Reducing Antibiotic Use for Dementia
(TRAIN-AD 2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Hebrew SeniorLife
Disqualifiers: Age < 60, No dementia, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment TRAIN AD 2.0 for reducing antibiotic use in dementia patients?
The TRAIN-AD intervention, which is similar to TRAIN AD 2.0, was a program aimed at improving infection management in nursing home residents with advanced dementia, suggesting that structured programs can help reduce unnecessary antibiotic use in this population.
12345Is the treatment in the clinical trial generally safe for humans?
The research highlights that people with dementia are at risk of adverse drug reactions (ADRs), but it does not provide specific safety data for the treatment in the clinical trial.
678910How is the TRAIN AD 2.0 treatment different from other treatments for reducing antibiotic use in dementia patients?
TRAIN AD 2.0 is unique because it is a multicomponent program designed to improve infection management specifically for nursing home residents with advanced dementia, focusing on reducing unnecessary antibiotic use by considering the goals of care and evidence of infection.
34111213Eligibility Criteria
This trial is for nursing home residents over 60 years old with a diagnosis of any type of dementia, who have lived in the facility for more than 90 days. They must have moderate to severe cognitive impairment. It's not suitable for those without or with only mild cognitive issues.Inclusion Criteria
NH length of stay >90 days
Cognitive Functional Scale (CFS) > 1
I have been diagnosed with a form of dementia.
+1 more
Exclusion Criteria
Does not have diagnosis of dementia
Does not meet CFS >1 score
Living in nursing home for less than 90 days
+1 more
Trial Timeline
Preparation
Preparation phase for setting up the trial, including randomization and program roll out at the facility level
8 months
Startup
Initial startup period for the trial in all nursing homes
2 months
Resident Enrollment
Enrollment of eligible residents with dementia using the EHR and Minimum DataSet (MDS)
12 months
Intervention Implementation
Implementation of the multicomponent intervention in the experimental arm nursing homes
24 months
Data Collection
Data collection period for all nursing homes
24 months
Follow-up
Participants are monitored for safety and effectiveness after the intervention
12 months
Data Analysis and Manuscript Preparation
Analysis of collected data and preparation of manuscripts
10 months
Participant Groups
The study tests TRAIN AD 2.0, an intervention designed to optimize infection management among dementia patients, aiming to reduce antibiotic use and avoid unnecessary treatments compared to standard care practices.
2Treatment groups
Experimental Treatment
Active Control
Group I: TRAIN AD 2.0Experimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
Nursing homes randomized to the conrol arm will employ usual care to manage nursing home residents with dementia with suspected infections.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hebrew SeniorLifeBoston, MA
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Who Is Running the Clinical Trial?
Hebrew SeniorLifeLead Sponsor
Brown UniversityCollaborator
References
Can clinician champions reduce potentially inappropriate medications in people living with dementia? Study protocol for a cluster randomized trial. [2022]For people living with dementia (PLWD) the overuse of potentially inappropriate medications (PIMs) remains a persistent problem. De-prescribing trials in the elderly have mixed results. Clinician champions may be uniquely suited to lead efforts to address this challenge. Here we describe the study protocol for a 24-month embedded pragmatic cluster-randomized clinical trial within two accountable care organizations (ACOs) of such a clinician champion intervention. The specific aims are to (1) assess the effectiveness of a clinician champion on de-implementing PIMs in PLWD, (2) determine if the intervention is associated with a reduction in emergency department (ED) visits and hospitalizations attributed to a fall, and (3) examine five implementation outcomes: appropriateness, feasibility, fidelity, penetration, and equity.
Cholinesterase inhibitor and memantine use in newly admitted nursing home residents with dementia. [2021]To quantify the use of cholinesterase inhibitors (ChEIs) and memantine in nursing home (NH) residents with dementia upon NH admission and 3 months later and to examine factors associated with reduction in therapy.
Provider adherence to training components from the Trial to Reduce Antimicrobial use In Nursing home residents with Alzheimer's disease and other Dementias (TRAIN-AD) intervention. [2022]Label="Background" NlmCategory="UNASSIGNED">The Trial to Reduce Antimicrobial use In Nursing home residents with Alzheimer's disease and other Dementias (TRAIN-AD) was a cluster randomized clinical trial evaluating a multicomponent program to improve infection management among residents with advanced dementia. This report examines facility and provider characteristics associated with greater adherence to training components of the TRAIN-AD intervention.
Factors Associated With Antimicrobial Use in Nursing Home Residents With Advanced Dementia. [2022]Widespread antimicrobial misuse among nursing home (NH) residents with advanced dementia raises concerns regarding the emergence of multidrug-resistant organisms and avoidable treatment burden in this vulnerable population. The objective of this report was to identify facility and resident level characteristics associated with receipt of antimicrobials in this population.
Attributable Cost of Dementia: Demonstrating Pitfalls of Ignoring Multiple Health Care System Utilization. [2019]To determine dementia prevalence and costs attributable to dementia using Veterans Health Administration (VHA) data with and without Medicare data.
Adverse drug reactions in patients with Alzheimer's disease and related dementia in France: a national multicentre cross-sectional study. [2013]To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer's disease (AD) or other dementia in France.
Identifying potentially inappropriate prescribing in older people with dementia: a systematic review. [2022]Older people with dementia are at risk of adverse events associated with potentially inappropriate prescribing.
Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review. [2021]This systematic review aimed to quantify the prevalence of adverse drug events (ADEs) and adverse drug reactions (ADRs) in older inpatients with dementia.
Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial. [2018]People with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines' monitoring.
Adverse clinical outcomes associated with drug-related hospitalizations in people with dementia. [2023]This study aimed to determine the clinical impact associated with adverse drug reactions (ADRs) in patients with dementia.
Antimicrobial resistance in Escherichia coli and Klebsiella pneumoniae urine isolates from a national sample of home-based primary care patients with dementia. [2023]Annual prevalences of antimicrobial resistance among urine isolates (3,913 Escherichia coli isolates and 1,736 Klebsiella pneumoniae isolates) from home-based primary care patients with dementia were high between 2014 and 2018 (ciprofloxacin, 18%-23% and 5%-7%, respectively; multidrug resistance, 9%-11% and 5%-6%, respectively). Multidrug resistance varied by region. Additional studies of antimicrobial resistance in home-care settings are needed.
Occurrence and treatment of suspected pneumonia in long-term care residents dying with advanced dementia. [2008]To describe the occurrence and management of suspected pneumonia in end-stage dementia and to identify factors associated with aggressiveness of antibiotic treatment.
The Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer Disease and Other Dementias (TRAIN-AD): A Cluster Randomized Clinical Trial. [2022]Antimicrobials are extensively prescribed to nursing home residents with advanced dementia, often without evidence of infection or consideration of the goals of care.