Nursing Assistant Intervention to Prevent Delirium in Nursing Homes
Primary Purpose
Delirium
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delirium-prevention
Sham comparator
Sponsored by
About this trial
This is an interventional prevention trial for Delirium
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
Sites / Locations
- The New Jewish Home
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Delirium-prevention group
Usual care group
Arm Description
Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.
Usual care plus a sham visit from the intervention CNA
Outcomes
Primary Outcome Measures
Number of Participants With Delirium
Confusion Assessment Method (CAM)
Secondary Outcome Measures
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
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
Number of Participants Admitted to Hospital
Full Information
NCT ID
NCT02994979
First Posted
December 9, 2016
Last Updated
October 15, 2019
Sponsor
Jewish Home & Hospital Lifecare System
1. Study Identification
Unique Protocol Identification Number
NCT02994979
Brief Title
Nursing Assistant Intervention to Prevent Delirium in Nursing Homes
Official Title
Multicomponent Intervention to Prevent Delirium in Nursing Homes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 21, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jewish Home & Hospital Lifecare System
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delirium-prevention group
Arm Type
Experimental
Arm Description
Multicomponent delirium prevention intervention led by a Certified Nursing Assistant (CNA) adapted for the long-term care setting from the Hospital Elder Life Program.
Arm Title
Usual care group
Arm Type
Sham Comparator
Arm Description
Usual care plus a sham visit from the intervention CNA
Intervention Type
Other
Intervention Name(s)
Delirium-prevention
Other Intervention Name(s)
HELP-LTC
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham comparator
Intervention Description
Usual care plus sham visits by CNA
Primary Outcome Measure Information:
Title
Number of Participants With Delirium
Description
Confusion Assessment Method (CAM)
Time Frame
During acute condition, up to 3 weeks
Secondary Outcome Measure Information:
Title
Physical Function at 1 Month
Description
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
Title
Cognitive Function at 1 Month
Description
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
Title
Number of Participants Admitted to Hospital
Time Frame
Up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Boockvar, MD
Organizational Affiliation
Mount Sinai School of Medicine; The New Jewish Home
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New Jewish Home
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
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Nursing Assistant Intervention to Prevent Delirium in Nursing Homes
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