DeliriumNCT02994979
Nursing Assistant Intervention to Prevent Delirium in Nursing Homes
A study testing Delirium-prevention in people with Delirium, run by Jewish Home & Hospital Lifecare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Delirium-prevention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 28 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Discharge or death expected before 2 months
- Nonverbal or unable to follow simple commands
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicomponent Intervention to Prevent Delirium in Nursing Homes
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.
Read the 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.
- Conditions
- Delirium
- Being tested
- Delirium-prevention, Sham comparator
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delirium-preventionOther
Also called HELP-LTC
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.
Sham comparatorOther
Usual care plus sham visits by CNA
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Delirium-prevention |
| Usual care group | Sham comparator | Usual care plus a sham visit from the intervention CNA Receives: Other: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Delirium
Confusion Assessment Method (CAM)
Measured: During acute condition, up to 3 weeks
Secondary outcomes (3)
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
Measured: Baseline and 1 month
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
Measured: Baseline and 1 month
Number of Participants Admitted to Hospital
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion21 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish Home & Hospital Lifecare System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Boockvar, MD, Principal investigator, Mount Sinai School of Medicine; The New Jewish Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994979
- Sponsor's protocol ID
- 2016-04
- Status last verified
- Oct 2019
- First submitted
- 9 Dec 2016
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Intervention to Prevent Delirium in Nursing Homes
- ClinicalTrials.gov ID
- NCT02994979
- Acronym / sponsor ID
- 2016-04
- Conditions
- Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Jewish Home & Hospital Lifecare SystemUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium-prevention group | Experimental | Other: Delirium-preventionMulticomponent 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 group | Sham comparator | Other: Sham comparatorUsual care plus a sham visit from the intervention CNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Discharge or death expected before 2 months
- Nonverbal or unable to follow simple commands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delirium-preventionAlso: HELP-LTCPatients 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 | Delirium-prevention group |
| Sham comparatorUsual care plus sham visits by CNA | Other | Usual care group |
Primary outcome
Number of Participants With Delirium
Time frame: During acute condition, up to 3 weeks
Confusion Assessment Method (CAM)
3 secondary outcomes
Physical Function at 1 Month
Time frame: Baseline and 1 month
Cognitive Function at 1 Month
Time frame: Baseline and 1 month
Number of Participants Admitted to Hospital
Time frame: Up to 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
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Lactium Premedication to Prevent Emergence Agitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Boockvar, MD principal investigator
Mount Sinai School of Medicine; The New Jewish Home
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delirium-prevention in people with Delirium, run by Jewish Home & Hospital Lifecare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Delirium (time frame: During acute condition, up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.