Clinical trial NCT06695169: Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units
Official title: Comprehensive Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units: A Mixed Method Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nurse's Role
Keywords: Integrated smart pumps
Integrated technology
Chart review
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2024-11-19
Enrollment: 659
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pump adoption rate
timeFrame: 6 months
measure: Alerts messages
timeFrame: 6 months
measure: Errors in documenting the volume of IV medications
timeFrame: 4 months
Secondary outcomes:
measure: Usability of the Pumps
timeFrame: 9 months
measure: Nurse perception of the usability of the integrated smart pump technology
timeFrame: 6 months
measure: Factors that facilitate or hinder technology adoption
timeFrame: 11 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Health
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Azizeh Sowan, PhD, RN, MSN, MSDA, MBA, FAAN
role: PRINCIPAL_INVESTIGATOR
References: