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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Acupuncture for delirium treatment |
|
| Standard care | No Intervention | Standard conventional delirium care at the discretion of the department medical staff |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Acupuncture added to usual care |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elad Schiff, M.D. | Bnai Zion Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Medical Center | Haifa | Golomb 47 | 3104802 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33685268 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | Acupuncture for delirium treatment Acupuncture + Standard care |
| FG001 | Standard Care | Standard conventional delirium care at the discretion of the department medical staff |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | Acupuncture for delirium treatment Acupuncture + Standard care |
| BG001 | Standard Care | Standard conventional delirium care at the discretion of the department medical staff |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Full Range | days | At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | Acupuncture for delirium treatment Acupuncture + Standard care | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Elad Schiff | Bnai Zion Medical Center | 972-506267243 | elad.schiff@b-zion.org.il |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2020 | Jul 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Long CAM-Severity (minimum: 0, better prognosis; maximum: 19, worse prognosis) | Median | Full Range | units on a scale |
|
| Standard Care |
Standard conventional delirium care at the discretion of the department medical staff |
|
|
|
| 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). | Posted | Median | Full Range | days | At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7 of the study |
|
|
|
|
| Secondary | Length of Hospital Stay | Days of hospitalization | Posted | Mean | Standard Deviation | days | Through study completion, an average of 2-3 weeks |
|
|
|
| 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. | Posted | Median | Full Range | units on a scale | Through study completion, an average of 2-3 weeks |
|
|
|
| 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). | Long CAM-S sum was missing for some participants (5 in the acupuncture arm, and 3 in the standard care arm) | Posted | Count of Participants | Participants | Sum of CAM-S at day 2 + day 3 + day 4 + day 5 + day 6 + day 7 of the study |
|
|
|
|
| Secondary | Number of Days in Which Antipsychotic Drugs Were Used | Daily patient chart review for antipsychotic drugs | Posted | Median | Full Range | days | At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study |
|
|
|
|
| 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. | Posted | Median | Full Range | units on a scale | At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study |
|
|
|
| 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. | Posted | Median | Full Range | units on a scale | At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study |
|
|
|
| Secondary | Delirium Complications | Falls, pulling out lines, pressure ulcers, physical restraints | Posted | Count of Participants | Participants | At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study |
|
|
|
| Secondary | Mortality | Patient death | Posted | Count of Participants | Participants | During the 7-day intervention |
|
|
|
| 50 |
| 0 |
| 50 |
| 9 |
| 50 |
| EG001 | Standard Care | Standard conventional delirium care at the discretion of the department medical staff | 0 | 31 | 0 | 31 | 7 | 31 |
| Pulling-out IV lines | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pulling-out urinary catheter | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pressure ulcers worsening | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Need for physical restraints due to extreme agitation | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| Moderate severity (Long CAM-S sum = 7-13) |
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| High severity (Long CAM-S sum >= 14) |
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Pulling-out IV lines |
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| Pulling-out urinary catheter |
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| Pressure ulcers worsening |
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