Trial Outcomes & Findings for Delirium Treatment With Acupuncture in Internal Medicine Departments (NCT NCT03398928)

NCT ID: NCT03398928

Last Updated: 2020-09-18

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 81 participants
• Primary outcome timeframe: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
• Results posted on: 2020-09-18

Participant Flow

Participant milestones

Measure	Acupuncture Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care Standard conventional delirium care at the discretion of the department medical staff
Overall Study STARTED	50	31
Overall Study COMPLETED	50	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff	Total n=81 Participants Total of all reporting groups
Age, Continuous	84 years STANDARD_DEVIATION 7.8 • n=50 Participants	85.3 years STANDARD_DEVIATION 6.7 • n=31 Participants	84 years STANDARD_DEVIATION 6.5 • n=81 Participants
Sex: Female, Male Female	25 Participants n=50 Participants	12 Participants n=31 Participants	37 Participants n=81 Participants
Sex: Female, Male Male	25 Participants n=50 Participants	19 Participants n=31 Participants	44 Participants n=81 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Long CAM-Severity (minimum: 0, better prognosis; maximum: 19, worse prognosis)	8 units on a scale n=50 Participants	9 units on a scale n=31 Participants	8 units on a scale n=81 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff
Number of Delirium-free Days During the 7 Days of Evaluation	5.5 days Interval 0.0 to 6.0	0 days Interval 0.0 to 6.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff
Time-to-first Remission of Delirium in the 7 Days of Evaluation	1 days Interval 1.0 to 7.0	7 days Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: Through study completion, an average of 2-3 weeks

Days of hospitalization

Outcome measures

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff
Length of Hospital Stay	16.4 days Standard Deviation 14.7	18.3 days Standard Deviation 15

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff
Functional Status at Discharge	2 units on a scale Interval 0.0 to 6.0	3.5 units on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: Sum of CAM-S at day 2 + day 3 + day 4 + day 5 + day 6 + day 7 of the study

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

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).

Outcome measures

Measure	Acupuncture n=45 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=28 Participants Standard conventional delirium care at the discretion of the department medical staff
Delirium Severity No delirium (Long CAM-S sum = 0-3)	11 Participants	3 Participants
Delirium Severity Low severity (Long CAM-S sum = 4-6)	6 Participants	0 Participants
Delirium Severity Moderate severity (Long CAM-S sum = 7-13)	9 Participants	1 Participants
Delirium Severity High severity (Long CAM-S sum >= 14)	19 Participants	24 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff
Number of Days in Which Antipsychotic Drugs Were Used	7 days Interval 0.0 to 7.0	7 days Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff
Visual Assessment Scale (VAS) for Pain Day 1	0 units on a scale Interval 0.0 to 10.0	0 units on a scale Interval 0.0 to 5.0
Visual Assessment Scale (VAS) for Pain Day 2	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 0.0
Visual Assessment Scale (VAS) for Pain Day 3	0 units on a scale Interval 0.0 to 5.0	0 units on a scale Interval 0.0 to 5.0
Visual Assessment Scale (VAS) for Pain Day 4	0 units on a scale Interval 0.0 to 6.0	0 units on a scale Interval 0.0 to 3.0
Visual Assessment Scale (VAS) for Pain Day 5	0 units on a scale Interval 0.0 to 6.0	0 units on a scale Interval 0.0 to 4.0
Visual Assessment Scale (VAS) for Pain Day 6	0 units on a scale Interval 0.0 to 10.0	0 units on a scale Interval 0.0 to 5.0
Visual Assessment Scale (VAS) for Pain Day 7	0 units on a scale Interval 0.0 to 10.0	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff
Sleep Day 1	1 units on a scale Interval 0.0 to 2.0	1 units on a scale Interval 0.0 to 2.0
Sleep Day 2	0 units on a scale Interval 0.0 to 2.0	1 units on a scale Interval 0.0 to 2.0
Sleep Day 3	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 2.0
Sleep Day 4	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 0.0
Sleep Day 5	0 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 2.0
Sleep Day 6	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 2.0
Sleep Day 7	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff
Delirium Complications Fall	1 Participants	1 Participants
Delirium Complications Need for physical restraints due to agitation	5 Participants	5 Participants
Delirium Complications Pulling-out IV lines	3 Participants	2 Participants
Delirium Complications Pulling-out urinary catheter	1 Participants	1 Participants
Delirium Complications Pressure ulcers worsening	1 Participants	1 Participants

SECONDARY outcome

Timeframe: During the 7-day intervention

Patient death

Outcome measures

Measure	Acupuncture n=50 Participants Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 Participants Standard conventional delirium care at the discretion of the department medical staff
Mortality	0 Participants	0 Participants

Adverse Events

Acupuncture

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acupuncture n=50 participants at risk Acupuncture for delirium treatment Acupuncture + Standard care	Standard Care n=31 participants at risk Standard conventional delirium care at the discretion of the department medical staff
Injury, poisoning and procedural complications Fall	2.0% 1/50 • 1 week	3.2% 1/31 • 1 week
Injury, poisoning and procedural complications Pulling-out IV lines	6.0% 3/50 • 1 week	6.5% 2/31 • 1 week
Injury, poisoning and procedural complications Pulling-out urinary catheter	2.0% 1/50 • 1 week	3.2% 1/31 • 1 week
Skin and subcutaneous tissue disorders Pressure ulcers worsening	2.0% 1/50 • 1 week	3.2% 1/31 • 1 week
Injury, poisoning and procedural complications Need for physical restraints due to extreme agitation	10.0% 5/50 • 1 week	16.1% 5/31 • 1 week

Additional Information

Prof. Elad Schiff

Bnai Zion Medical Center

Phone: 972-506267243

Email: elad.schiff@b-zion.org.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place