# Implementing Guidelines for hypothermia prevention with Local adaptation to keep periOperative patients Warm (GLOW): protocol of a stepped-wedge cluster randomised hybrid type II effectiveness-implementation study

## TL;DR

This study aims to reduce perioperative hypothermia by adapting hypothermia prevention guidelines to local hospital settings and evaluating their effectiveness and implementation.

## Contribution

The study introduces a hybrid effectiveness-implementation trial design with local adaptation of hypothermia prevention guidelines in a stepped-wedge cluster randomized trial.

## Key findings

- The stepped-wedge design will assess clinical outcomes like hypothermia incidence and implementation outcomes like warming practices.
- Cost-effectiveness and quality-adjusted life years will be evaluated alongside clinical and implementation outcomes.
- Findings will inform practice and policy recommendations through collaborative development with partner organizations.

## Abstract

Perioperative hypothermia is a common and preventable complication of surgery. Systems level change that enables perioperative teams to integrate hypothermia prevention into practice in ways that are contextually appropriate is needed. The purpose of this trial is to evaluate the effectiveness and implementation of perioperative hypothermia prevention guidance with local adaptation on clinical, implementation and economic outcomes. Our objective is to decrease the risk of patients developing perioperative hypothermia.

A hybrid type II effectiveness-implementation study. An incomplete stepped-wedge cluster randomised controlled trial design will be used, with a 6-month transition period for implementation. Perioperative departments from five major public hospitals in South East Queensland, Australia, will participate over 27 months. The co-primary outcomes are (effectiveness) hypothermia on arrival to the post anaesthetic care unit (PACU) and (implementation) extent of temperature monitoring and active warming. Secondary clinical effectiveness outcomes include hypothermia at any perioperative time point, PACU and hospital length of stay, intraoperative or post-anaesthetic adverse events, blood transfusions and surgical site infection. Secondary implementation outcomes include pre-transition measures of adoptability and implementability, and post-transition measures of adoption, fidelity of implementation strategy and site team learning. Cost-effectiveness will evaluate implementation costs and quality-adjusted life years. Based on the number and unequal sizes of clusters, we used a constrained randomisation approach for sample size determination to minimise the imbalance between control and intervention period sample sizes. Generalised linear mixed models will be used to analyse primary and secondary outcomes.

Ethical approval was obtained with a waiver of consent to access clinical records (reference: HREC/2023/MNHB/94571). Informed consent will be sought from patients completing surveys. Consent will be implied from clinicians participating in implementation evaluation. Findings will be disseminated through journal publications and conference presentations. Practice and policy recommendations will be collaboratively developed with partner organisations.

Prospective registration of the trial was obtained on 28 July 2023 on the Australia and New Zealand Clinical Trials Registry Network: ACTRN12623000814673.