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RecruitingNCT06695169Updated Jun 15, 2026

Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units

An observational study in Nurse's Role, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 1 site in United States. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by The University of Texas Health Science Center at San Antonio · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
485
Ages
20 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Nurse's Role

Keywords

  • Integrated smart pumps
  • Integrated technology
  • Chart review
03

In context

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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 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.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
485 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 4 months

Secondary outcomes

  1. 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).

    Time frame: 9 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 11 months

07

Study locations

1 of 1 sites recruiting
  • University Health
    San Antonio, Texas 78229, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06695169
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Baxter Healthcare Corporation
Responsible party
Sponsor
First posted
Nov 19, 2024
Start date
Jan 31, 2025
Primary completion
Mar 1, 2026
Completion
Nov 11, 2026 (estimated)
Last update
Jun 15, 2026

Study contacts

Azizeh Sowan, PhD, RN, MSN, MSDA, MBA, FAAN
Contact
Sowan@uthscsa.edu
210-567-5889
Azizeh Sowan, PhD, RN, MSN, MSDA, MBA, FAAN
principal investigator · The University of Texas Health Science Center at San Antonio

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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