Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0 (TRAIN-AD 2)

Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0 (TRAIN-AD 2.0)

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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Dementia; Alzheimer Disease
• Intervention / Treatment: Behavioral: TRAIN AD 2.0

Detailed Description

This 52-month study (8 months preparation; 34 months trial conduct; 10 months data analyses and manuscript preparation)is a parallel cluster ePCT of an intervention to improve infection management for suspected infections among residents with moderate to advanced dementia (N=600; N=300/arm) living in NHs (N=50; N=25/arm). Facilities are members of a provider managed care network, Iowa Health Care Quality Network ('Network'). The intervention will be similar to the original TRAIN-AD program, but adapted for moderate to advanced dementia and rolled out in the Network. At each intervention NH, the intervention will be implemented for 24-months. Control NHs will employ usual care. In all NHs, there will be a 2-month startup period, 12-month resident enrollment period, and 24-months data collection period (Figure 2). Eligible residents with dementia will be identified using the EHR and Minimum DataSet (MDS) and followed up to 12 months. Outcome data will be ascertained from the EHR. Randomization and program roll out will be at the facility level. Analyses at the resident level. Clinical outcomes compared between arms at 12 months will be: 1. Antimicrobial courses/person-year in residents with moderate to advanced dementia (primary outcome) and all residents with dementia (secondary outcome) (Aim 1); and 2. Number of burdensome procedures/person-year used to manage suspected infections among residents with moderate to advanced dementia and those at all stages of dementia including: hospital transfers, urine specimens, chest x-rays, and blood cultures (secondary outcomes) (Aim 2). A process evaluation of implementation will be conducted in the intervention arm based on the RE-AIM framework1 (Aim 3) using quantitative and qualitative data (stakeholder interviews).

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Mitchell, MD, MPH; Phone Number: 16172813669; Email: smitchell@hsl.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Recruiting
      • Hebrew SeniorLife
      • Contact: Susan Mitchell; Phone Number: 617-281-3669; Email: smitchell@hsl.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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. .
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.	Behavioral: 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. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial use in residents with moderate to advanced dementia	Number of antimicrobial courses/person-year among residents with moderate to advanced dementia.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial use in residents with dementia	Number of antimicrobial courses/person-year among residents with dementia at any stage.	12 months
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Hebrew SeniorLife
• Collaborators: Brown University
• Investigators: Principal Investigator: Susan Mitchell, MD, MPH, Hebrew SeniorLife

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Infections; Dementia
• Other Study ID Numbers: NIA R37AG032982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No