Martinez 2012.
| Methods | Design: Randomised controlled trial of a multi‐component delirium prevention intervention provided by family members Date of study: September 2009‐June 2010 Power calculation: Yes Frequency of outcomes assessment: Daily during hospital stay 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 |
|
| 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 |
|
| 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 |
|
| Outcomes | 1. Incident delirium, measured using CAM performed daily, throughout admission 2. Duration of delirium 3. Length of admission 4. Falls |
|
| Notes | Funding source: Not reported Declarations of interest: "No conflicts of interest declared" Delirium excluded at enrolment |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | Randomisation performed by a statistician who was not involved in data collection |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
| 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‐1 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 forms of bias |