NCT06245044

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 26, 2025

Completed
Last Updated

November 26, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

January 5, 2024

Results QC Date

September 10, 2025

Last Update Submit

November 12, 2025

Conditions

Keywords

pharmacymedication verificationartificial intelligencemachine intelligence

Outcome Measures

Primary Outcomes (4)

  • Reaction Time

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

    Throughout the verification task

  • Decision Accuracy

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

    Throughout the verification task

  • Trust Change

    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.

    After every trial in Scenarios 1 and 2

  • Trust

    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.

    Post-intervention in Scenarios 1 and 2.

Secondary Outcomes (4)

  • Cognitive Effort

    Throughout the verification task

  • Cognitive Effort

    Throughout the verification task

  • Workload

    After completing 100 mock verification trials in each arm

  • Usability

    After completing 100 mock verification trials in each arm

Study Arms (3)

No MI Help

EXPERIMENTAL

No MI help will be presented during the verification tasks

Behavioral: No MI HelpBehavioral: Scenario #1Behavioral: Scenario #2

Scenario #1

EXPERIMENTAL

MI help will be presented in the form of a pop-up message the participant's decision differs from the MI's determination.

Behavioral: No MI HelpBehavioral: Scenario #1Behavioral: Scenario #2

Scenario #2

EXPERIMENTAL

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

Behavioral: No MI HelpBehavioral: Scenario #1Behavioral: Scenario #2

Interventions

No MI HelpBEHAVIORAL

Participants will complete the medication verification task without any MI help

No MI HelpScenario #1Scenario #2
Scenario #1BEHAVIORAL

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

No MI HelpScenario #1Scenario #2
Scenario #2BEHAVIORAL

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

No MI HelpScenario #1Scenario #2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

Title
Dr. Corey Lester
Organization
University of Michigan

Study Officials

  • Corey A Lester, PharmD, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Pharmacy

Study Record Dates

First Submitted

January 5, 2024

First Posted

February 7, 2024

Study Start

April 11, 2024

Primary Completion

December 4, 2024

Study Completion

December 4, 2024

Last Updated

November 26, 2025

Results First Posted

November 26, 2025

Record last verified: 2025-09

Locations