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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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).

Первичные конечные точки

• Change in perioperative mortality rates [Срок оценки: Five years]

Вторичные конечные точки (1)

• Change in potentially avoidable planned ICU admission after surgery [Срок оценки: Five years]

Критерии участия

Критерии включения

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

For semi-structured interview:

1\. Any clinician or nurse that used CARES during the research trial

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Сингапур · 1 центр

• Singapore General Hospital — Singapore

Публикации

• Abdullah HR, Brenda TPY, Loh C, Ong M, Lamoureux E, Lim GH, Lum E. Protocol for the impact of machine learning-based clinician decision support algorithims in perioperative care (IMAGINATIVE) in Singapore general hospital : a large prospective randomised controlled trial. BMJ Open. 2024 Dec 20;14(12):e086769. doi: 10.1136/bmjopen-2024-086769. PMID 39806608

Идентификаторы

NCT: NCT05809232 · IMAGINATIVE Trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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