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Recruiting NCT06695169

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

Observational Nurse's Role

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Nurse's Role. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comprehensive Evaluation of the Integrated Smart Pump-EHR Technology in Eight Adult Acute and Intensive Care Units: A Mixed Method Study

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Usability of the Pumps [Time frame: 9 months]
  • Nurse perception of the usability of the integrated smart pump technology [Time frame: 6 months]
  • Factors that facilitate or hinder technology adoption [Time frame: 11 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • University Health — San Antonio

Identifiers

NCT: NCT06695169 · STUDY00000585

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗