Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units (NCT06695169) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units
United States485 participantsStarted 2025-01-31
Plain-language summary
This study looks at the effects of using "smart pumps" that connect with the Electronic Health Record (EHR) in 8 adult ICU units.
We will interview nurses and healthcare team members to learn about any challenges with this technology.
All nurses in these units will be invited to complete a survey on how easy the technology is to use.
Some nurses will practice giving medications to "mannequins" in a simulation lab to see how they work with the pumps.
We will also look at existing data to find out how many nurses use the technology and what types of alerts or errors come up.
Finally, we will review patient charts to see if using the technology has increased or decreased errors in recording IV medication amounts.
Who can participate
Age range
20 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:
* Research Aims 1 (adoption rate) and 2 (frequency and types of alerts and programming error ). We will include all IV medications and fluids delivered via smart infusion pumps within the past 6 months. We anticipate the dataset to include more than 180,000 of medications and fluid administration events.
* Research Aim 3 (documentation errors ). We will select 200 IV medications that were administered with solutions using chart audit. To be included, the selected IV medications should be diluted with at least 100 ml solution. The choice of the 100 ml cutoff point was based on it being the minimum volume for the majority of IV medication administrations.
* Research Aims 4, 5, 6, and 7 (usability of the technology, nurse perception, predictors of nurse perception, nurse experience with technology). Eligibility criteria will be confined to registered nurses with at least an associate degree in nursing.
* Research Aim 8 (multidisciplinary team experience with technology). The inclusion criteria for the group of multidisciplinary representatives encompass participation in pump implementation and pumps-related quality improvement initiatives.
Exclusion Criteria:
* Research Aims 1 and 2. Bolus medications will be excluded due to the distinct workflow associated with their administration.
* Research Aim 3. Medications with solution volumes lower than 100 ml will be excluded.
* Research Aims 4, 5, 6, and 7. Licensed vocational nurses (LVN) and licensed practical…
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.
1This trial seems to focus on nurse workflows and smart pump technology rather than testing a treatment — does participating in this study actually change the medications or care I'd receive, or does it mainly involve observation of how nurses use these IV pump systems?
2Since the study is measuring how often errors occur in documenting IV medication volumes, should I be asking the nursing staff to double-check my IV medication records more carefully during my stay, or is that kind of oversight already built into the study?
3The trial is listed as 'Phase NA,' which I understand means it's evaluating a technology or process rather than a new drug — can you explain what risks, if any, there might be for me as a patient in one of these eight care units where this smart pump system is being tested?
4If the smart pump and electronic health record integration is still being evaluated for adoption and alert accuracy, what happens if a medication alert is missed or the system doesn't work as expected during my care — is there a backup process in place?
5Would being in one of these monitored units affect my standard care plan in any way, and is there anything I should know or consent to before being included in this kind of technology evaluation study?
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
Pump adoption rate
Timeframe: 6 months
2
Alerts messages
Timeframe: 6 months
3
Errors in documenting the volume of IV medications
Timeframe: 4 months
Trial details
NCT IDNCT06695169
SponsorThe University of Texas Health Science Center at San Antonio