Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nursing Assistant Intervention to Prevent Delirium in Nursing Homes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02994979
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Jewish Home & Hospital Lifecare System

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Delirium incidence [ Time Frame: During acute condition, an average of 2 weeks ]
    Confusion Assessment Method (CAM)


Secondary Outcome Measures :
  1. Change in physical function at 1 month [ Time Frame: Baseline and 1 month ]
    Minimum Data Set Activities of Daily Living scale

  2. Change in cognitive function at 1 month [ Time Frame: Baseline and 1 month ]
    Minimum Data Set Cognitive Performance Scale

  3. Hospital admission [ Time Frame: Up to 1 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994979


Locations
Layout table for location information
United States, New York
The New Jewish Home
New York, New York, United States, 10025
Sponsors and Collaborators
Jewish Home & Hospital Lifecare System
Investigators
Layout table for investigator information
Principal Investigator: Kenneth Boockvar, MD Mount Sinai School of Medicine; The New Jewish Home

Layout table for additonal information
Responsible Party: Jewish Home & Hospital Lifecare System
ClinicalTrials.gov Identifier: NCT02994979     History of Changes
Other Study ID Numbers: 2016-04
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders