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.
University of the Sunshine Coast
12,732 participants
Nov 27, 2023
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
Inclusion Criteria2
- Patient participants: Adults aged 16yrs or older having undergone general or neuraxial, elective or emergency surgery at the hospital site during the site's control or intervention period will be eligible for inclusion. A random sample of patients undergoing elective surgery will be approached prior to surgery to participate in the collection of data for patient-reported outcomes (Quality of Life, self-reported wound healing) in addition to clinical outcomes collected for the main study.
- Clinicians: For the implementation outcomes, clinicians will be included in implementation evaluation surveys if they have been involved in the Site Implementation Team (including registered or enrolled nurses, anaesthetic technicians, surgical and anaesthetic medical personnel). In addition, any clinician working in the perioperative department including registered or enrolled nurses, anaesthetic technicians, surgical and anaesthetic medical personnel) during the study period will be eligible to complete the surveys assessing Organisational Readiness for Implementation in addition to evaluation of the recommendations (feasibility, acceptability).
Exclusion Criteria2
- Patient participants
- Patients receiving planned therapeutic hypothermia or undergoing local anaesthesia only, or local anaesthesia with sedation only, or sedation only will be excluded. Patients who are transferred directly to the Intensive Care Unit from operating theatres and bypass the Post Anaesthetic Care Unit will be excluded from data collection. Patients who are who are undergoing cardiac or obstetric surgery, will be excluded from data collection.
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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 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)
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ACTRN12623000814673