Clinical trial NCT03244917: Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias
Official title: Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (TRAIN-AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Infection, Bacterial
Keywords: Nursing home
Palliative Care
Dementia
Infection
Antimicrobials
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 430
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Clinical Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Facility inclusion criteria

1. More than 60 beds
2. Within 60 miles of Boston

Resident inclusion eligibility criteria

* Age \> or = to 60 years
* A diagnosis of dementia (any type)
* Global Deterioration Scale (GDS) score of 7
* NH length of stay \>90 days
* An individual who can communicate in English has been formally or informally designated as a health care proxy
* Not comatose GDS stage 7 features include: profound memory deficits (cannot recognize family), total functional dependence, speech \<= 5 words, incontinence, and non-ambulatory. GDS 7 was chosen to define advanced dementia as it has been successfully operationalized and validated in or prior studies, and experts agreed to use this definition in research studies. A 90 day minimum length of stay was chosen to exclude short-stay patients.

Provider inclusion criteria

* Direct care provider of advanced dementia residents (a nurse, nurse practitioner, physician or physician assistant identified by a senior administrator as an individual who cares for residents with advanced dementia)
* Can communicate in English (because intervention materials are all in English),
* Over 21 years of age.

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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Primary outcomes:
measure: Total Antimicrobial Use for LRI and UTIs
timeFrame: 12 months
Secondary outcomes:
measure: Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs
timeFrame: 12 months
measure: Burdensome Interventions
timeFrame: 12 months
measure: Total Antimicrobial Use
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Hebrew SeniorLife
state: Massachusetts
Study officials:
affiliation: Hebrew SeniorLife
name: Susan L Mitchell, MD. MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell SL, D'Agata EMC, Hanson LC, Loizeau AJ, Habtemariam DA, Tsai T, Anderson RA, Shaffer ML. The Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer Disease and Other Dementias (TRAIN-AD): A Cluster Randomized Clinical Trial. JAMA Intern Med. 2021 Sep 1;181(9):1174-1182. doi: 10.1001/jamainternmed.2021.3098.
citation: Shaffer ML, D'Agata EMC, Habtemariam D, Mitchell SL. Covariate-constrained randomization for cluster randomized trials in the long-term care setting: Application to the TRAIN-AD trial. Contemp Clin Trials Commun. 2020 Mar 17;18:100558. doi: 10.1016/j.conctc.2020.100558. eCollection 2020 Jun.
citation: Loizeau AJ, D'Agata EMC, Shaffer ML, Hanson LC, Anderson RA, Tsai T, Habtemariam DA, Bergman EH, Carroll RP, Cohen SM, Scott EME, Stevens E, Whyman JD, Bennert EH, Mitchell SL. The trial to reduce antimicrobial use in nursing home residents with Alzheimer's disease and other dementias: study protocol for a cluster randomized controlled trial. Trials. 2019 Oct 15;20(1):594. doi: 10.1186/s13063-019-3675-y.