Delirium Treatment With Acupuncture in Internal Medicine Departments

Not Applicable

Completed

Conditions: Delirium in Old Age

Interventions: Other: Acupuncture

Registration Number: NCT03398928

Lead Sponsor: Bnai Zion Medical Center

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

Inclusion Criteria

Hospitalized in internal medicine department
Aged over 65 years
Delirium or subsyndromal delirium within the last 48 hours

Exclusion Criteria

Platelet count under 20x10^9/L
Encephalopathy explained by a cause other than delirium (acute stroke, alcohol, cirrhosis, etc.)
History of severe dementia
Communication barriers preventing delirium assessment

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	Acupuncture for delirium treatment

Primary Outcome Measures

Name	Time	Method
Time-to-first Remission of Delirium in the 7 Days of Evaluation	At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7 of the study	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).
Number of Delirium-free Days During the 7 Days of Evaluation	At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study	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).

Secondary Outcome Measures

Name	Time	Method
Visual Assessment Scale (VAS) for Pain	At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study	Daily Visual Assesment Scale - This scale measures pain in a 0-10 score. Higher scores indicate worse pain.
Number of Days in Which Antipsychotic Drugs Were Used	At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study	Daily patient chart review for antipsychotic drugs
Sleep	At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study	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.
Delirium Severity	Sum of CAM-S at day 2 + day 3 + day 4 + day 5 + day 6 + day 7 of the study	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).
Delirium Complications	At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study	Falls, pulling out lines, pressure ulcers, physical restraints
Mortality	During the 7-day intervention	Patient death
Functional Status at Discharge	Through study completion, an average of 2-3 weeks	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.
Length of Hospital Stay	Through study completion, an average of 2-3 weeks	Days of hospitalization