Impact and Safety of AI in Decision Making in the ICU: a Simulation Experiment

Sponsor
Imperial College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05495438
Collaborator
University of York (Other)
40
1
3.3
12.1

Study Details

Study Description

Brief Summary

The impact of deploying artificial intelligence (AI) in healthcare settings in unclear, in particular with regards to how it will influence human decision makers. Previous research demonstrated that AI alerts were frequently ignored (Kamal et al., 2020 ) or could lead to unexpected behaviour with worsening of patient outcomes (Wilson et al., 2021 ). On the other hand, excessive confidence and trust placed in the AI could have several adverse consequences including ability to detect harmful AI decisions, leading to patient harm as well as human deskilling. Some of these aspects relate to automation bias.

In this simulation study, the investigators intend to measure whether medical decisions in areas of high clinical uncertainty are modified by the use of an AI-based clinical decision support tool. How the dose of intravenous fluids (IVF) and vasopressors administered by doctors in adult patients with sepsis (severe infection with organ failure) in the ICU), changes as a result of disclosing the doses suggested by a hypothetical AI will be measured. The area of sepsis resuscitation is poorly codified, with high uncertainty leading to high variability in practice. This study will not specifically mention the AI Clinician (Komorowski et al., 2018). Instead, the investigators will describe a hypothetical AI for which there is some evidence of effectiveness on retrospective data in another clinical setting (e.g. a model that was retrospectively validated using data from a different country than the source data used for model training) but no prospective evidence of effectiveness or safety. As such, it is possible for this hypothetical AI to provide unsafe suggestions. The investigators will intentionally introduce unsafe AI suggestions (in random order), to measure the sensitivity of our participants at detecting these.

Condition or Disease Intervention/Treatment Phase
  • Other: Hypothetical AI

Detailed Description

The impact of deploying artificial intelligence (AI) in healthcare settings in unclear, in particular with regards to how it will influence human decision makers. Previous research demonstrated that AI alerts were frequently ignored (Kamal et al., 2020 ) or could lead to unexpected behaviour with worsening of patient outcomes (Wilson et al., 2021 ). On the other hand, excessive confidence and trust placed in the AI could have several adverse consequences including ability to detect harmful AI decisions, leading to patient harm as well as human deskilling. Some of these aspects relate to automation bias.

In this simulation study, the investigators intend to measure whether medical decisions in areas of high clinical uncertainty are modified by the use of an AI-based clinical decision support tool. How the dose of intravenous fluids (IVF) and vasopressors administered by doctors in adult patients with sepsis (severe infection with organ failure) in the ICU), changes as a result of disclosing the doses suggested by a hypothetical AI will be measured. The area of sepsis resuscitation is poorly codified, with high uncertainty leading to high variability in practice. This study will not specifically mention the AI Clinician (Komorowski et al., 2018). Instead, the investigators will describe a hypothetical AI for which there is some evidence of effectiveness on retrospective data in another clinical setting (e.g. a model that was retrospectively validated using data from a different country than the source data used for model training) but no prospective evidence of effectiveness or safety. As such, it is possible for this hypothetical AI to provide unsafe suggestions. The investigators will intentionally introduce unsafe AI suggestions (in random order), to measure the sensitivity of our participants at detecting these.

The investigators will examine what participant characteristics are linked with an increase likelihood of being influenced by the AI, and conduct a number of pre-specified subgroup analyses, e.g. junior versus senior ICU doctors, and separating those with a positive or a negative attitude towards AI.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Impact and Safety of AI in Decision Making in the ICU: a Simulation Experiment
Actual Study Start Date :
Jul 22, 2022
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
ICU Clinicians

Other: Hypothetical AI
n/a - There is no intervention. Clinicians will review the suggestions of a hypothetical AI

Outcome Measures

Primary Outcome Measures

  1. Influence of AI on ICU Clinicians [3 months]

    Influence of AI on ICU Clinicians, this will be divided into the following categories: overall and stratified by safe/unsafe, junior/senior and positive/negative attitude towards AI.

Secondary Outcome Measures

  1. Participants' characteristics [3 months]

    What are the characteristics of those taking part in the simulation and how does this affect decision making.

  2. Trust in AI [3 months]

    How much do ICU clinicians trust the AI system.

  3. Confidence in participants' decisions [3 months]

    How much confidence do clinicians place in the AI system

  4. Proportion of time with attention on AI explanation [3 months]

    Where is attention focused during the simulation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Junior (senior house officer) or senior (registrar/fellow/consultant) ICU doctor
Exclusion Criteria:
  • Participants not meeting the inclusion criteria.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College Hospitals NHS Trust London United Kingdom W2 1PG

Sponsors and Collaborators

  • Imperial College London
  • University of York

Investigators

  • Principal Investigator: Matthieu Komorowski, MD, PhD, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT05495438
Other Study ID Numbers:
  • 22CX7592
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imperial College London

Study Results

No Results Posted as of Aug 10, 2022