permission to follow-up within the next few days and will relay the gap in communication to the patients' care team (i.e., nurse).
Intervention Type
Behavioral
Intervention Name(s)
Enhancements to Epic-integrated Quality & Safety Dashboard
Intervention Description
Epic-integrated Quality and Safety Dashboard, currently in operational use at BWH, will be enhanced to include a new diagnostic safety column. Clinical staff will receive Training and "at-the-elbow" support by the research team upon implementation.
Primary Outcome Measure Information:
Title
Diagnostic error
Description
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)
Time Frame
30 days (at most) from admission to the hospital
Title
"Safe diagnosis"
Description
Data Source: Chart audit
Analytic variables:
• % patients with correct diagnosis or therapy established within 24 hours of admission
Time Frame
30 days (at most) from admission to the hospital
Secondary Outcome Measure Information:
Title
Healthcare resource utilization
Description
Data Source: EDW (enterprise data warehouse)
Analytic variables:
• % patients with ≥ 1 unscheduled ED visit or readmission
Time Frame
30 days after discharge from the hospital
Title
Patient satisfaction
Description
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).
Time Frame
30 days after discharge from the hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anuj K Dalal, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David W Bates, MD, MSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://psll.bwh.harvard.edu/
Description
PSLL 2.0 Study Website
Learn more about this trial
Improving Safety of Diagnosis and Therapy in the Inpatient Setting
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