Delirium in Old Age
Conditions
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.
Interventions
OTHERAcupuncture
Acupuncture added to usual care
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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. |
| Length of Hospital Stay | Through study completion, an average of 2-3 weeks | Days of hospitalization |
| 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 |
| 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. |
| 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. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture Acupuncture for delirium treatment
Acupuncture + Standard care | 50 |
| Standard Care Standard conventional delirium care at the discretion of the department medical staff | 31 |
| Total | 81 |
Baseline characteristics
| Characteristic | Total | Acupuncture | Standard Care |
|---|---|---|---|
| Age, Continuous | 84 years STANDARD_DEVIATION 6.5 | 84 years STANDARD_DEVIATION 7.8 | 85.3 years STANDARD_DEVIATION 6.7 |
| Long CAM-Severity (minimum: 0, better prognosis; maximum: 19, worse prognosis) | 8 units on a scale | 8 units on a scale | 9 units on a scale |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 37 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Male | 44 Participants | 25 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 31 |
| other Total, other adverse events | 9 / 50 | 7 / 31 |
| serious Total, serious adverse events | 0 / 50 | 0 / 31 |
Outcome results
Primary
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).
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Number of Delirium-free Days During the 7 Days of Evaluation | 5.5 days |
| Standard Care | Number of Delirium-free Days During the 7 Days of Evaluation | 0 days |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
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).
Time frame: At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7 of the study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Time-to-first Remission of Delirium in the 7 Days of Evaluation | 1 days |
| Standard Care | Time-to-first Remission of Delirium in the 7 Days of Evaluation | 7 days |
p-value: <0.001Log Rank
Secondary
Delirium Complications
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Acupuncture | Delirium Complications | Need for physical restraints due to agitation | 5 Participants |
| Acupuncture | Delirium Complications | Pulling-out urinary catheter | 1 Participants |
| Acupuncture | Delirium Complications | Pulling-out IV lines | 3 Participants |
| Acupuncture | Delirium Complications | Pressure ulcers worsening | 1 Participants |
| Acupuncture | Delirium Complications | Fall | 1 Participants |
| Standard Care | Delirium Complications | Pressure ulcers worsening | 1 Participants |
| Standard Care | Delirium Complications | Fall | 1 Participants |
| Standard Care | Delirium Complications | Need for physical restraints due to agitation | 5 Participants |
| Standard Care | Delirium Complications | Pulling-out IV lines | 2 Participants |
| Standard Care | Delirium Complications | Pulling-out urinary catheter | 1 Participants |
Secondary
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).
Time frame: 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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Acupuncture | Delirium Severity | No delirium (Long CAM-S sum = 0-3) | 11 Participants |
| Acupuncture | Delirium Severity | Low severity (Long CAM-S sum = 4-6) | 6 Participants |
| Acupuncture | Delirium Severity | Moderate severity (Long CAM-S sum = 7-13) | 9 Participants |
| Acupuncture | Delirium Severity | High severity (Long CAM-S sum >= 14) | 19 Participants |
| Standard Care | Delirium Severity | High severity (Long CAM-S sum >= 14) | 24 Participants |
| Standard Care | Delirium Severity | No delirium (Long CAM-S sum = 0-3) | 3 Participants |
| Standard Care | Delirium Severity | Moderate severity (Long CAM-S sum = 7-13) | 1 Participants |
| Standard Care | Delirium Severity | Low severity (Long CAM-S sum = 4-6) | 0 Participants |
p-value: 0.002Chi-squared
Secondary
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.
Time frame: Through study completion, an average of 2-3 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Functional Status at Discharge | 2 units on a scale |
| Standard Care | Functional Status at Discharge | 3.5 units on a scale |
Secondary
Length of Hospital Stay
Days of hospitalization
Time frame: Through study completion, an average of 2-3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Length of Hospital Stay | 16.4 days | Standard Deviation 14.7 |
| Standard Care | Length of Hospital Stay | 18.3 days | Standard Deviation 15 |
Secondary
Mortality
Patient death
Time frame: During the 7-day intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acupuncture | Mortality | 0 Participants |
| Standard Care | Mortality | 0 Participants |
Secondary
Number of Days in Which Antipsychotic Drugs Were Used
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupuncture | Number of Days in Which Antipsychotic Drugs Were Used | 7 days |
| Standard Care | Number of Days in Which Antipsychotic Drugs Were Used | 7 days |
p-value: 0.253Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Acupuncture | Sleep | Day 4 | 0 units on a scale |
| Acupuncture | Sleep | Day 5 | 0 units on a scale |
| Acupuncture | Sleep | Day 6 | 0 units on a scale |
| Acupuncture | Sleep | Day 7 | 0 units on a scale |
| Acupuncture | Sleep | Day 1 | 1 units on a scale |
| Acupuncture | Sleep | Day 2 | 0 units on a scale |
| Acupuncture | Sleep | Day 3 | 0 units on a scale |
| Standard Care | Sleep | Day 7 | 0 units on a scale |
| Standard Care | Sleep | Day 4 | 0 units on a scale |
| Standard Care | Sleep | Day 1 | 1 units on a scale |
| Standard Care | Sleep | Day 5 | 0 units on a scale |
| Standard Care | Sleep | Day 3 | 0 units on a scale |
| Standard Care | Sleep | Day 6 | 0 units on a scale |
| Standard Care | Sleep | Day 2 | 1 units on a scale |
Secondary
Visual Assessment Scale (VAS) for Pain
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Acupuncture | Visual Assessment Scale (VAS) for Pain | Day 7 | 0 units on a scale |
| Acupuncture | Visual Assessment Scale (VAS) for Pain | Day 2 | 0 units on a scale |
| Acupuncture | Visual Assessment Scale (VAS) for Pain | Day 3 | 0 units on a scale |
| Acupuncture | Visual Assessment Scale (VAS) for Pain | Day 4 | 0 units on a scale |
| Acupuncture | Visual Assessment Scale (VAS) for Pain | Day 5 | 0 units on a scale |
| Acupuncture | Visual Assessment Scale (VAS) for Pain | Day 6 | 0 units on a scale |
| Acupuncture | Visual Assessment Scale (VAS) for Pain | Day 1 | 0 units on a scale |
| Standard Care | Visual Assessment Scale (VAS) for Pain | Day 5 | 0 units on a scale |
| Standard Care | Visual Assessment Scale (VAS) for Pain | Day 1 | 0 units on a scale |
| Standard Care | Visual Assessment Scale (VAS) for Pain | Day 4 | 0 units on a scale |
| Standard Care | Visual Assessment Scale (VAS) for Pain | Day 6 | 0 units on a scale |
| Standard Care | Visual Assessment Scale (VAS) for Pain | Day 7 | 0 units on a scale |
| Standard Care | Visual Assessment Scale (VAS) for Pain | Day 2 | 0 units on a scale |
| Standard Care | Visual Assessment Scale (VAS) for Pain | Day 3 | 0 units on a scale |