Multicomponent non-pharmacological intervention to prevent delirium for hospitalised people with advanced cancer: study protocol for a phase II cluster randomised controlled trial

Abstract

IntroductionDelirium is a significant medical complication for hospitalised patients. Up to one-third of delirium episodes are preventable in older inpatients through non-pharmacological strategies that support essential human needs, such as physical and cognitive activity, sleep, hydration, vision and hearing. We hypothesised that a multicomponent intervention similarly may decrease delirium incidence, and/or its duration and severity, in inpatients with advanced cancer. Prior to a phase III trial, we aimed to determine if a multicomponent non-pharmacological delirium prevention intervention is feasible and acceptable for this specific inpatient group.Methods and analysisThe study is a phase II cluster randomised wait-listed controlled trial involving inpatients with advanced cancer at four Australian palliative care inpatient units. Intervention sites will introduce delirium screening, diagnostic assessment and a multicomponent delirium prevention intervention with six domains of care: preserving natural sleep; maintaining optimal vision and hearing; optimising hydration; promoting communication, orientation and cognition; optimising mobility; and promoting family partnership. Interdisciplinary teams will tailor intervention delivery to each site and to patient need. Control sites will first introduce only delirium screening and diagnosis, later implementing the intervention, modified according to initial results. The primary outcome is adherence to the intervention during the first seven days of admission, measured for 40 consecutively admitted eligible patients. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures. Delirium incidence and severity will be measured to inform power calculations for a future phase III trial.Ethics and disseminationEthical approval was obtained for all four sites. Trial results, qualitative substudy findings and implementation of the intervention will be submitted for publication in peer-reviewed journals, and reported at conferences, to study sites and key peak bodies.Trial registration numberACTRN12617001070325; Pre-results.

Predisposing and precipitating risk factors for delirium in palliative care patients

“…In the current palliative care literature, there is limited evidence about socio-demographic or disease-related predictive factors for delirium in palliative care patients (Bush et al, 2018). In addition, studies, including palliative care patients, have traditionally focused predominantly on delirium prevalence, delirium management, and outcomes rather than investigating risk factors predicting delirium in this vulnerable population (Maltoni et al, 2012; de la Cruz et al, 2015; Boettger and Jenewein, 2017; Hui et al, 2017; Hosie et al, 2019; Lawlor et al, 2019).…”

“…In the current palliative care literature, there is limited evidence about socio-demographic or disease-related predictive factors for delirium in palliative care patients (Bush et al, 2018). In addition, studies, including palliative care patients, have traditionally focused predominantly on delirium prevalence, delirium management, and outcomes rather than investigating risk factors predicting delirium in this vulnerable population (Maltoni et al, 2012;de la Cruz et al, 2015;Boettger and Jenewein, 2017;Hui et al, 2017;Hosie et al, 2019;Lawlor et al, 2019). Considering these findings, in a second analytical step, we sought to identify differences between delirious and non-delirious palliative care patients including a number of delirium risk factors that have been identified in medically ill patients (Schubert et al, 2018;Zipser et al, 2019).…”

Outcomes and measures of delirium interventional studies in palliative care to inform a core outcome set: A systematic review

“…Delirium incidence was determined using a screening tool (Delirium Observation Screening Scale, Confusion Rating Scale, or Nursing Delirium Screening Scale [one study each]) at least daily, followed by a diagnostic assessment using DSM-IV (Diagnostic and Statistical Manual of Mental Disorders -version IV) criteria or the CAM (Confusion Assessment Method) diagnostic algorithm. 28,31,34,36 Measurement for delirium-specific outcome domains generally commenced on admission or at baseline, with highly variable timing of measurement (first measurement timing ranged from 2 hours after intervention to day 4). Two studies did not report measurement frequency.…”

A Multicomponent Nonpharmacological Intervention to Prevent Delirium for Hospitalized People with Advanced Cancer: A Phase II Cluster Randomized Waitlist Controlled Trial (The PRESERVE Pilot Study)

“…Team members documented delivered strategies on a checklist designed for data collection, plus their designation and reason for non-delivery: 'not required', 'patient choice', 'not clinically appropriate', 'not possible with current resources', and 'other'. 19 A two-month site engagement and training period, guided by customized information manuals (available on request), preceded control and intervention conditions. Sites formed working groups of interested team members to plan implementation in line with their resources and systems.…”

“…17 The trial was registered with the Australian and New Zealand Clinical Trials Registry 18 and a protocol detailing its justification and methods was published in January 2019. 19…”