Nursing Assistant Intervention to Prevent Delirium in Nursing Homes

NCT02994979 | Completed Results DMC

• 1 other identifier: 2016-04
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Delirium

  Confusion Assessment Method (CAM)

  During acute condition, up to 3 weeks

Secondary Outcomes (3)

• Physical Function at 1 Month

  Baseline and 1 month

• Cognitive Function at 1 Month

  Baseline and 1 month

• Number of Participants Admitted to Hospital

  Up to 1 month

Study Arms (2)

Delirium-prevention group

EXPERIMENTAL

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

Usual care group

SHAM COMPARATOR

Usual care plus a sham visit from the intervention CNA

Other: Sham comparator

Interventions

Delirium-prevention OTHER

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.

Also known as: HELP-LTC

Delirium-prevention group

Sham comparator OTHER

Usual care plus sham visits by CNA

Usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Discharge or death expected before 2 months
• Nonverbal or unable to follow simple commands

Sponsors & Collaborators

• Jewish Home & Hospital Lifecare System: lead

Study Sites (1)

The New Jewish Home

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Kenneth Boockvar
• Organization: The New Jewish Home

kenneth.boockvar@mssm.edu

212-870-5062

Study Officials

• Kenneth Boockvar, MD

  Mount Sinai School of Medicine; The New Jewish Home

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 16, 2016
• Study Start: November 1, 2016
• Primary Completion: August 21, 2018
• Study Completion: August 28, 2018
• Last Updated: November 4, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-10

Locations

US (1)