Nursing Assistant Intervention to Prevent Delirium in Nursing Homes

• ClinicalTrials.gov Identifier: NCT02994979
• Recruitment Status: Completed
• First Posted: December 16, 2016
• Results First Posted: November 4, 2019
• Last Update Posted: November 4, 2019
• Sponsor: Jewish Home & Hospital Lifecare System
• Information provided by (Responsible Party): Jewish Home & Hospital Lifecare System

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	Not Applicable

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 (Clinical Trial)
• 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: November 2016
• Actual Primary Completion Date: August 21, 2018
• Actual Study Completion Date: August 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 Name: 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 [ Time Frame: During acute condition, up to 3 weeks ]
   Confusion Assessment Method (CAM)

Secondary Outcome Measures :

1. Physical Function at 1 Month [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 1 month ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

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)

Documents provided by Jewish Home & Hospital Lifecare System:

Study Protocol and Statistical Analysis Plan  [PDF] November 11, 2014

More Information

• Responsible Party: Jewish Home & Hospital Lifecare System
• ClinicalTrials.gov Identifier: NCT02994979
• Other Study ID Numbers: 2016-04
• First Posted: December 16, 2016
• Results First Posted: November 4, 2019
• Last Update Posted: November 4, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders