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Nursing Assistant Intervention to Prevent Delirium in Nursing Homes

Multicomponent Intervention to Prevent Delirium in Nursing Homes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02994979
Enrollment
219
Registered
2016-12-16
Start date
2016-11-30
Completion date
2018-08-28
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

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.

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.

Interventions

OTHERDelirium-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.

OTHERSham comparator

Usual care plus sham visits by CNA

Sponsors

Jewish Home & Hospital Lifecare System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With DeliriumDuring acute condition, up to 3 weeksConfusion Assessment Method (CAM)

Secondary

MeasureTime frameDescription
Physical Function at 1 MonthBaseline and 1 monthMinimum 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
Cognitive Function at 1 MonthBaseline and 1 monthMinimum 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
Number of Participants Admitted to HospitalUp to 1 month

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
114
Usual Care Group
Usual care plus a sham visit from the intervention CNA Sham comparator: Usual care plus sham visits by CNA
105
Total219

Baseline characteristics

CharacteristicDelirium-prevention GroupUsual Care GroupTotal
Age, Continuous82.67 years
STANDARD_DEVIATION 1.54
80.64 years
STANDARD_DEVIATION 1.34
81.69 years
STANDARD_DEVIATION 1.1
Cognitive function7.95 units on a scale
STANDARD_DEVIATION 0.49
9.70 units on a scale
STANDARD_DEVIATION 0.44
8.79 units on a scale
STANDARD_DEVIATION 0.44
Ethnicity (NIH/OMB)
Hispanic or Latino
40 Participants25 Participants65 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
74 Participants80 Participants154 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
50 Participants47 Participants97 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
59 Participants58 Participants117 Participants
Sex: Female, Male
Female
72 Participants71 Participants143 Participants
Sex: Female, Male
Male
42 Participants34 Participants76 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
6 / 1148 / 105
other
Total, other adverse events
30 / 11416 / 105
serious
Total, serious adverse events
18 / 11419 / 105

Outcome results

Primary

Number of Participants With Delirium

Confusion Assessment Method (CAM)

Time frame: During acute condition, up to 3 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Delirium-prevention GroupNumber of Participants With Delirium41 Participants
Usual Care GroupNumber of Participants With Delirium33 Participants
Secondary

Cognitive Function at 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

Time frame: Baseline and 1 month

ArmMeasureValue (MEAN)Dispersion
Delirium-prevention GroupCognitive Function at 1 Month2.06 units on a scaleStandard Error 0.2
Usual Care GroupCognitive Function at 1 Month1.47 units on a scaleStandard Error 0.13
Secondary

Number of Participants Admitted to Hospital

Time frame: Up to 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Delirium-prevention GroupNumber of Participants Admitted to Hospital18 Participants
Usual Care GroupNumber of Participants Admitted to Hospital19 Participants
Secondary

Physical Function at 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

Time frame: Baseline and 1 month

ArmMeasureValue (MEAN)Dispersion
Delirium-prevention GroupPhysical Function at 1 Month16.05 units on a scaleStandard Error 1.13
Usual Care GroupPhysical Function at 1 Month14.27 units on a scaleStandard Error 1.23

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026