Nursing Assistant Intervention to Prevent Delirium in Nursing Homes

• Sponsor: Jewish Home & Hospital Lifecare System (Other)
• Overall Status: Completed
• CT.gov ID: NCT02994979
• Collaborator: (none)
• Enrollment: 219
• Location: 1
• Arms: 2
• Duration (Months): 21.8
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

Delirium is an acute confusion that occurs in one third of hospitalized older adults. As compared to those without delirium, hospitalized patients with delirium have longer hospital stays, higher mortality, and increased risk of nursing home utilization. Substantial attention has been paid to developing, testing, and disseminating interventions to prevent delirium in the hospital but, to date, not in the nursing home setting. In a previous study we used known information on delirium risk factors to develop an intervention that can be delivered at onset of acute illness in nursing home patients. The current study is designed to test the effect of this intervention in a single-site clinical trial. Objectives: 1) to determine, as compared to control, the effect of a multicomponent intervention targeting delirium risk factors on delirium frequency, delirium severity, cognitive and physical function decline, and hospitalization in nursing home patients with acute illness, and 2) to identify features of the intervention associated with occurrence of delirium and other outcomes. Approach: We will screen nursing home patients on 17 long-term care units at a large, urban nursing home who experience onset of a change in condition according to established criteria, and enroll and assign them to intervention or control in a 1:1 ratio. Those assigned to intervention will receive daily visits from an Elder Life Specialist, a mobile Certified Nursing Assistant trained to provide services to counter risks for delirium, including dehydration, immobility, cognitive impairment, undernutrition, and sleep problems, for the duration of the acute illness and for 1 week following. Patients assigned to control will receive usual care from the unit-based nurses and the patient's primary team. Delirium will be assessed 5 days a week by a research assistant. Cognitive and physical function decline and hospital transfer will be ascertained during a 1 month follow-up period. We will compare outcomes between intervention and control, as well as examine associations between outcomes and intervention features such as number and duration of visits.

Condition or Disease	Intervention/Treatment	Phase
Delirium	Other: Delirium-prevention; Other: Sham comparator	N/A

Detailed Description

Delirium is an acute cognitive disorder with features of inattention, disorganized thinking, and disordered consciousness that occurs in one third of hospitalized older adults. As compared to those without delirium, hospitalized patients with delirium have longer hospital stays, higher mortality, and increased risk of nursing home utilization. Substantial attention has been paid to developing, testing, and disseminating interventions to prevent delirium in the hospital but, to date, not in the nursing home setting. In a previous study we used known information on delirium risk factors to develop a multicomponent intervention that can be delivered at onset of acute illness in nursing home patients. We demonstrated the intervention's feasibility, adherence, and acceptance by patients and staff. The current study is designed to test the efficacy of this intervention in a single-site cluster-randomized trial. Objectives: 1) to determine, as compared to control, the effect of a multicomponent intervention targeting delirium risk factors (immobility, cognitive impairment, dehydration, undernutrition, sleep, and medication use) on the primary outcome of delirium frequency in nursing home patients with acute illness, and the secondary outcomes of delirium severity, cognitive and physical function decline, and hospitalization associated with acute illness, and 2) to identify features of the intervention, including "dose" and components, associated with occurrence of delirium and its severity, cognitive and physical function decline, and hospitalization associated with acute illness. Approach: We will screen nursing home patients on 17 long-term care units at a large, urban nursing home who experience onset of an acute change in condition according to established criteria, and enroll and assign them to intervention or control in a 1:1 ratio. Those assigned to intervention will receive daily visits from an Elder Life Specialist, a mobile Certified Nursing Assistant trained to provide services to counter risks for delirium, including dehydration, immobility, cognitive impairment, undernutrition, and sleep problems, for the duration of the acute illness and for 1 week following, in collaboration with the patient's primary medical and nursing team. Patients assigned to control will receive usual care from the unit-based nurses and the patient's primary team. Delirium will be assessed 5 days a week by a research assistant blinded to study hypotheses and group assignment. Cognitive and physical function decline and hospital transfer will be ascertained during a 1 month follow-up period. We will conduct analyses to compare outcomes between intervention and control, as well as examine associations between outcomes and intervention features such as number and duration of visits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 219 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Multicomponent Intervention to Prevent Delirium in Nursing Homes
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Aug 21, 2018
• Actual Study Completion Date: Aug 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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 weekly intervention staff meetings patients will be discussed with the primary medical and nursing team. The planned intervention group sample size results in a case load of 4-8 patients.; Other Names: HELP-LTC
Sham Comparator: Usual care group Usual care plus a sham visit from the intervention CNA	Other: Sham comparator; Usual care plus sham visits by CNA

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Delirium [During acute condition, up to 3 weeks]

   Confusion Assessment Method (CAM)

Secondary Outcome Measures

1. Physical Function at 1 Month [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

2. Cognitive Function at 1 Month [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

3. Number of Participants Admitted to Hospital [Up to 1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Long-term care nursing home resident at The New Jewish Home

• Acute change in condition or just returned from the hospital

• Assent to participate in study

Exclusion Criteria

• Discharge or death expected before 2 months

• Nonverbal or unable to follow simple commands

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The New Jewish Home	New York	New York	United States	10025

Sponsors and Collaborators

• Jewish Home & Hospital Lifecare System

Investigators

• Principal Investigator: Kenneth Boockvar, MD, Mount Sinai School of Medicine; The New Jewish Home

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 11, 2014

More Information

Publications

None provided.

• Responsible Party: Jewish Home & Hospital Lifecare System
• ClinicalTrials.gov Identifier: NCT02994979
• Other Study ID Numbers: 2016-04
• First Posted: Dec 16, 2016
• Last Update Posted: Nov 4, 2019
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Delirium

Study Results

Participant Flow

Arm/Group Title	Delirium-prevention Group	Usual Care Group
Arm/Group Description	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 plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Period Title: Overall Study
STARTED	114	105
COMPLETED	114	105
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Delirium-prevention Group	Usual Care Group	Total
Arm/Group Description	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 plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA	Total of all reporting groups
Overall Participants	114	105	219
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	82.67 (1.54)	80.64 (1.34)	81.69 (1.10)
Sex: Female, Male (Count of Participants)
Female	72 63.2%	71 67.6%	143 65.3%
Male	42 36.8%	34 32.4%	76 34.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	40 35.1%	25 23.8%	65 29.7%
Not Hispanic or Latino	74 64.9%	80 76.2%	154 70.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 2.6%	0 0%	3 1.4%
Native Hawaiian or Other Pacific Islander	2 1.8%	0 0%	2 0.9%
Black or African American	50 43.9%	47 44.8%	97 44.3%
White	59 51.8%	58 55.2%	117 53.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Cognitive function (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.95 (.49)	9.70 (.44)	8.79 (.44)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Delirium
Description	Confusion Assessment Method (CAM)
Time Frame	During acute condition, up to 3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delirium-prevention Group	Usual Care Group
Arm/Group Description	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 plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Measure Participants	114	105
Count of Participants [Participants]	41 36%	33 31.4%

2. Secondary Outcome

Title	Physical Function at 1 Month
Description	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
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delirium-prevention Group	Usual Care Group
Arm/Group Description	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 plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Measure Participants	114	105
Mean (Standard Error) [units on a scale]	16.05 (1.13)	14.27 (1.23)

3. Secondary Outcome

Title	Cognitive Function at 1 Month
Description	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
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delirium-prevention Group	Usual Care Group
Arm/Group Description	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 plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Measure Participants	114	105
Mean (Standard Error) [units on a scale]	2.06 (.20)	1.47 (.13)

4. Secondary Outcome

Title	Number of Participants Admitted to Hospital
Time Frame	Up to 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delirium-prevention Group	Usual Care Group
Arm/Group Description	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 plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
Measure Participants	114	105
Count of Participants [Participants]	18 15.8%	19 18.1%

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	Fall
Arm/Group Title	Delirium-prevention Group		Usual Care Group
Arm/Group Description	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 plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
All Cause Mortality
	Delirium-prevention Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/114 (5.3%)		8/105 (7.6%)
Serious Adverse Events
	Delirium-prevention Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/114 (15.8%)		19/105 (18.1%)
General disorders
Hospital admission	18/114 (15.8%)	22	19/105 (18.1%)	19
Other (Not Including Serious) Adverse Events
	Delirium-prevention Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/114 (26.3%)		16/105 (15.2%)
General disorders
Fall	30/114 (26.3%)	47	16/105 (15.2%)	26

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.