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. 2018 Nov 23;2018(11):CD009783. doi: 10.1002/14651858.CD009783.pub2

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
Participants Sample size: 134 (60/63)
Included
  1. Age ≥18 years

  2. Ability to understand the study purpose and provide consent for participation independently or via a caregiver serving as a proxy

  3. Hospitalizations for ≥ 48 hours in the ICU


Excluded
  1. A persistent score of ‐4 or ‐5 on the Richmond Agitation and Sedation Scale (RASS)

  2. Severe visual and auditory problems that made CAM‐ICU measurement impossible

  3. Serious psychiatric or neurological diagnosis

  4. Score of 23 on the Mini‐Mental State Examination‐Korean version

  5. Admission to the isolation ward because of infection, death or discharge on the day of admission

  6. Inability to conduct CAM‐ICU measurement when a patient was in a very violent status with RASS +3 or +4.


Missing: (5/6); all are accounted for in flowchart.
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:
  1. provide any information to reorient the patient;

  2. communicate using non‐verbal communication skills, especially by using a device such as a large sheet of paper;

  3. provide personal visual or hearing aids, even when necessary;

  4. assign the same nurse in charge throughout hospitalization;

  5. minimize bed movement; or

  6. carefully use particular medications (e.g. anticholinergic agents and opiates).

Outcomes Primary
  1. Incidence of delirium

  2. In‐hospital mortality


Secondary
  1. Incidence of ICU re‐admission

  2. LOS

  3. ICU stay


Delirium was measured by: CAM‐ICU
Adverse events: none reported
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
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