Martinez 2012.
Study characteristics | ||
Methods | Design: RCT of a multi‐component delirium prevention intervention provided by family members Date of study: September 2009‐June 2010 Power calculation: yes Inclusion criteria: all patients at risk for delirium (> 70 years, cognitive impairment (MMSE < 24 prior to admission) alcoholism or metabolic imbalance at admission) Exclusion criteria: delirium at admission, no family support, admitted to ward other than general medicine, those in a room with more than two beds |
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Participants | Number in study: 287 Country: Chile Setting: internal medicine ward of acute hospital Age: mean age 78.1 years (SD 6.3) in intervention group; 78.3 years (6.1) in control group Sex: 42% female in intervention group; 33% female in control group Co‐morbidity: median Charlson comorbidity index (CCI) 2 (interquartile range, IQR, 1‐4) in intervention group, median CCI 2 (IQR 1‐3) in control group Dementia: 9% in intervention group, 8% in control group Frailty: not reported |
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Interventions | Intervention: multi‐component non‐pharmacological intervention provided by family members, including education regarding confusional syndromes; provision of a clock and calendar; avoidance of sensory deprivation (glasses, denture and hearing aids available as needed); presence of familiar objects in the room; re‐orientation of patient provided by family members; extended visiting times (5 hours daily). Control: usual care from the attending physician |
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Outcomes | Outcomes reported: ‐ Incident delirium, measured using CAM performed daily, throughout admission ‐ Duration of delirium ‐ Length of admission ‐ Falls Outcomes not reported: none Frequency of outcomes assessment: Daily during hospital stay |
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Notes | Funding source: not reported Declarations of interest: quote: "No conflicts of interest declared" Delirium excluded at enrolment |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Randomisation performed by a statistician who was not involved in data collection |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel unblinded due to the nature of the intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors unblinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis performed, 5% loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to assess |
Other bias | Low risk | No evidence of other bias |