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N/A N=219 Randomized Triple-blind Prevention

Nursing Assistant Intervention to Prevent Delirium in Nursing Homes

Delirium

Enrolled (actual)
219
Serious AEs
16.9%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Delirium — 41; 33 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Delirium-prevention (Other); Sham comparator (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Jewish Home & Hospital Lifecare System
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Delirium
41; 33
SECONDARY
Physical Function at 1 Month
16.05; 14.27
SECONDARY
Cognitive Function at 1 Month
2.06; 1.47
SECONDARY
Number of Participants Admitted to Hospital
18; 19

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02994979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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