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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05809232
Acronym
IMAGINATIVE
Enrollment
9200
Registered
2023-04-12
Start date
2023-05-31
Completion date
2027-12-31
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Machine Learning

Brief summary

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.

Interventions

OTHERCARES-guided Group

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).

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Patients \>=21 Years old 2. Patients going for elective surgery For semi-structured interview: 1\. Any clinician or nurse that used CARES during the research trial

Exclusion criteria

1. Patients with reduced mental capacity 2. Patients who are unable to give consent

Design outcomes

Primary

MeasureTime frameDescription
Change in perioperative mortality ratesFive yearsTo 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

MeasureTime frameDescription
Change in potentially avoidable planned ICU admission after surgeryFive yearsTo 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

MeasureTime frameDescription
Shift in adoption rate of CARES's CDS recommendations among anesthesiologists, intensivists, surgeons and nursesFive yearsTo 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.

Countries

Singapore

Contacts

Primary ContactHairil Rizal Abdullah, MBBS
hairil.rizal.abdullah@singhealth.com.sg63265428

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026