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. 2021 Nov 26;2021(11):CD013307. doi: 10.1002/14651858.CD013307.pub3

Hosie 2020.

Study characteristics
Methods Design: cluster‐RCT
Date of study: 2017
Power calculation:dDetails of formal calculation for future phase III cluster study are detailed in the published protocol;
Inclusion criteria: patients eligible for enrolment were adults (i.e. 18 years of age or older) with advanced (stage 4) cancer.
Exclusion criteria: none specified.
Participants Sample size: 65
Country: Australia
Setting: four specialist palliative care inpatient units within hospitals in metropolitan Australia.
Age: mean age of 76.0 (SD 11.2) in intervention group, 70.5 (15.5) in control group and 68.1 (12.5) in waitlisted group
Sex: 41% of intervention group were male, compared to 65% of the control group and 66% in waitlisted group.
Co‐morbidity: no specific measure of co‐morbidity or health conditions listed by group. Provided breakdown of Australian‐modified Karnofsky Performance Scale which suggests there are differences between the group, however, numbers are very small
Dementia: not reported
Frailty: not reported
Interventions Intervention: the intervention had six domains (eating and drinking, sleep, exercise, reorientation, vision and hearing, and family partnership), containing 36 strategies overall (4–12 per domain). Team members were asked to enlist family and volunteers and tailor the intervention to patients’ needs and wishes. A two‐month site engagement and training period, guided by customised information manuals , preceded control and intervention conditions. Sites formed working groups of interested team members to plan implementation in line with their resources and systems. University‐based researchers attended working group meetings to ensure intervention fidelity, trial integrity, and timely progress. Sites shared meeting records whenever researchers could not attend in person. Training was provided through four discrete 30– to 40‐minute sessions using Biggs’ educational model, delivered multiple times for broadest reach.
Control: control sites received information about delirium prevention strategies when they transitioned to the intervention phase, along with a summary of learnings from intervention sites about optimising trial processes. A key message was that the checklist was not the intervention per se, but essential to measuring the primary outcome of adherence.
Outcomes Outcomes reported:
‐ Incident delirium using Nurses Delirium Screening Scale (Nu‐DESC) and DSM‐V with DRS‐R‐98. 
‐ Inpatient mortality
‐ Severity of delirium (mean, using DRS‐R‐98)
‐ Falls
Outcomes from study not reported: none
Frequency of outcomes assessment: each eight‐hour shift 
Notes Funding source: the trial was funded by an Australian National Breast Cancer Foundation (NBCF) 2017 Pilot Study Grant (Grant code PS‐17‐030).
Declarations of interest: Drs. A.H., J.P., L.L., S.K., S.L.C., A.G., and M.A. and Ms. L.B., B.F., L.E., J.H., R.A., T.A., M.G. and J.W. report a grant from the National Breast Cancer Foundation during the conduct of the study. Dr. A.H. also reports personal fees from Medtronic, outside the submitted work. Dr. G.A.C. reports grants from Bionomics Pty Ltd., outside the submitted work. Dr. E.W.E. reports personal fees from Masimo, grants from VA/NIH, personal fees from Pfizer/Orion, and grants from Koheler, outside the submitted work. All remaining authors have no disclosures to report.
Delirium not excluded at enrolment
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Permuted block randomisation method used
Allocation concealment (selection bias) Low risk Allocation performed by trial statistician at University using above randomisation method.
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of participants and personnel not possible due to study design and nature of intervention
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcome assessment also unblinded
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants accounted for – high proportion in waitlisted site (7/27) did not receive intervention or have data collected but reasons provided, and majority relate to nature of the unit of care (palliative/end of life), rather than the intervention
Selective reporting (reporting bias) Low risk Outcomes reported in accordance with published protocol (BMJ Open citation)
Other bias High risk No evidence of recruitment bias or baseline imbalance associated with cluster design. No loss of clusters. No account made for cluster design in the analytical methods reported.