Avendano‐Cespedes 2016.
Study characteristics | ||
Methods | Design: RCT Date of study: Oct 13 to Feb 14 Power calculation: pilot sample calculated to detect 10% reduction in delirium from 20% in control group with upper 1 sided 80% confidence limit (power not specified) – sample size of 50 selected Inclusion criteria: >=65, Hospitalised on acute geriatric unit of participating hospital (single‐site) between Oct 13 and Feb 14, Valid informed consent (patient or their legal representative) Exclusion criteria: quote: "Agonic situation" (presume palliative care), Non‐Spanish speaking Severe cognitive decline (Reisberg's Global Deterioration Scale = 7), patient sharing a room with a previously included participant (to avoid contamination bias) |
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Participants | Sample size: 50 Country: Spain Setting: acute geriatric unit in one tertiary University hospital Age: Mean age 85.8 (SD = 6.2) in intervention, mean age 87.0 (SD 4.9) in control Overall 86.5 (5.5) Sex: Males, 10 (47.6%) in intervention, males 16 (32%) in control Overall males 26 (52%) Co‐morbidity: mean Charlson comorbidity index score 2.1 (1.7) in intervention group, 2.2 (1.3) in control group. Data reported on physiological parameters including blood pressure, temperature and oxygen saturation– no major imbalances between groups. Dementia: patients with ‘severe’ cognitive impairment were excluded – Reisberg's Global Deterioration scale = 7 (end‐stage dementia). Other stages of dementia are included. Frailty: not reported |
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Interventions | Intervention:the intervention was carried out exclusively by the “intervention nurses”, and was composed of two main parts, being the first one a risk factor analysis, and the second one the a daily multicomponent non‐pharmacologic intervention (orientation, sensorial deficit, sleep, mobilisation, hydration, nutrition, drug chart review, elimination, oxygenation, pain), on the risk factors detected. The intervention nurses identified the principal caregiver in the first 24 hours from admission, and provided an informative booklet about strategies and recommendations to prevent delirium incidence, including ambient strategies, orientation abilities, and identification of alert signs. Participants received the initial intervention in the first 24 hours from admission, and thereafter daily until hospital discharge. Control: Usual medical and nursing care throughout the hospitalisation process. No booklet |
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Outcomes | Outcomes reported: ‐ Incident delirium using CAM ‐ Prevalent delirium, at any point during hospitalisation, using CAM ‐ New diagnosis of dementia using Pfeiffer Short Portable Mental Status Questionnaire and Reisberg Global Deterioration Scale ‐ Duration of delirium episode (days) ‐ Peak severity of delirium using validated instruments ‐ Length of hospital admission (days) ‐ Use of new psychotropic medication during admission ‐ Withdrawal from protocol by participants Outcomes not reported: none Frequency of outcomes assessment: daily assessment for delirium whilst in hospital |
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Notes | Funding source: Funded by RD12/0043RETICEF, Instituto de Salud Carlos III, Ministerio de Economíay Competitividad Declarations of interest: none declared Multiple measures of delirium reported. Those with delirium on first day are highlighted in various analyses presented, but difficult to ascertain denominator and use the data presented in narrative and tables as some inconsistency in reporting. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was computer‐based using computer‐generated random numbers with a proportion of 1:1 between control group and intervention group. |
Allocation concealment (selection bias) | Low risk | After randomisation before participant allocation, opaque envelopes were used to store the data with sequential study numbers |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of investigator and participants was not possible due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessment was conducted blinded to allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | Reporting in accordance with pre‐registered trial protocol |
Other bias | Low risk | No evidence of other bias |