Reducing antibiotic use in nursing home residents with dementia
Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0 (TRAIN-AD 2.0)
This study is testing a new approach to help nursing home residents with dementia manage infections better while using fewer antibiotics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 60 Years to 106 Years |
| Sex | All |
| Sponsor | Hebrew SeniorLife Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05950607 on ClinicalTrials.gov |
What this trial studies
This pragmatic cluster randomized clinical trial aims to improve the management of suspected infections in nursing home residents with dementia. It will compare a multicomponent intervention designed to optimize infection management against usual care in a population of 600 residents across 50 nursing homes. The study will assess the impact of the intervention on antibiotic use and the number of burdensome procedures over a 24-month period. Data will be collected from electronic health records and analyzed to determine the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are nursing home residents aged over 60 with a diagnosis of dementia and a Cognitive Functional Scale score greater than 1.
Not a fit: Patients under 60 years of age or those without a diagnosis of dementia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced antibiotic use and less invasive procedures for nursing home residents with dementia, improving their quality of care.
How similar studies have performed: Other studies have shown success with similar interventions aimed at optimizing infection management in elderly populations, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Hebrew SeniorLife — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Susan Mitchell, MD, MPH — Hebrew SeniorLife
- Study coordinator: Susan Mitchell, MD, MPH
- Email: smitchell@hsl.harvard.edu
- Phone: 16172813669
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.