Delirium Treatment With Acupuncture in Internal Medicine Departments

• Sponsor: Bnai Zion Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03398928
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.6
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium in Old Age	Other: Acupuncture	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Delirium Treatment With Acupuncture in Internal Medicine Departments: a Randomized Sham-controlled Clinical Trial
• Actual Study Start Date: Jan 14, 2018
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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).

Secondary Outcome Measures

1. Length of Hospital Stay [Through study completion, an average of 2-3 weeks]

   Days of hospitalization

2. 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.

3. 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).

4. 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

5. 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.

6. 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.

7. 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

8. Mortality [During the 7-day intervention]

   Patient death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bnai Zion Medical Center	Haifa	Golomb 47	Israel	3104802

Sponsors and Collaborators

• Bnai Zion Medical Center

Investigators

• Principal Investigator: Elad Schiff, M.D., Bnai Zion Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2020

More Information

Publications

None provided.

• Responsible Party: Bnai Zion Medical Center
• ClinicalTrials.gov Identifier: NCT03398928
• Other Study ID Numbers: 0102-14-BNZ
• First Posted: Jan 16, 2018
• Last Update Posted: Sep 18, 2020
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Delirium

Study Results

Participant Flow

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Period Title: Overall Study
STARTED	50	31
COMPLETED	50	31
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Acupuncture	Standard Care	Total
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff	Total of all reporting groups
Overall Participants	50	31	81
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	84 (7.8)	85.3 (6.7)	84 (6.5)
Sex: Female, Male (Count of Participants)
Female	25 50%	12 38.7%	37 45.7%
Male	25 50%	19 61.3%	44 54.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Long CAM-Severity (minimum: 0, better prognosis; maximum: 19, worse prognosis) (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	8	9	8

Outcome Measures

1. Primary Outcome

Title	Number of Delirium-free Days During the 7 Days of Evaluation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	50	31
Median (Full Range) [days]	5.5	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture, Standard Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Time-to-first Remission of Delirium in the 7 Days of Evaluation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	50	31
Median (Full Range) [days]	1	7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture, Standard Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Log Rank
	Comments

3. Secondary Outcome

Title	Length of Hospital Stay
Description	Days of hospitalization
Time Frame	Through study completion, an average of 2-3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	50	31
Mean (Standard Deviation) [days]	16.4 (14.7)	18.3 (15)

4. Secondary Outcome

Title	Functional Status at Discharge
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	50	31
Median (Full Range) [units on a scale]	2	3.5

5. Secondary Outcome

Title	Delirium Severity
Description	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

Outcome Measure Data

Analysis Population Description

Long CAM-S sum was missing for some participants (5 in the acupuncture arm, and 3 in the standard care arm)

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	45	28
No delirium (Long CAM-S sum = 0-3)	11 22%	3 9.7%
Low severity (Long CAM-S sum = 4-6)	6 12%	0 0%
Moderate severity (Long CAM-S sum = 7-13)	9 18%	1 3.2%
High severity (Long CAM-S sum >= 14)	19 38%	24 77.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture, Standard Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	The statistical analysis applies to all the rows
	Method	Chi-squared
	Comments

6. Secondary Outcome

Title	Number of Days in Which Antipsychotic Drugs Were Used
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	50	31
Median (Full Range) [days]	7	7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acupuncture, Standard Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.253
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Visual Assessment Scale (VAS) for Pain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	50	31
Day 1	0	0
Day 2	0	0
Day 3	0	0
Day 4	0	0
Day 5	0	0
Day 6	0	0
Day 7	0	0

8. Secondary Outcome

Title	Sleep
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	50	31
Day 1	1	1
Day 2	0	1
Day 3	0	0
Day 4	0	0
Day 5	0	0
Day 6	0	0
Day 7	0	0

9. Secondary Outcome

Title	Delirium Complications
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	50	31
Fall	1 2%	1 3.2%
Need for physical restraints due to agitation	5 10%	5 16.1%
Pulling-out IV lines	3 6%	2 6.5%
Pulling-out urinary catheter	1 2%	1 3.2%
Pressure ulcers worsening	1 2%	1 3.2%

10. Secondary Outcome

Title	Mortality
Description	Patient death
Time Frame	During the 7-day intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care	Standard conventional delirium care at the discretion of the department medical staff
Measure Participants	50	31
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	1 week
Arm/Group Title	Acupuncture		Standard Care
Arm/Group Description	Acupuncture for delirium treatment Acupuncture + Standard care		Standard conventional delirium care at the discretion of the department medical staff
All Cause Mortality
	Acupuncture		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/31 (0%)
Serious Adverse Events
	Acupuncture		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Acupuncture		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/50 (18%)		7/31 (22.6%)
Injury, poisoning and procedural complications
Fall	1/50 (2%)		1/31 (3.2%)
Pulling-out IV lines	3/50 (6%)		2/31 (6.5%)
Pulling-out urinary catheter	1/50 (2%)		1/31 (3.2%)
Need for physical restraints due to extreme agitation	5/50 (10%)		5/31 (16.1%)
Skin and subcutaneous tissue disorders
Pressure ulcers worsening	1/50 (2%)		1/31 (3.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.