Delirium frequently occurs in hospitalized older people, and treatment options are limited. Acupuncture has been shown to reduce agitation in the setting of dementia. The investigators will test the hypothesis that it may also assist in treating delirium.
This randomized-controlled trial aims to evaluate the efficacy of acupuncture integrated with standard care as compared to standard care only for the treatment of delirium in hospitalized older persons. Patients aged 65 and older, hospitalized in the internal medicine departments of Bnai Zion Medical Center and diagnosed with delirium or subsyndromal delirium will be randomized to either true acupuncture with usual care, or usual care only. Daily treatments and outcomes' follow-up will be conducted up to one week from recruitment or until resolution of delirium or subsyndromal delirium for 48 hours. The primary outcome will be delirium resolution evaluated as time-to-first delirium remission (over 7 days) and the number of days spent delirium-free.Side effects will be monitored daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
Acupuncture added to usual care
Bnai Zion Medical Center
Haifa, Golomb 47, Israel
Number of Delirium-free Days During the 7 Days of Evaluation
Number of delirium-free days, based on daily assessment of Confusion Assessment Method scale - a validated diagnostic tool addressing the four features of delirium (acute and fluctuating course, inattention, disorganized thinking and impaired level of consciousness). Definite delirium is defined as the first two features plus either one of the third or fourth, while subsyndromal delirium includes patients not meeting these diagnosis criteria but displaying two or more of these four features including the first one (acute and fluctuating course).
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Time-to-first Remission of Delirium in the 7 Days of Evaluation
Daily assessment of Confusion Assessment Method scale - a validated diagnostic tool addressing the four features of delirium (acute and fluctuating course, inattention, disorganized thinking and impaired level of consciousness). Definite delirium is defined as the first two features plus either one of the third or fourth, while subsyndromal delirium includes patients not meeting these diagnosis criteria but displaying two or more of these four features including the first one (acute and fluctuating course).
Time frame: At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7 of the study
Length of Hospital Stay
Days of hospitalization
Time frame: Through study completion, an average of 2-3 weeks
Functional Status at Discharge
Total Katz Activity of Daily Living (ADL) score at discharge - score assessing activities of daily living, minimum: 0 (worse prognosis), maximum: 6 (best prognosis), calculated as the sum of the following activities (1: independence, 0: dependence): bathing, dressing, toileting, transferring, continence, feeding.
Time frame: Through study completion, an average of 2-3 weeks
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Delirium Severity
Comparison of the sum of long Confusion Assessment Method (CAM-S) score from day 2 (before treatment in the second day of the study) until day 7 (last day of evaluation). CAM-S scale includes 10 delirium-related items, the first one being rated on a 0-1 scale and the nine followings in a 0-2 scale for a total 0-19 score. Higher scores indicate worse outcomes. When summed across 7 days, the total scale range is 0-133 with 0-3 being no delirium, 4-6 being low severity, 7-13 being moderate severity and +/=14 being high severity (Vasunilashorn SM, Marcantonio ER, Gou Y, et al. Quantifying the Severity of a Delirium Episode Throughout Hospitalization: the Combined Importance of Intensity and Duration. J Gen Intern Med. 2016;31(10):1164-1171).
Time frame: Sum of CAM-S at day 2 + day 3 + day 4 + day 5 + day 6 + day 7 of the study
Number of Days in Which Antipsychotic Drugs Were Used
Daily patient chart review for antipsychotic drugs
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Visual Assessment Scale (VAS) for Pain
Daily Visual Assesment Scale - This scale measures pain in a 0-10 score. Higher scores indicate worse pain.
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Sleep
Confusion Assessment Method Severity (CAM-S) scale, tenth item: "sleep-wake cycle". The CAM-S includes 10 delirium-related items, the first one being rated on a 0-1 scale and the nine followings in a 0-2 scale for a total 0-19 score. Here we will use the tenth item (sleep-wake cycle) rated on a 0-2 scale, higher scores indicating worse outcomes.
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Delirium Complications
Falls, pulling out lines, pressure ulcers, physical restraints
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Mortality
Patient death
Time frame: During the 7-day intervention