Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias

Dementia Clinical Trial

— TRAIN-AD  

Official title:

Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (TRAIN-AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244917
• Other study ID #: TRAIN-AD
• Status: Completed
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: March 10, 2020

Study information

• Verified date: July 2021
• Source: Hebrew SeniorLife
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Alzheimer Disease
• Bacterial Infections
• Dementia
• Infection, Bacterial

Intervention

Behavioral:
• TRAIN-AD
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.

Locations

Country	Name	City	State
United States	Hebrew SeniorLife	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew SeniorLife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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.	12 months
Secondary	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	12 months
Secondary	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	12 months