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

NCT ID: NCT03244917

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-15
• Study Completion Date: 2020-03-10

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.

Conditions

Dementia; Infection, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

TRAIN-AD

Intervention Type: BEHAVIORAL

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.

CONTROL

Facility randomized to the control arm will employ usual care for the management for suspected infections in advanced dementia,

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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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• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebrew SeniorLife

OTHER

Sponsor Role: lead

Responsible Party

Susan Mitchell, MD

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan L Mitchell, MD. MPH

Role: PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife

Locations

Hebrew SeniorLife

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34251396 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32258819 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31615540 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TRAIN-AD

Identifier Type: -

Identifier Source: org_study_id