Protocol paper for SMART OPS: Shared decision-making Multidisciplinary Approach - a Randomised controlled Trial in the Older adult Population considering Surgery

Pragya Ajitsaria; Natalie Lott; Angela Baker; Jeanette Lacey; Monique Magnusson; Jeanene Lizbeth Douglas; Paul Healey; Eileen Tan-Gore; Stuart V Szwec; Daniel Barker; Simon Deeming; Meredith Tavener; Steve Smith; Jon Gani; John Attia

doi:10.1136/bmjopen-2022-070159

Protocol paper for SMART OPS: Shared decision-making Multidisciplinary Approach - a Randomised controlled Trial in the Older adult Population considering Surgery

BMJ Open. 2023 Jul 5;13(7):e070159. doi: 10.1136/bmjopen-2022-070159.

Authors

Pragya Ajitsaria^{1

2

3}, Natalie Lott^{2

3

4}, Angela Baker^{5

2}, Jeanette Lacey^{2

6}, Monique Magnusson⁵, Jeanene Lizbeth Douglas⁵, Paul Healey^{5

2}, Eileen Tan-Gore⁴, Stuart V Szwec³, Daniel Barker³, Simon Deeming⁷, Meredith Tavener², Steve Smith^{2

3

6}, Jon Gani^{2

3}, John Attia^{2

3}

Affiliations

¹ Department of Anaesthesia, John Hunter Hospital, Newcastle, New South Wales, Australia pragya.ajitsaria@health.nsw.gov.au.
² School of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia.
³ Hunter Medical Research Institute, Newcastle, New South Wales, Australia.
⁴ Department of Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia.
⁵ Department of Anaesthesia, John Hunter Hospital, Newcastle, New South Wales, Australia.
⁶ Hunter New England Local Health District, New Lambton, New South Wales, Australia.
⁷ Health Research Economics, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.

Abstract

Introduction: The Australian population presenting with surgical pathology is becoming older, frailer and more comorbid. Shared decision-making is rapidly becoming the gold standard of care for patients considering high-risk surgery to ensure that appropriate, value-based healthcare decisions are made. Positive benefits around patient perception of decision-making in the immediacy of the decision are described in the literature. However, short-term and long-term holistic patient-centred outcomes and cost implications for the health service require further examination to better understand the full impact of shared decision-making in this population.

Methods: We propose a novel multidisciplinary shared decision-making model of care in the perioperative period for patients considering high-risk surgery in the fields of general, vascular and head and neck surgery. We assess it in a two arm prospective randomised controlled trial. Patients are randomised to either 'standard' perioperative care, or to a multidisciplinary (surgeon, anaesthetist and end-of-life care nurse practitioner or social worker) shared decision-making consultation. The primary outcome is decisional conflict prior to any surgical procedure occurring. Secondary outcomes include the patient's treatment choice, how decisional conflict changes longitudinally over the subsequent year, patient-centred outcomes including life impact and quality of life metrics, as well as morbidity and mortality. Additionally, we will report on healthcare resource use including subsequent admissions or representations to a healthcare facility up to 1 year.

Ethics and dissemination: This study has been approved by the Hunter New England Human Research Ethics Committee (2019/ETH13349). Study findings will be presented at local and national conferences and within scientific research journals.

Trial registration number: ACTRN12619001543178.

Keywords: ANAESTHETICS; Adult anaesthesia; Adult surgery; GERIATRIC MEDICINE; HEALTH ECONOMICS.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Australia
Decision Making, Shared
Humans
Prospective Studies
Quality of Life*
Randomized Controlled Trials as Topic
Surgeons*

Associated data

ANZCTR/ACTRN12619001543178