Delirium Treatment With Acupuncture in Internal Medicine Departments

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

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.

Study Overview

• Status: Completed
• Conditions: Delirium in Old Age
• Intervention / Treatment: Other: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Golomb 47
    • Haifa, Golomb 47, Israel, 3104802
      • Bnai Zion Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; Acupuncture for delirium treatment	Other: Acupuncture; Acupuncture added to usual care
No Intervention: Standard care; Standard conventional delirium care at the discretion of the department medical staff

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Publications and helpful links

General Publications

• Levy I, Gavrieli S, Hefer T, Attias S, Schiff A, Oliven R, Wisberg-Levi S, Hanchinsky R, Schiff E. Acupuncture Treatment of Delirium in Older Adults Hospitalized in Internal Medicine Departments: An Open-Label Pragmatic Randomized-Controlled Trial. J Geriatr Psychiatry Neurol. 2022 May;35(3):333-343. doi: 10.1177/0891988721996804. Epub 2021 Mar 9.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: December 31, 2017
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: August 30, 2020
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 0102-14-BNZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No