Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias
Status: | Recruiting |
---|---|
Conditions: | Alzheimer Disease, Infectious Disease, Neurology |
Therapuetic Areas: | Immunology / Infectious Diseases, Neurology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 2/28/2019 |
Start Date: | October 15, 2017 |
End Date: | March 2021 |
Contact: | Susan L Mitchell, MD, MPH |
Email: | smitchell@hsl.harvard.edu |
Phone: | 617-281-3669 |
Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (TRAIN-AD)
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data
analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an
intervention to improve infection management for suspected UTIs and LRIs among residents with
advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of
randomization as the intervention must be delivered at the facility level to avoid
contamination and because this is how it would be employed in the real-world. Analyses will
be at the patient level.
analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an
intervention to improve infection management for suspected UTIs and LRIs among residents with
advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of
randomization as the intervention must be delivered at the facility level to avoid
contamination and because this is how it would be employed in the real-world. Analyses will
be at the patient level.
The final stage of dementia is characterized by recurrent suspected infections. Research has
shown these episodes are widely mismanaged, leading to adverse patient and public health
outcomes. Antimicrobials are extensively prescribed in advanced dementia, most often in the
absence of clinical evidence to support a bacterial infection. Antimicrobial exposure is the
main risk factor for multidrug-resistant organisms (MDROs). Nursing home (NH) residents with
advanced dementia are three times more likely to be colonized with MDROs compared to other
residents. Moreover, as these patients are in the terminal phase of dementia, evidence
suggests they may not clinically benefit from antimicrobials. Comfort is the stated goal of
care for 90% of advanced dementia patients, and the risks and burdens associated with work-up
and treatment of suspected infections generally do not promote that goal, particularly when
hospitalization is involved. Taken together, there is a clear need to improve infection
management in advanced dementia both to provide better end-of-life care to these patients and
reduce the public health threat of MDROs.
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data
analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an
intervention to improve infection management for suspected UTIs and LRIs among residents with
advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of
randomization as the intervention must be delivered at the facility level to avoid
contamination and because this is how it would be employed in the real-world. Analyses will
be at the patient level.
shown these episodes are widely mismanaged, leading to adverse patient and public health
outcomes. Antimicrobials are extensively prescribed in advanced dementia, most often in the
absence of clinical evidence to support a bacterial infection. Antimicrobial exposure is the
main risk factor for multidrug-resistant organisms (MDROs). Nursing home (NH) residents with
advanced dementia are three times more likely to be colonized with MDROs compared to other
residents. Moreover, as these patients are in the terminal phase of dementia, evidence
suggests they may not clinically benefit from antimicrobials. Comfort is the stated goal of
care for 90% of advanced dementia patients, and the risks and burdens associated with work-up
and treatment of suspected infections generally do not promote that goal, particularly when
hospitalization is involved. Taken together, there is a clear need to improve infection
management in advanced dementia both to provide better end-of-life care to these patients and
reduce the public health threat of MDROs.
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data
analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an
intervention to improve infection management for suspected UTIs and LRIs among residents with
advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of
randomization as the intervention must be delivered at the facility level to avoid
contamination and because this is how it would be employed in the real-world. Analyses will
be at the patient level.
Inclusion Criteria:
Facility inclusion criteria
1. More than 60 beds
2. Within 60 miles of Boston
Resident inclusion eligibility criteria
- Age > or = to 60 years
- A diagnosis of dementia (any type)
- Global Deterioration Scale (GDS) score of 7
- NH length of stay >90 days
- An individual who can communicate in English has been formally or informally
designated as a health care proxy
- Not comatose GDS stage 7 features include: profound memory deficits (cannot recognize
family), total functional dependence, speech <= 5 words, incontinence, and
non-ambulatory. GDS 7 was chosen to define advanced dementia as it has been
successfully operationalized and validated in or prior studies, and experts agreed to
use this definition in research studies. A 90 day minimum length of stay was chosen to
exclude short-stay patients.
Provider inclusion criteria
- Direct care provider of advanced dementia residents (a nurse, nurse practitioner,
physician or physician assistant identified by a senior administrator as an individual
who cares for residents with advanced dementia)
- Can communicate in English (because intervention materials are all in English),
- Over 21 years of age.
Exclusion Criteria:
Residents with cognitive impairment due to causes other than dementia (e.g., head trauma
and in short-term, sub-acute SNFs) will be excluded.
Residents' whose proxies cannot communicate in English will be excluded from the study,
because the information directed to proxies are only in English.
Providers that do not provide direct care to residents with advanced dementia or who do not
speak English.
We found this trial at
1
site
Boston, Massachusetts 02131
Principal Investigator: Susan L Mitchell, MD, MPH
Phone: 617-281-3669
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