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

NCT ID: NCT06695169

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

659 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-11-30

Brief Summary

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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

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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

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Nurse's Role

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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University Health

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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

Role: CONTACT

210-567-5889

Facility Contacts

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

Role: primary

210-743-6654

Other Identifiers

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STUDY00000585

Identifier Type: -

Identifier Source: org_study_id

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