Bonaventura 2007.
Study characteristics | ||
Methods | Design: RCT of a multi‐component intervention, the Intervention to Prevent Delirium (IPD) in older patients admitted to medical and geriatric wards Date of study: 2005 to 2006 Power calculation: no Inclusion criteria: age > or = to 65 years admitted to medical and geriatric wards in one hospital Exclusion criteria: MMSE score < or =25, at least 1 relative not present, transfer out of ward, pre‐existing dementia, blindness, deafness, aphasia or unable to understand Italian |
|
Participants | Number in study: 60 Country: Italy Setting: medical and geriatric wards Age: not given Sex M:F: Intervention 12/18, Control 12/18 Co‐morbidity: comparable P = 0.77 Dementia: excluded Frailty: not reported |
|
Interventions | Intervention: Intervention to Prevent Delirium (IPD), a series of structured and standardised welfare actions based on existing guidelines, including support in the following areas: cognitive re‐orientation, sensory and environmental, mobilisation, hydration, and 'socio‐emotional' Control: usual care, not described further |
|
Outcomes | Outcomes reported: ‐ Incident delirium measured using CAM & DRS‐R‐98 ‐ Functional performance using Barthel Index Outcomes not reported: none Frequency of outcomes assessment: days 1, 2, 4 and 7 of admission |
|
Notes | Funding source: not reported Declarations of interest: not reported Delirium not excluded at enrolment |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Sequence generated using day of admission |
Allocation concealment (selection bias) | High risk | Odd and even days of admission used so concealment unlikely |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel not blinded, not possible given nature of the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessment blinding not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Insufficient information presented to make judgment |
Other bias | Low risk | No evidence of other bias |