Recruiting

Antimicrobial Reduction

Sponsor:

Hebrew SeniorLife

Code:

NCT05950607

Conditions

Dementia

Alzheimer Disease

Infections

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

TRAIN AD 2.0

Study Details

Brief summary:

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.

Conditions

Dementia

Alzheimer Disease

Infections

Study ID

NCT05950607

Start date

Nov 13, 2023

Status verified date

Jan, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age > 60
2. A diagnosis of dementia (any type)
3. Cognitive Functional Scale (CFS) > 1
4. NH length of stay >90 days

The CFS score categorizes cognitive impairment status based on data in the electronic health record into: 1. None, 2. Mild, 3. Moderate, and 4. Severe (advanced). For the primary outcome, the analysis will be restricted to residents with a CFS score of 3 or 4.

Exclusion Criteria:

1. Less than 60 years of age
2. Living in nursing home for less than 90 days
3. Does not have diagnosis of dementia
4. Does not meet CFS >1 score

Study Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: TRAIN AD 2.0

Nursing homes randomized to the experimental arm will emply a multicomponent intervention among their providers designed to improve the management of suspected infections in residents with dementia. The components include: a.Orientation sessions for providers, b.On-line case based course for providers, c.Infection management algorithms for providers, d. Guidelines for providers to communicate with proxies, and e. Education booklet about infections in dementia for providers.

active comparator: Usual Care

Nursing homes randomized to the conrol arm will employ usual care to manage nursing home residents with dementia with suspected infections.

Interventions

TRAIN AD 2.0

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. .

Primary outcome measure

  • Antimicrobial use in residents with moderate to advanced dementia [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Susan Mitchell, MD, MPH

16172813669smitchell@hsl.harvard.edu

Locations

Hebrew SeniorLife

Recruiting

Boston, Massachusetts, United States, 02131

Contacts

Susan Mitchell

617-281-3669smitchell@hsl.harvard.edu

More Information

Sponsor

Hebrew SeniorLife

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hebrew SeniorLife on 2026-01-06.