Nurse's RoleNCT06695169
Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units
An observational study of Nurse's Role, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Nurse's Role
- Type of treatment
- Injection or infusion
- How many people
- 485 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2025to 11 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nurses who use integrated smart pump technology to administer IV drugs and fluids will take part in interviews, simulations, and surveys. Additionally, a sample of multidisciplinary team members involved in the implementation of smart pumps in 2018, the integration of smart pumps with the electronic health record in 2020, or past/current pump-related quality improvement initiatives will participate in interviews.
Who may be able to join
- 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.
Who cannot join
- 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 nurses (LPN) will be excluded due to their non-involvement in IV medication administration. Additionally, and for Research Aim # 7, the group of 48 nurses who will engage in the usability testing will not be part of the focus group interviews to ensure a broader participation among nurses.
- Research Aim 8: Stakeholders from the different hospital's departments and councils (e.g., nursing, biomedical engineering, pharmacy, risk and management, technology committees, etc.) who were not part of the implementation process of infusion pumps in 2018 and 2020 or are not involved in continuous quality initiatives related to infusion pump adoption and quality measures tracking will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Health
San Antonio, Texas, 78229
Ana Vera, PhD, RN, NPD-BC, NEA-BC, 210-743-6654, Ana.Vera@uhtx.com
About this study
Official title: Comprehensive Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units: A Mixed Method Study
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.
Read more
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.
Read the detailed description
This mixed-methods design study focuses on understanding the complexity and consequences of implementing the integrated smart pumps-EHR technology in 8 adult acute and intensive care units (ICUs) using a comprehensive evaluation approach. The evaluation will include (1) analyzing use manifestations in terms of nurse adoption, alarms, alerts, and error messages associated with technology use, (2) examining the usability of the integrated technology, and (3) identifying influential factors that facilitate or hinder technology adoption.
- Conditions
- Nurse's Role
- Keywords
- Integrated smart pumps, Integrated technology, Chart review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nurses in ICU or Acute Care who administer medications using Smart infusion pumps | (A) Nurses from 8 acute and intensive care units (659 nurses total) will be invited to complete a survey about using the pumps. (B) Of these 659 nurses, 48 will join focus groups to share detailed thoughts on pump use. (C) Another 48 nurses will practice using the pumps in a simulation setting. The study will also review 200 patient records to check for any differences in documentation errors of IV medication volumes when using pump-EHR integration versus manually programming the pumps. Additionally, the study will analyze pump data from the last 6 months to see how often the technology is used and what types of alerts and programming errors occur. Furthermore, 20 healthcare team members will participate in interviews to understand the barriers and facilitators of technology use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pump adoption rate
Data from the pumps over the past 6 months will be reviewed and analyzed to understand how often nurses use the integrated pump-EHR (or electronic health record) technology versus manually programming the pumps when administering medications. Z-test will be used to test the difference in percentage in adoption rate.
Measured: 6 months
Alerts messages
Data from the pumps over the past 6 months will be reviewed to examine the difference in frequency of alert messages (including programming error messages) generated when manually programming the pump versus using the pump-EHR integrated technology. Data will be analyzed using chi-square.
Measured: 6 months
Errors in documenting the volume of IV medications
200 patient charts will be reviewed to compare documentation errors in IV medication volumes when using pump-EHR integration versus manual pump programming.
Measured: 4 months
Secondary outcomes (3)
Usability of the Pumps
During observations of 48 nurses' interactions with the pumps in a simulated environment, we will identify the navigation paths nurses follow to program the pumps (through recording of nurse-pump navigation), examine usability errors (through recording of nurse-pump navigation), record the time taken by nurses to navigate the pumps to administer IV medications (through recording of nurse-pump navigation), assess perceived workload during pump navigation (using a survey), and assess nurse experience and perceived challenges during task completion (using the debriefing session).
Measured: 9 months
Nurse perception of the usability of the integrated smart pump technology
We will send a survey to all nurses who work in the 8 acute and intensive care units to understand their perceptions about the technology. Descriptive statistics will be used to analyze the results.
Measured: 6 months
Factors that facilitate or hinder technology adoption
We will use semi-structured interviews to explore bedside nurses' experiences with the integrated smart pump-EHR technology, including any challenges they face.
Additionally, we will interview a multidisciplinary healthcare team to understand the organizational and contextual factors that help or hinder the adoption of this technology.
All interviews will be transcribed by professionals from Rev, a transcription vendor. Data will be entered into nVivo software. The 4-stage content analysis methodology by Bengtsson (2016) will be used to categorize narrative data into themes.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start31 Jan 2025
- Primary completion1 Mar 2026
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 485 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Azizeh Sowan, PhD, RN, MSN, MSDA, MBA, FAAN, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695169
- Sponsor's protocol ID
- STUDY00000585
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The specific individual participant data (IPD) that will be shared will be limited to quantitative data. These will include the de-identified responses to the survey, the log data retrieved from smart pumps, and the de-identified results of the chart audit.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units: A Mixed Method Study
- ClinicalTrials.gov ID
- NCT06695169
- Acronym / sponsor ID
- STUDY00000585
- Conditions
- Nurse's Role
- Keywords
- Integrated smart pumps, Integrated technology, Chart review
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 485 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 19 Nov 2024 (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.
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.
Detailed description
This mixed-methods design study focuses on understanding the complexity and consequences of implementing the integrated smart pumps-EHR technology in 8 adult acute and intensive care units (ICUs) using a comprehensive evaluation approach. The evaluation will include (1) analyzing use manifestations in terms of nurse adoption, alarms, alerts, and error messages associated with technology use, (2) examining the usability of the integrated technology, and (3) identifying influential factors that facilitate or hinder technology adoption.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurses in ICU or Acute Care who administer medications using Smart infusion pumps | – | –(A) Nurses from 8 acute and intensive care units (659 nurses total) will be invited to complete a survey about using the pumps. (B) Of these 659 nurses, 48 will join focus groups to share detailed thoughts on pump use. (C) Another 48 nurses will practice using the pumps in a simulation setting. The study will also review 200 patient records to check for any differences in documentation errors of IV medication volumes when using pump-EHR integration versus manually programming the pumps. Additionally, the study will analyze pump data from the last 6 months to see how often the technology is used and what types of alerts and programming errors occur. Furthermore, 20 healthcare team members will participate in interviews to understand the barriers and facilitators of technology use. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nurses who use integrated smart pump technology to administer IV drugs and fluids will take part in interviews, simulations, and surveys. Additionally, a sample of multidisciplinary team members involved in the implementation of smart pumps in 2018, the integration of smart pumps with the electronic health record in 2020, or past/current pump-related quality improvement initiatives will participate in interviews.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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 nurses (LPN) will be excluded due to their non-involvement in IV medication administration. Additionally, and for Research Aim # 7, the group of 48 nurses who will engage in the usability testing will not be part of the focus group interviews to ensure a broader participation among nurses.
- Research Aim 8: Stakeholders from the different hospital's departments and councils (e.g., nursing, biomedical engineering, pharmacy, risk and management, technology committees, etc.) who were not part of the implementation process of infusion pumps in 2018 and 2020 or are not involved in continuous quality initiatives related to infusion pump adoption and quality measures tracking will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pump adoption rate
Time frame: 6 months
Data from the pumps over the past 6 months will be reviewed and analyzed to understand how often nurses use the integrated pump-EHR (or electronic health record) technology versus manually programming the pumps when administering medications. Z-test will be used to test the difference in percentage in adoption rate.
Alerts messages
Time frame: 6 months
Data from the pumps over the past 6 months will be reviewed to examine the difference in frequency of alert messages (including programming error messages) generated when manually programming the pump versus using the pump-EHR integrated technology. Data will be analyzed using chi-square.
Errors in documenting the volume of IV medications
Time frame: 4 months
200 patient charts will be reviewed to compare documentation errors in IV medication volumes when using pump-EHR integration versus manual pump programming.
3 secondary outcomes
Usability of the Pumps
Time frame: 9 months
Nurse perception of the usability of the integrated smart pump technology
Time frame: 6 months
Factors that facilitate or hinder technology adoption
Time frame: 11 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Yes. The specific individual participant data (IPD) that will be shared will be limited to quantitative data. These will include the de-identified responses to the survey, the log data retrieved from smart pumps, and the de-identified results of the chart audit.
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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.
Azizeh Sowan, PhD, RN, MSN, MSDA, MBA, FAAN principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse's Role, run by The University of Texas Health Science Center at San Antonio 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azizeh Sowan, PhD, RN, MSN, MSDA, MBA, FAAN (210-567-5889, Sowan@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pump adoption rate (time frame: 6 months). The study lists 3 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 15 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.