DeliriumPSLL2-0NCT04393909
Improving Safety of Diagnosis and Therapy in the Inpatient Setting
A study testing Diagnostic Uncertainty Educational Curriculum, Diagnostic Timeout and Patient Diagnostic (Dx) Questionnaire in people with Delirium and Confusion, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Confusion, Mental Status Change
- What is being tested?
- Diagnostic Uncertainty Educational Curriculum, Diagnostic Timeout and Patient Diagnostic (Dx) Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- Not pregnant women, prisoners and institutionalized individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: Patient Safety Learning Laboratory: Improving Safety of Diagnosis and Therapy in the Inpatient Setting
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.
Read the 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.
- Conditions
- Delirium, Confusion, Mental Status Change, Back Pain, Hip Pain Chronic, Chest Pain
- Being tested
- Diagnostic Uncertainty Educational Curriculum, Diagnostic Timeout, Patient Diagnostic (Dx) Questionnaire, Enhancements to Epic-integrated Quality & Safety Dashboard
- Keywords
- Diagnostic errors
- Medical subject headings
- Delirium, Confusion, Back Pain, Chest Pain, Asthma, Pulmonary Disease, Chronic Obstructive, Cellulitis, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Uncertainty Educational CurriculumBehavioural
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.
Diagnostic TimeoutBehavioural
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.
Patient Diagnostic (Dx) QuestionnaireBehavioural
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).
Enhancements to Epic-integrated Quality & Safety DashboardBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients do not have access to the Patient Dx Questionnaire. Receives: Behavioral: Diagnostic Uncertainty Educational Curriculum; Behavioral: Diagnostic Timeout; Behavioral: Enhancements to Epic-integrated Quality & Safety Dashboard |
| Patient Dx Questionnaire User group | Active comparator | Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside. Receives: Behavioral: Diagnostic Uncertainty Educational Curriculum; Behavioral: Diagnostic Timeout; Behavioral: Patient Diagnostic (Dx) Questionnaire; Behavioral: Enhancements to Epic-integrated Quality & Safety Dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days (at most) from admission to the hospital
"Safe diagnosis"
Data Source: Chart audit
Analytic variables:
- % patients with correct diagnosis or therapy established within 24 hours of admission
Measured: 30 days (at most) from admission to the hospital
Secondary outcomes (2)
Healthcare resource utilization
Data Source: EDW (enterprise data warehouse)
Analytic variables:
- % patients with ≥ 1 unscheduled ED visit or readmission
Measured: 30 days after discharge from the hospital
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).
Measured: 30 days after discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Jul 2019
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Anuj K. Dalal, MD, Brigham and Women's Hospital
- Investigators
- Anuj K Dalal, MD, Principal investigator, Brigham and Women's HospitalDavid W Bates, MD, MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393909
- Sponsor's protocol ID
- 2017P001000
- Acronym
- PSLL2-0
- Status last verified
- Jul 2022
- First submitted
- 10 May 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Safety Learning Laboratory: Improving Safety of Diagnosis and Therapy in the Inpatient Setting
- ClinicalTrials.gov ID
- NCT04393909
- Acronym / sponsor ID
- PSLL2-0 / 2017P001000
- Conditions
- Delirium, Confusion, Mental Status Change, Back Pain, Hip Pain Chronic, Chest Pain
- Keywords
- Diagnostic errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Diagnostic Uncertainty Educational Curriculum, Behavioral: Diagnostic Timeout, Behavioral: Enhancements to Epic-integrated Quality & Safety DashboardPatients do not have access to the Patient Dx Questionnaire. |
| Patient Dx Questionnaire User group | Active comparator | Behavioral: Diagnostic Uncertainty Educational Curriculum, Behavioral: Diagnostic Timeout, Behavioral: Patient Diagnostic (Dx) Questionnaire, Behavioral: Enhancements to Epic-integrated Quality & Safety DashboardPatient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (1 listed)
- Not pregnant women, prisoners and institutionalized individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Uncertainty Educational CurriculumA 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. | Behavioural | Control group, Patient Dx Questionnaire User group |
| Diagnostic TimeoutA "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. | Behavioural | Control group, Patient Dx Questionnaire User group |
| Patient Diagnostic (Dx) QuestionnaireWe 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). | Behavioural | Patient Dx Questionnaire User group |
| Enhancements to Epic-integrated Quality & Safety DashboardEpic-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. | Behavioural | Control group, Patient Dx Questionnaire User group |
Primary outcome
Diagnostic error
Time frame: 30 days (at most) from admission to the hospital
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"
Time frame: 30 days (at most) from admission to the hospital
Data Source: Chart audit Analytic variables: • % patients with correct diagnosis or therapy established within 24 hours of admission
2 secondary outcomes
Healthcare resource utilization
Time frame: 30 days after discharge from the hospital
Patient satisfaction
Time frame: 30 days after discharge from the hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- PSLL 2.0 Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anuj K Dalal, MD principal investigator
Brigham and Women's Hospital
David W Bates, MD, MSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Uncertainty Educational Curriculum, Diagnostic Timeout and Patient Diagnostic (Dx) Questionnaire in people with Delirium and Confusion, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic error (time frame: 30 days (at most) from admission to the hospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.