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Completed

NCT Number: NCT06245044

Preventing Medication Dispensing Errors in Pharmacy Practice With Interpretable Machine Intelligence

Pharmacists currently perform an independent double-check to identify drug-selection errors before they can reach the patient. However, the use of machine intelligence (MI) to support this cognitive decision-making work by pharmacists does not exist in practice. This research is being conducted to examine the effectiveness of the timing of machine intelligence (MI) advice on to determine if it results in lower task time, increased accuracy, and increased trust in the MI.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

Pharmacists currently perform an independent double-check currently to identify drug-selection errors before they can reach the patient. However, the use of machine intelligence (MI) to support this cognitive decision-making work by pharmacists does not exist in practice. Instead, pharmacists rely solely on reference images of the medication which they can compare to the prescription vial contents. Previous research has shown that decision support systems can effectively improve healthcare delivery efficiency and accuracy, while preventing adverse drug events. However, little is known about how MI technologies impact pharmacists' work performance and cognitive demand.

To facilitate the long-term symbiotic relationship between the pharmacists and the MI system, proper trust needs to be established. While trust has been identified as the central factor for effective human-machine teaming, issues arise when humans place unjustified trust in automated technologies do not place enough trust in them. Over trust in automation can lead to complacency and automation bias. For instance, the pharmacists may rely on the MI system to the extent that they blindly accept any recommendation by the system. Under trust can result in pharmacist disuse and potential abandonment of the MI system.

Furthermore, little is known about the timing of the MI advice on pharmacists' work performance. For example, showing the MI's advice while the pharmacist is performing the medication verification task may yield different results than showing the MI's advice after the pharmacist made their decision.

The study investigators have developed a MI system for medication images classification. The objective of this study is to examine the effectiveness of the timing of MI advice to determine if it results in lower task time, increased accuracy, and increased trust in the MI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Licensed pharmacist in the United States
  • Age 18 years and older at screening
  • PC/Laptop with Microsoft Windows 10 or Mac (Macbook, iMac) with MacOS with Google Chrome, Edge, Opera, Safari, or Firefox web browser installed on the device
  • Screen resolution of 1024x968 pixels or more
  • A laptop integrated webcam or USB webcam is also required for the eye tracking purpose.

Exclusion criteria

  • Participated in Wave 1 or Wave 2
  • Eyeglasses
  • Uncorrected cataracts, intraocular implants, glaucoma, or permanently dilated pupil
  • Require a screen reader/magnifier or other assistive technology to use the computer
  • Eye movement or alignment abnormalities (lazy eye, strabismus, nystagmus)

Treatment and study plan

No MI Help

Behavioral

Participants will complete the medication verification task without any MI help

Scenario #1

Behavioral

Participants will receive MI in the form of a pop-up message if their decision differs from the MI's determination.

Scenario #2

Behavioral

MI help will be displayed concurrently with the filled and reference images.

Primary outcomes

  1. Reaction Time

    Time frame: Throughout the verification task

    Difference in task time measured by the number of seconds from starting the task to accepting or rejecting a medication image

  2. Decision Accuracy

    Time frame: Throughout the verification task

    Difference in detection rate measured by the number of medication verification errors across all participants in the Arm/Group.

  3. Trust Change

    Time frame: After every trial in Scenarios 1 and 2

    Participants will complete 100 mock medication verification trials in each of the study arms (i.e., Scenario 1, Scenario 2, and No Help). After each trial in Scenario 1 and Scenario 2, participants will use a visual analog scale (VAS) to respond to the question: "How much do you trust the AI advice?" The endpoints of the 100-point VAS are 'Not at all' to 'Completely trust'. Participants indicate their level of trust in the MI advice after every trial on a scale from 1-100, with higher scores indicating greater levels of trust.

    The trust change, as measured by the visual analog scale, will be calculated using the following formula:

    Trust change (i) = Trust(i) - Trust(i - 1), where i=2, 3, ..., 100.

    To compute a single, summarized value for the Trust Change variable within a specific scenario, the individual Trust Change scores measured from the trials are averaged. This averaging method provides a comprehensive measure of how trust shifted across the duration of the scenario.

  4. Trust

    Time frame: Post-intervention in Scenarios 1 and 2.

    Trust will be assessed using the Muir & Moray's (1996) Trust in Automation scale. Scores range from 0 to 100 with higher scores indicating greater levels of trust.

Secondary outcomes

  1. Cognitive Effort

    Time frame: Throughout the verification task

    Participants' eye movements were tracked using a browser-based online eye tracking system. The outcome measure is the difference in cognitive effort as measured by fixation count in the defined areas of interest: fill image, reference image, or MI plot. Higher fixation rates indicate repeated interest in a certain area.

  2. Cognitive Effort

    Time frame: Throughout the verification task

    Participants' eye movements were tracked using a browser-based online eye tracking system. The outcome measure is the difference in cognitive effort as measured by the duration of fixations in the defined areas of interest: fill image, reference image, or MI plot. Longer fixation duration indicates a higher cognitive load.

  3. Workload

    Time frame: After completing 100 mock verification trials in each arm

    Participants will complete 100 mock medication verification trials in each of the 3 arms. The workload of each arm will be measured by the NASA Task Load Index (TLX). The 5 TLX dimensions assessed are: mental demand, effort, temporal demand, performance, and frustration. For each dimension, participants will indicate their response to a single question. For 4 of the dimensions, the endpoints of the Likert scale are 'very low' and 'very high'. The performance dimension is reverse-scored, and the endpoints are 'perfect' and 'failure'. Participants then complete 10 pairwise comparisons of the dimensions by indicating which dimension they consider to be a more important factor (e.g., effort vs frustration).

    Each category score multiplied by its respective pairwise comparison count is summed and divided by 10 to get an overall weighted workload score. The result is an overall workload score between 1 and 20, with higher scores indicating higher workload.

  4. Usability

    Time frame: After completing 100 mock verification trials in each arm

    Participants will complete 100 mock medication verification trials in each of the 3 arms (No MI Help, Scenario 1, and Scenario 2). After completing 100 trials, participants will assess the mock verification interface using the System Usability Scale (SUS). The SUS is comprised of 10 statements that participants indicate their agreement with using a 5-point Likert scale ranging from strongly agree to strongly disagree. Odd-numbered questions have a positive response and even-numbered questions are reverse-scored. Scores are summed and multiplied by 2.5 to get a final SUS score. SUS scores range from 0 to 100 with higher scores indicating greater usability. An average SUS score is considered to be 68. Anything below 50 is "Not Acceptable. Scores between 51-70 are considered "Marginal", those above 71 are considered "Acceptable", and those at 80 or above are indicative of high usability.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Library of Medicine (NLM)

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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