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)

Abstract

Number of tables: 3 Number of figures: 3 Number of references: 38 Word count: 2936 Background Delirium is a common debilitating complication of advanced cancer. ObjectiveTo determine if a multicomponent non-pharmacological delirium prevention intervention was feasible for adult patients with advanced cancer, prior to a phase III (efficacy) trial. DesignPhase II (feasibility) cluster randomized controlled trial. All sites implemented delirium screening and diagnostic assessment. Strategies within sleep, vision and hearing, hydration, orientation, mobility and family domains were delivered to enrolled patients at intervention sites admission days 1-7.Control sites then implemented the intervention ('waitlist sites'). SettingFour Australian palliative care units MeasurementsThe primary outcome was adherence, with an a priori endpoint of at least 60% patients achieving full adherence. Secondary outcomes were interdisciplinary care delivery, delirium measures and adverse events, analyzed descriptively and inferentially. ResultsSixty-five enrolled patients (25 control, 20 intervention, 20 waitlist) had 98% delirium screens and 75% diagnostic assessments completed. Nurses (67%), physicians (16%), allied health (8.4%), family (7%), patients (1%) and volunteers (0.5%) delivered the intervention. There was full adherence for 5% patients at intervention sites, partial for 25%. Both full and partial adherence was higher at waitlist sites: 25% and 45%, respectively. One-third of control site patients (32%) became delirious within seven days of admission compared to one-fifth (20%) at both intervention and waitlist sites (p=0.5). Mean (SD) Delirium Rating Scale-Revised-1998 scores were 16.8 +12.0 control sites versus 18.4 +8.2 (p=0.6) intervention and 18.7 +7.8 (p=0.5) waitlist sites. The intervention caused no adverse events. ConclusionThe intervention requires modification for optimal adherence in a phase III trial.

The experience of delirium in palliative care settings for patients, family, clinicians and volunteers: A qualitative systematic review and thematic synthesis

“…In view of the lack of evidence to support the routine use of medication for delirium symptoms, an increased focus is needed on non-pharmacological approaches to care, including prevention. 10 …”

“…In view of the lack of evidence to support the routine use of medication for delirium symptoms, an increased focus is needed on non-pharmacological approaches to care, including prevention. 10 The WHO definition identifies family as important recipients of palliative care, as well as the patient. 34 The included studies demonstrated that clinicians went beyond 'person-centred' care of the patient, in responding to the distress and needs of the family.…”

“…6,7 Despite its profound impact, there has been little research into non-pharmacological prevention and management of delirium in palliative care settings, and only a limited number of trials investigating its management with medication. 8,9,[10][11][12][13] Evidence and guidelines from other settings are useful, but the development of palliative care specific interventions to improve delirium care is needed. To inform clinical practice and the development of such interventions, a greater understanding of delirium experiences, care practices and the specific influences that shape them from the perspectives of all relevant stakeholders in the palliative care context is needed.…”

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

“…The authors declare that there is no conflict of interest. 22,23,25 Open label RCT 24,26 Clustered RCT 27 26 Single blind RCT 29 Historical control study 30 Before and after study 31 Non-randomised study Palliative care unit or inpatient hospice 25,27,28,30,31 Hospital palliative care 24,[32][33][34] Palliative care unit/hospice and hospital 23,26,29 Community palliative care 22…”

“…Direct care [22][23][24][25][26][27][28][29][30][31]34 11 Not reported 32,33 Disciplines involved in service Medical and nursing…”