(CONCERN) Clinical Decision Support (CDS) System (NCT03911687) | Clinical Trial Compass
CompletedNot Applicable
(CONCERN) Clinical Decision Support (CDS) System
United States60,893 participantsStarted 2020-07-21
Plain-language summary
There are patients who die or have a bad outcome in the hospital and this could be prevented. Data in the nurses' notes could be used by computers to tell the rest of the care team that a patient is not doing well and that they should act more quickly. This project will build and evaluate a computer system that makes it easier for the care team to see and understand that data and act quickly to save patients. The aims of this study is to answer the questions, what is the level of provider use of the CONCERN CDS notification system (called CONCERN SMARTapp) and resulting impact on selected patient outcomes? Specifically, the study has 1) validated desired thresholds for the CONCERN CDS system and 2) integrated the CONCERN CDS system for early warning of risky patient states within CDS tools.
In this portion of the study (aim 3), the investigator will implement and evaluate the CONCERN CDS system on primary outcomes of in-hospital mortality and length of stay and secondary outcomes of cardiac arrest, unanticipated transfers to the intensive care unit, and 30-day hospital readmission rates.
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.
Study inclusion criteria for patients:
* Inpatients with a stay of at least 24 hours on one of our study units
Study exclusion criteria for patients:
* Inpatients with less than 24 hours on one of our study units
* Patients less than 18 years of age
* Hospice patients
* Did not have a hospital encounter, patients not on one of our study units.
Definition of Study Units:
A clinical unit is considered a CONCERN Study unit if it meets the following criteria:
* A general medical or surgical acute care or critical care unit
The following clinical units are NOT considered CONCERN Study units:
* Pediatric or Neonatal units
* Hospice units
* Emergency Department
* Oncology units
* Obstetrician (OB)/labor and delivery units
* Behavioral/psych units
* Observational units
* Operating room
* Pre-op
* Post-op/Post Anesthesia Care Unit (PACU)
* Same day surgical units
* Plastics units
* Virtual departments in EHR database.
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.