Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TRAIN AD 2.0.
- Who it may be relevant to
- Registry conditions: Dementia, Alzheimer Disease, Infections. Basic parameters: 60 years — 106 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0 (TRAIN-AD 2.0)
Overview
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.
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).
Interventions
- 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 th
Primary outcome measures
- Antimicrobial use in residents with moderate to advanced dementia [Time frame: 12 months]
Secondary outcome measures (3)
- Antimicrobial use in residents with dementia [Time frame: 12 months]
- Burdensome interventions in residents with moderate to advanced dementia [Time frame: 12 months]
- Burdensome interventions in residents with dementia [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Age > 60
- A diagnosis of dementia (any type)
- Cognitive Functional Scale (CFS) > 1
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Hebrew SeniorLife — Boston
Identifiers
NCT: NCT05950607 · NIA R37AG032982