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

Judy Munday; Jed Duff; Fiona M Wood; David Sturgess; Samantha Keogh; Nicholas Ralph; Nicole M White; Hannah Carter; Ian D Graham

doi:10.1136/bmjopen-2024-091577

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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

Journal article

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Peer reviewed

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

Judy Munday, Jed Duff, Fiona M Wood, David Sturgess, Samantha Keogh, Nicholas Ralph, Nicole M White, Hannah Carter and Ian D Graham

BMJ Open, Vol.15(2), pp.1-10

2025

DOI: https://doi.org/10.1136/bmjopen-2024-091577

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Abstract

ANAESTHETICS

Clinical Trial

Health services research

Implementation Science

Nursing Care

SURGERY

Introduction: 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. Methods and analysis: 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. Ethics and dissemination: 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. Trial registration number: Prospective registration of the trial was obtained on 28 July 2023 on the Australia and New Zealand Clinical Trials Registry Network: ACTRN12623000814673.

Details

Title: 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
Authors: Judy Munday (Corresponding Author) - University of the Sunshine Coast, Queensland, School of Health - Sports & Exercise Science
Jed Duff - Queensland University of Technology
Fiona M Wood - The University of Western Australia
David Sturgess - The University of Queensland
Samantha Keogh - Queensland University of Technology
Nicholas Ralph - University of the Sunshine Coast, Queensland, School of Health - Nursing
Nicole M White - Queensland University of Technology
Hannah Carter - Queensland University of Technology
Ian D Graham - University of Ottawa
Publication details: BMJ Open, Vol.15(2), pp.1-10
Publisher: BMJ Group
Date published: 2025
DOI: 10.1136/bmjopen-2024-091577
ISSN: 2044-6055
Copyright note: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Grants: The PeriWarm Trial: Transforming perioperative temperature management for better patient outcomes, 2015532, National Health and Medical Research Council (Australia, Canberra) - NHMRC
Organisation Unit: School of Health - Nursing
Language: English
Record Identifier: 991103625202621
Output Type: Journal article

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Web Of Science research areas: Health Care Sciences & Services

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