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NCT Number: NCT05809232

Impact of Machine Learning-based Clinician Decision Support Algorithms in Perioperative Care

Predicting surgical risks are important to patients and clinicians for shared decision making process and management plan. The study team aim to conduct a hybrid type 1 effectiveness implementation study design. A Randomized Controlled Trial where participants undergoing surgery In Singapore General Hospital (SGH) will be allocated in 1:1 ratio to CARES-guided (unblinded to risk level) or to unguided (blinded to risk level) groups. All participants undergoing elective surgeries in SGH will be considered eligible for enrolment into the study. For elective surgeries, the participants will mainly be recruited from Pre-admission Centre. The outcome of this study will help patients and clinicians make better decisions together. Firstly, the deployment of the CARES model in a live clinical environment could potentially reduce postoperative complications and improve the quality of surgical care provision. The findings from this study would allow fine-tuning of CARES as well as further deployment of additional risk models for specific complications other than Mortality and ICU stay. This in turn would translate to better health for the surgical population and improved cost-effectiveness. This is significant as the surgical population is expected to continuously grow due to improved access to care, better technologies and the aging population. Secondly, IMAGINATIVE will be instrumental in improving our understanding of the deployment strategies for AI/ML predictive models in healthcare. Models such as CARES could be the standard of care in the future if proven to improve the health outcomes of patients. As model deployments are costly and can be disruptive to the EMR processes, this study would be the initial spark for future deployment and health services research focusing on improving the value of these model deployments.

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Key information

Conditions

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore

Location contact

Brian Goh Kim Poh, MBBS

SUB_INVESTIGATOR

Ecosse Lamoureux, PHD

SUB_INVESTIGATOR

Elaine Lum, PHD

SUB_INVESTIGATOR

Gek Hsiang Lim, MSC

SUB_INVESTIGATOR

Hairil Rizal Abdullah, MMED

CONTACT

[email protected]

Hairil Rizal Abdullah, MMED

PRINCIPAL_INVESTIGATOR

Jacqueline Sim Xiu Ling, MBBS

SUB_INVESTIGATOR

Marcus Ong Eng Hock, MPH

SUB_INVESTIGATOR

Mengling Feng, PHD

SUB_INVESTIGATOR

Nan Liu, PHD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients >=21 Years old
  • Patients going for elective surgery

For semi-structured interview:

  • Any clinician or nurse that used CARES during the research trial

Exclusion criteria

  • Patients with reduced mental capacity
  • Patients who are unable to give consent

Treatment and study plan

CARES-guided Group

Other

Participants randomised to the CARES-guided arm will have their CARES-score calculated and entered into the Pre-Anesthesia Assessment electronic form within the Electronic Medical Records (EMR). This score and its relevant advisories will be prominently displayed on this electronic form. (Participants on this arm will receive this intervention in addition to the routine practice).

Primary outcomes

  1. Change in perioperative mortality rates

    Time frame: Five years

    To assess the effectiveness of the Machine Learning Clinical Decision Support (ML-CDS). Hypothesis: The CARES-guided group will have a 30% relative reduction in one-year mortality rate due to the increased clinician awareness of the risks.

Secondary outcomes

  1. Change in potentially avoidable planned ICU admission after surgery

    Time frame: Five years

    To assess the effectiveness of the ML-CDS algorithm in optimizing ICU bed utilization, which is an important and costly hospital resource Hypothesis: There will be a 25% relative reduction in the potentially avoidable planned ICU admission after surgery in the CARES-guided group

Other outcomes

  1. Shift in adoption rate of CARES's CDS recommendations among anesthesiologists, intensivists, surgeons and nurses

    Time frame: Five years

    To assess adoption and acceptability, and to understand user experience and concerns regarding an ML based prediction application designed to improve patient safety in a clinical setting. Hypothesis: There is high adoption of CARES's CDS recommendations among anesthesiologists, intensivists, surgeons and nurses respectively.

Study contacts

Contact information is provided by the study sponsor or research team.

Hairil Rizal Abdullah, MBBS

CONTACT

[email protected]

63265428

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

Impact of Machine Learning-based Clinician Decision Support Algorithms in Perioperative Care - A Randomized Control Trial (IMAGINATIVE Trial)

Acronym: IMAGINATIVE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

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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