Delirium Clinical Trial
Official title:
Multicomponent Intervention to Prevent Delirium in Nursing Homes
NCT number | NCT02994979 |
Other study ID # | 2016-04 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | August 28, 2018 |
Verified date | October 2019 |
Source | Jewish Home & Hospital Lifecare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 219 |
Est. completion date | August 28, 2018 |
Est. primary completion date | August 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | The New Jewish Home | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Jewish Home & Hospital Lifecare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Delirium | Confusion Assessment Method (CAM) | During acute condition, up to 3 weeks | |
Secondary | 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 | Baseline and 1 month | |
Secondary | 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 | Baseline and 1 month | |
Secondary | Number of Participants Admitted to Hospital | Up to 1 month |
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