N/A N=430 Randomized Quadruple-blind Health Services Research

Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias

Dementia · Infection, Bacterial

Bottom Line

View on ClinicalTrials.gov: NCT03244917 ↗

Enrolled (actual)

430

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Total Antimicrobial Use for LRI and UTIs — 0.55; 0.82 antimicrobial courses per person-year

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TRAIN-AD (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Hebrew SeniorLife
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Antimicrobial Use for LRI and UTIs	0.55; 0.82	—
SECONDARY Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs	0.37; 0.43	—
SECONDARY Burdensome Interventions	1.07; 1.69	—
SECONDARY Total Antimicrobial Use	0.82; 1.19	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03244917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.