Delirium Treatment With Acupuncture in Internal Medicine Departments

Study Overview
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Brief Summary
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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
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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.

Official Title
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Delirium Treatment With Acupuncture in Internal Medicine Departments: a Randomized Sham-controlled Clinical Trial

Conditions
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Delirium in Old Age

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture for delirium treatment | Other: Acupuncture<br>* Acupuncture added to usual care<br>|
| No Intervention: Standard care<br>Standard conventional delirium care at the discretion of the department medical staff | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7 of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Days of hospitalization | 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. | Through study completion, an average of 2-3 weeks | 
| 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). | 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 | 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. | 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. | 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 | At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study | 
| Mortality | Patient death | During the 7-day intervention |