An interventional study of TRAIN-AD in Dementia and Infection, Bacterial, sponsored by Hebrew SeniorLife. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-08-10.
Sponsored by Hebrew SeniorLife · Not applicable, Interventional, and Health services research
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world. Analyses will be at the patient level.
The final stage of dementia is characterized by recurrent suspected infections. Research has shown these episodes are widely mismanaged, leading to adverse patient and public health outcomes. Antimicrobials are extensively prescribed in advanced dementia, most often in the absence of clinical evidence to support a bacterial infection. Antimicrobial exposure is the main risk factor for multidrug-resistant organisms (MDROs). Nursing home (NH) residents with advanced dementia are three times more likely to be colonized with MDROs compared to other residents. Moreover, as these patients are in the terminal phase of dementia, evidence suggests they may not clinically benefit from antimicrobials. Comfort is the stated goal of care for 90% of advanced dementia patients, and the risks and burdens associated with work-up and treatment of suspected infections generally do not promote that goal, particularly when hospitalization is involved. Taken together, there is a clear need to improve infection management in advanced dementia both to provide better end-of-life care to these patients and reduce the public health threat of MDROs.
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia (N=410; N=205/arm) living in NHs (N=28; N=14/arm). The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world. Analyses will be at the patient level.
658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.
This study's enrollment of 430 is above the median of 84 across 405 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Hebrew SeniorLife is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Facility inclusion criteria
Resident inclusion eligibility criteria
Provider inclusion criteria
Exclusion Criteria:
Residents with cognitive impairment due to causes other than dementia (e.g., head trauma and in short-term, sub-acute SNFs) will be excluded.
Residents' whose proxies cannot communicate in English will be excluded from the study, because the information directed to proxies are only in English.
Providers that do not provide direct care to residents with advanced dementia or who do not speak English.
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The study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education.
Behavioral: TRAIN-AD
Facility randomized to the control arm will employ usual care for the management for suspected infections in advanced dementia,
The study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education. Intervention components aimed at the provider include: Professionally led infection management training seminars, online infection management course, and infection management guidance algorithms. Additionally participating prescribing providers will be sent bimonthly infection management feedback reports. Proxy Education is completed by providing an infection management in Advanced Dementia booklet to proxies of patients with AD upon resident enrollment in study.
Total Antimicrobial Use for LRI and UTIs
The investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
Time frame: 12 months
Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs
The investigators will compare the number of antimicrobial courses prescribed for suspected UTIs and LRIs when minimal criteria for treatment initiation are absent based on consensus guidelines/person-year (secondary outcome) in the intervention vs. control arm over 12 months.
Time frame: 12 months
Burdensome Interventions
The investigators will compare the number of burdensome procedures used to evaluate suspected LRIs and UTIs (hospital transfer, bladder catheterization, chest x-ray, blood draws)/person-year between the intervention versus control arm
Time frame: 12 months
Total Antimicrobial Use
The investigators will compare the total number of antimicrobial courses prescribed for any reason /person-year over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
Time frame: 12 months
| Milestone | TRAIN-AD | Control |
|---|---|---|
| Started | 201 | 229 |
| Completed | 199 | 227 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 2 | 2 |
The investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
| antimicrobial courses per person-year | TRAIN-AD | Control |
|---|---|---|
| Total Antimicrobial Use for LRI and UTIs | 0.55 (0.25 to 0.84) | 0.82 (0.49 to 1.14) |
The investigators will compare the number of antimicrobial courses prescribed for suspected UTIs and LRIs when minimal criteria for treatment initiation are absent based on consensus guidelines/person-year (secondary outcome) in the intervention vs. control arm over 12 months.
| antimicrobial courses per person-year | TRAIN-AD | Control |
|---|---|---|
| Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs | 0.37 (0.15 to 0.60) | 0.43 (0.23 to 0.62) |
The investigators will compare the number of burdensome procedures used to evaluate suspected LRIs and UTIs (hospital transfer, bladder catheterization, chest x-ray, blood draws)/person-year between the intervention versus control arm
| interventions per person-year | TRAIN-AD | Control |
|---|---|---|
| Burdensome Interventions | 1.07 (0.54 to 1.60) | 1.69 (0.87 to 2.51) |
The investigators will compare the total number of antimicrobial courses prescribed for any reason /person-year over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
| antimicrobial courses per person-year | TRAIN-AD | Control |
|---|---|---|
| Total Antimicrobial Use | 0.82 (0.52 to 1.13) | 1.19 (0.83 to 1.56) |
Collected over Each residents was followed for up to one year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TRAIN-AD | 82/199 (41.2%) | 0/199 (0%) | 0/199 (0%) |
| Control | 102/227 (44.9%) | 0/227 (0%) | 0/227 (0%) |
| Age, Continuous(years) | TRAIN-AD | Control | Total |
|---|---|---|---|
| Mean | 87.7 ± 8.0 | 85.3 ± 8.6 | 86.3 ± 8.4 |
| Sex: Female, Male(Participants) | TRAIN-AD | Control | Total |
|---|---|---|---|
| Female | 163 | 190 | 353 |
| Male | 36 | 37 | 73 |
| Race (NIH/OMB)(Participants) | TRAIN-AD | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 27 | 22 | 49 |
| White | 166 | 200 | 366 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 3 | 5 |
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