Improving Safety of Diagnosis and Therapy in the Inpatient Setting (NCT04393909) | Clinical Trial Compass
CompletedNot Applicable
Improving Safety of Diagnosis and Therapy in the Inpatient Setting
United States700 participantsStarted 2019-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic error
Timeframe: 30 days (at most) from admission to the hospital
2
"Safe diagnosis"
Timeframe: 30 days (at most) from admission to the hospital