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

Machine Learning Clinical Trial

— IMAGINATIVE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05809232
• Other study ID #: IMAGINATIVE Trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: December 2027

Study information

• Verified date: March 2023
• Source: Singapore General Hospital
• Contact: Hairil Rizal Abdullah, MBBS
• Phone: 63265428
• Email: hairil.rizal.abdullah[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9200
• Est. completion date: December 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Machine Learning

Intervention

Other:
• CARES-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).

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Shift in adoption rate of CARES's CDS recommendations among anesthesiologists, intensivists, surgeons and nurses	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.	Five years
Primary	Change in perioperative mortality rates	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.	Five years
Secondary	Change in potentially avoidable planned ICU admission after surgery	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	Five years