Moon 2015.
Methods | Single‐blind, randomized controlled trial Setting: ICU (105 beds) in a general hospital with 1049 beds Country: Republic of Korea Groups: preventive delirium protocol according to a nursing algorithm that addressed cognition and orientation, environmental factors and early therapeutic intervention vs. usual care Period: March 2013 to May 2013 |
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Participants |
Sample size: 134 (60/63) Included
Excluded
Missing: (5/6); all are accounted for in flowchart. |
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Interventions |
Intervention: the first 7 days in the ICU a delirium‐prevention nursing algorithm covering cognitive assessment and orientation, environment intervention (assessment of hearing impairments, sleep management, aroma therapy, comfort) and early therapeutic intervention (nutrition, fluid and electrolyte balance, early mobilization, sleeping pills, early detection of infection, removal of unnecessary catheters, avoidance of hypoxia and pain control) was used. Control: no provision of preventive delirium nursing (i.e. typical nursing care included regular checking of consciousness and orientation without attempting to:
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Outcomes |
Primary
Secondary
Delirium was measured by: CAM‐ICU Adverse events: none reported |
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Notes |
Conclusion: the protocol had no significant effect on delirium incidence, in‐hospital mortality, re‐admission to the ICU, or length of ICU stay. The intervention is described in very general terms and includes 'state of the art' good ICU nursing care, making replication of the study and, if relevant, implementation of the intervention into clinical practice difficult. The control group received standard care entailing no provision of proactive "delirium prevention nursing". No power calculation was conducted prior to the study, the sample is seemingly a result of 3 months of data collection Funding: research fund from College of Nursing, The Catholic University of Korea Conflict of interest: not declared Study number: not stated Contact with author: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Opaque assignment cards indicating assignment to the intervention group (70 cards) or control group (70 cards) were placed in a large envelope and shuffled before the envelope was sealed |
Allocation concealment (selection bias) | Unclear risk | Leader of nursing team drew a card and did not replace it afterwards: theoretically, the allocation of the last cases can be guessed by the previous allocations before the large envelope was empty |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Flowchart accounts for all patients throughout the study |
Selective reporting (reporting bias) | Unclear risk | All predefined outcomes listed in the paper were reported. It was not possible to check with an online protocol |
Other bias | Unclear risk | No discussion related to possible spill‐over from intervention to control patients |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Allegedly patients were unaware of intervention; however we suspect patients could be aware as masking the intervention seems impossible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were not blinded |