RecruitingACTRN12623000814673

The GLOW Trial: implementing Guidelines for hypothermia prevention with Local adaptation to keep periOperative patients Warm.

Implementing Guidelines for hypothermia prevention with Local adaptation to keep periOperative patients Warm (the GLOW Trial): A stepped wedge cluster trial to evaluate the effectiveness of consensus-based perioperative hypothermia prevention recommendations.


Sponsor

University of the Sunshine Coast

Enrollment

12,732 participants

Start Date

Nov 27, 2023

Study Type

Interventional

Conditions

Summary

Over 1.2 million Australian patients are at risk of experiencing perioperative hypothermia (heat loss to below 36°C) annually, with a cost of over $1.2 billion to the Australian health care system. Perioperative hypothermia is associated with numerous adverse outcomes including increased wound infection, increased blood loss, longer hospital stays, patient discomfort and poor surgical experience. Prevention involves consistent temperature monitoring and appropriate use of warming strategies throughout surgery. However, in Australia, temperature monitoring during surgery occurs in around 20% of procedures and rates of perioperative hypothermia remain high at approximately 27% of patients. Our trial will evaluate practice recommendations and an implementation strategy for sustainable improvement in perioperative hypothermia prevention in Australian hospitals.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

It might come as a surprise, but a significant number of patients who have surgery end up with a lower-than-normal body temperature — a condition called perioperative hypothermia. This happens when the body loses heat during the procedure and isn't properly monitored or warmed. The consequences are serious: more wound infections, greater blood loss, longer hospital stays, and patient discomfort. Yet in Australia, temperature is only monitored in about 20% of surgical procedures. The GLOW Trial is evaluating a practical, hospital-wide implementation strategy to improve how Australian hospitals monitor and maintain body temperature during surgery. Rather than testing a new drug or device, this study is focused on changing clinical practice — implementing evidence-based guidelines consistently across multiple hospital sites. You may be eligible as a patient if you are aged 16 or older and are having elective or emergency surgery under general or neuraxial anaesthesia. Clinicians working in perioperative departments are also invited to contribute to implementation surveys. Patients having only local anaesthesia, cardiac surgery, or obstetric surgery are not included in the main dataset.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention - implementation of perioperative hypothermia prevention principles and practice recommendations supported by internal and external facilitation. During a 6-month implementation transit

Intervention - implementation of perioperative hypothermia prevention principles and practice recommendations supported by internal and external facilitation. During a 6-month implementation transition period, local adaptation and implementation of the principles and practice recommendations will commence. Each cluster (perioperative department) will be provided with internal and external facilitation support for implementation of perioperative hypothermia recommendations comprising of 1. Simple principles for perioperative hypothermia prevention; 2. Supporting detailed practice recommendations. The recommendations comprise of the three domains of hypothermia prevention: (1) monitoring temperature, (2) warming actively, (3) minimising exposure. Examples of the practice recommendations include: (1) Monitoring Temperature - Actively monitoring temperature for all patients at all times; (2) Warm Actively - warm actively to keep temperature above 36°C; (3) Minimise Exposure - minimise exposure to cold at all stages of perioperative care. Intervention - Implementation Strategy The core components of the implementation strategy are 1. a team-based approach to implement the recommendations with local adaptation; 2. expert facilitation and structured support. Each cluster (perioperative department) will form a Site Implementation Team including registered nurses, anaesthetists and surgeons. Internal facilitation will be provided within each department by a Registered Nurse. External facilitation is provided by the research team. The Site Implementation Teams will adapt the recommendations, according to context, while working through an implementation process that is guided by the Knowledge-to-Action framework. External facilitators will support internal facilitators and the Site Implementation Teams to work through the implementation process and adapt the recommendations to context, using the Knowledge-to-Action framework. Facilitation will provide both practical and theoretical support. The Site Implementation Teams will be provided with (1) the simple principles and detailed practice recommendations, and (2) implementation materials based on the Knowledge-to-Action framework, including an implementation guide (designed specifically for this study), electronic repository of implementation information and tools. The implementation teams will facilitate the adoption of recommendations and choose implementation strategies based on local context and needs. Examples may include local audit and feedback, priority setting and workshops, small scale testing of practice change using Plan Do Study Act (PDSA) cycles. Intervention duration: each cluster will be randomized to commence the implementation transition phase which is 6 months in duration. Site Implementation Teams meet at an initial one-day workshop at the commencement of the six-month phase, then weekly throughout the six months. Sites then switch to the Intervention period of data collection and remain in the Intervention period until the end of the trial, between 8 to 18 months. Intervention fidelity - activity logs will be used to assess fidelity to the implementation strategy.


Locations(5)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

Sunshine Coast University Hospital - Birtinya

QLD, Australia

Mater Hospital Brisbane - South Brisbane

QLD, Australia

Ipswich Hospital - Ipswich

QLD, Australia

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ACTRN12623000814673