Trial Outcomes & Findings for Nursing Assistant Intervention to Prevent Delirium in Nursing Homes (NCT NCT02994979)

NCT ID: NCT02994979

Last Updated: 2019-11-04

Results Overview

Confusion Assessment Method (CAM)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 219 participants
• Primary outcome timeframe: During acute condition, up to 3 weeks
• Results posted on: 2019-11-04

Participant Flow

Participant milestones

Measure	Delirium-prevention Group Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program. Delirium-prevention: Patients will be seen by an intervention CNA at least once daily 7 days a week. The CNA will be English/Spanish bilingual and will provide intervention components guided by structured protocols and a daily visit form. A typical visit lasts 30 minutes and begins with an introduction and orientation activity followed by provision of water, a reminiscence activity or game, a physical exercise, and a snack and second cup of water. Patients may also receive a relaxation visit at night and given a warm drink, a hand or foot massage, and quiet music. Daily visits will last for the duration of the illness and 7 days following the illness end. Illness end is defined as the last day of illness treatment (e.g., last day of antibiotics) or monitoring (e.g., last day on nursing "24-hour report"). During	Usual Care Group Usual care plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Overall Study STARTED	114	105
Overall Study COMPLETED	114	105
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nursing Assistant Intervention to Prevent Delirium in Nursing Homes

Baseline characteristics by cohort

Measure	Delirium-prevention Group n=114 Participants Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.	Usual Care Group n=105 Participants Usual care plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA	Total n=219 Participants Total of all reporting groups
Age, Continuous	82.67 years STANDARD_DEVIATION 1.54 • n=5 Participants	80.64 years STANDARD_DEVIATION 1.34 • n=7 Participants	81.69 years STANDARD_DEVIATION 1.10 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	71 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	34 Participants n=7 Participants	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants	25 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	80 Participants n=7 Participants	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	50 Participants n=5 Participants	47 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	58 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Cognitive function	7.95 units on a scale STANDARD_DEVIATION .49 • n=5 Participants	9.70 units on a scale STANDARD_DEVIATION .44 • n=7 Participants	8.79 units on a scale STANDARD_DEVIATION .44 • n=5 Participants

PRIMARY outcome

Timeframe: During acute condition, up to 3 weeks

Confusion Assessment Method (CAM)

Outcome measures

Measure	Delirium-prevention Group n=114 Participants Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.	Usual Care Group n=105 Participants Usual care plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Number of Participants With Delirium	41 Participants	33 Participants

SECONDARY outcome

Timeframe: Baseline and 1 month

Minimum Data Set Activities of Daily Living scale; Scale range = 0-28; Higher score = Worse activities of daily living function; Outcome measure at 1 month may be adjusted for outcome measure at baseline

Outcome measures

Measure	Delirium-prevention Group n=114 Participants Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.	Usual Care Group n=105 Participants Usual care plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Physical Function at 1 Month	16.05 units on a scale Standard Error 1.13	14.27 units on a scale Standard Error 1.23

SECONDARY outcome

Timeframe: Baseline and 1 month

Minimum Data Set Cognitive Performance Scale; Scale range = 0-6; Higher scores = Worse cognitive performance; Outcome measure at 1 month may be adjusted for outcome measure at baseline

Outcome measures

Measure	Delirium-prevention Group n=114 Participants Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.	Usual Care Group n=105 Participants Usual care plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Cognitive Function at 1 Month	2.06 units on a scale Standard Error .20	1.47 units on a scale Standard Error .13

SECONDARY outcome

Timeframe: Up to 1 month

Outcome measures

Measure	Delirium-prevention Group n=114 Participants Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.	Usual Care Group n=105 Participants Usual care plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Number of Participants Admitted to Hospital	18 Participants	19 Participants

Adverse Events

Delirium-prevention Group

Serious events: 18 serious events

Other events: 30 other events

Deaths: 6 deaths

Usual Care Group

Serious events: 19 serious events

Other events: 16 other events

Deaths: 8 deaths

Serious adverse events

Measure	Delirium-prevention Group n=114 participants at risk Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.	Usual Care Group n=105 participants at risk Usual care plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
General disorders Hospital admission	15.8% 18/114 • Number of events 22 • 30 days Fall	18.1% 19/105 • Number of events 19 • 30 days Fall

Other adverse events

Measure	Delirium-prevention Group n=114 participants at risk Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.	Usual Care Group n=105 participants at risk Usual care plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
General disorders Fall	26.3% 30/114 • Number of events 47 • 30 days Fall	15.2% 16/105 • Number of events 26 • 30 days Fall

Additional Information

Dr. Kenneth Boockvar

The New Jewish Home

Phone: 212-870-5062

Email: kenneth.boockvar@mssm.edu

Results disclosure agreements

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