Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias
Completed · Not applicable
Conditions studied: Dementia, Infection, Bacterial
In brief
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.
Key facts
- Study ID
- NCT03244917
- Run by
- Hebrew SeniorLife
- People needed
- 430
- Starts
- 2017-10-15
- Expected to finish
- 2020-03-10
- Last updated by the study team
- 2021-08-10
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Facility inclusion criteria
- More than 60 beds
- 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.
You may not qualify if…
- 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.
Where it is running
- Hebrew SeniorLife — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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