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

NCT06695169 | Recruiting

• 1 other identifier: STUDY00000585
• Study Type: observational
• Target: 659
• Locations: 1 country
• Sites: 1

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

Keywords

Integrated smart pumps; Integrated technology; Chart review

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4 months

Secondary Outcomes (3)

• Usability of the Pumps

  9 months

• Nurse perception of the usability of the integrated smart pump technology

  6 months

• Factors that facilitate or hinder technology adoption

  11 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

University Health

San Antonio, Texas, 78229, United States

RECRUITING

Study Officials

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

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

210-567-5889; Sowan@uthscsa.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: January 31, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: The IPD will be available starting 6 months after the publication of the study results. The data will remain available for a period of 5 years from the end date of data collection.
• Access Criteria: The de-identified IPD will be made available to researchers upon reasonable request for purposes of secondary analysis or meta-analysis only. Access will be granted to qualified researchers affiliated with academic, non-profit, or government institutions who provide a detailed research proposal outlining their objectives and methods. Researchers will need to sign a data use agreement that outlines the terms of access, including proper data handling, acknowledgment of the original study, and compliance with ethical standards. The data will be shared electronically via a secure data-sharing platform, and access will be time-limited based on the approved use. For the URL below, No dedicated webpage is available at this time. For more information about the IPD sharing plan, interested researchers may contact \[Azizeh Sowan, Sowan@uthscsa.edu and Ana Vera, ana.vera@uhtx.com\]

Locations

US (1)