Watne 2014.
Study characteristics | ||
Methods | Design: RCT comparing care in an acute geriatric ward or standard orthopaedic ward following hip fracture Date of study: September 2009 ‐ January 2012 Power calculation: yes but powered for primary outcome of cognitive function not delirium Inclusion criteria: all acute admissions to Oslo University Hospital with a hip fracture Exclusion criteria: hip fracture due to high energy trauma (defined as a fall from higher than one metre) or if they were moribund on admission |
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Participants | Number in study: 332 randomised; 329 included in analyses Country: Norway Setting: university hospital Age: mean age 84 years (range: 55 to 99) for intervention group and 85 years (range: 46 to 101) Sex: male 42 (26%) for intervention group; 38 (23%) for controls Co‐morbidity: not reported Dementia: 49% in both intervention and control groups diagnosis by expert evaluation Frailty: not reported |
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Interventions | Intervention: acute geriatric ward – 20 bed ward mainly admitting patients suffering from acute medical disorder superimposed upon frailty, co‐morbidities and polypharmacy. Comprehensive Geriatric Assessment was the basis for treatment planning. Assessment by geriatrician, nurse, physiotherapist and occupational therapists was expected during their first day on the ward and this team had daily meetings to plan discharge. Checklists and clinical routines based on published literature and previous experience. These included medication reviews, optimal pain control, correction of physiological disturbances preoperatively and postoperatively (hypoxaemia, anaemia, electrolyte disturbances, acid–base disturbances, dehydration, hypotension, blood sugar etc), early and intensive mobilisation, optimising pre‐ and postoperative nutrition and early discharge planning. Outpatient orthopaedic clinic at 4 months. Control: usual care in orthopaedic ward setting. Staffing levels were similar but there was no multidisciplinary meetings and no geriatric assessments. Early mobilisation was emphasised and patients were seen by a physiotherapist soon after surgery. Outpatient orthopaedic clinic at 4 months. |
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Outcomes | Outcomes reported:
‐ Incident delirium using CAM ‐ In‐hospital mortality ‐ Incident dementia at 12 months ‐ Delirium duration (days) ‐ Delirium severity using MDAS ‐ Length of stay ‐ ADL function using Barthel Index at four months ‐ New care home residence at four and 12 months ‐ Falls ‐ Pressure ulcers ‐ Postoperative complications Outcomes not reported: None Frequency of outcomes assessment: daily using CAM preoperatively and until the fifth postoperative day or for patients with delirium until discharge |
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Notes | Funding source: Research Council of Norway through the program ‘Improving mental health of older people through multidisciplinary efforts’ (Grant No: 187980/H10) plus Oslo University Hospital, The Sophies Minde Foundation, The Norweigan Association for Public Health and Civitan’s Research Foundation Declaration of interest: the authors declare ‘they have no competing interests’ Delirium not excluded at enrolment There are concerns about the fidelity of the intervention received as, when a bed was not available in the unit, care was provided in a corridor. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers (blocks of variable and unknown size) carried‐ out by statistician not involved in clinical service |
Allocation concealment (selection bias) | Low risk | Allocation by sealed‐opaque numbered envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Delirium assessments were performed by study nurse/geriatrician aware of allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Three moribund patients erroneously randomised were excluded from the analysis (2 from intervention and 1 from control arm) |
Selective reporting (reporting bias) | Low risk | Study reported in accordance with published protocol |
Other bias | Low risk | No evidence of other bias |