Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06695169

Conditions

Nurse's Role

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Nurse's Role

Study ID

NCT06695169

Start date

Jan 31, 2025

Status verified date

Jun, 2026

Completion date

Nov 11, 2026

Anticipated

Primary completion date

Mar 1, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

485 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Pump adoption rate [ Time Frame: 6 months ]
  • Alerts messages [ Time Frame: 6 months ]
  • Errors in documenting the volume of IV medications [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Azizeh Sowan, PhD, RN, MSN, MSDA, MBA, FAAN

210-567-5889Sowan@uthscsa.edu

Locations

University Health

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Ana Vera, PhD, RN, NPD-BC, NEA-BC

210-743-6654Ana.Vera@uhtx.com

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Integrated smart pumps
  • Integrated technology
  • Chart review

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-06-15.