Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-106
SponsorHebrew SeniorLife

About this trial

The goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 60

A diagnosis of dementia (any type)

Cognitive Functional Scale (CFS) > 1

NH length of stay >90 days

Disqualifiers

Less than 60 years of age

Living in nursing home for less than 90 days

Does not have diagnosis of dementia

Does not meet CFS >1 score

Trial design

Design model

Parallel

Treatments tested in this trial

  • TRAIN AD 2.0

    Behavioral

    The study intervention is a multi-component training program targeting direct care providers and healthcare proxies for NH residents with moderate to advanced dementia intended to improve the management of urinary tract infections (UTIs) and lower respiratory tract infections (LRIs). The components include: A. Provider Orientation: At NH start-up and q2 months providers will be offered orientations sessions involving two 15-minute presentations, one focused on the background and rationale for the program and one focused on describing the program components. B. A case-based on-line course, "Infection Management in Moderate to Advanced Dementia," C. Posters and pocket cards for providers displaying algorithms guiding appropriate antimicrobial initiation for suspected UTIs and LRIs that integrate patient preferences, and D. Proxies of ALL residents in the facility will be sent a booklet related to infection management for persons with moderate to advanced dementia. .

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: TRAIN AD 2.0Experimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Antimicrobial use in residents with moderate to advanced dementia

Number of antimicrobial courses/person-year among residents with moderate to advanced dementia.

Time frame
12 months

Secondary outcomes

1

Antimicrobial use in residents with dementia

Number of antimicrobial courses/person-year among residents with dementia at any stage.

Time frame
12 months
2

Burdensome interventions in residents with moderate to advanced dementia

Number of burdensome interventions (hospital transfers, bladder catheterization, chest x-ray, blood cultures) used to evaluate suspected infections/person-year among residents withmoderate to advanced dementia.

Time frame
12 months
3

Burdensome interventions in residents with dementia

Number of burdensome interventions (hospital transfers, bladder catheterization, chest x-ray, blood cultures) used to evaluate suspected infections/person-year among residents with dementia.

Time frame
12 months

Other outcomes

Sponsors and contacts

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Hebrew SeniorLife

Lead sponsor

Brown University

Collaborator