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

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ClinicalTrials.gov Identifier: NCT03244917
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Susan Mitchell, MD, Hebrew Rehabilitation Center, Boston

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.

Condition or disease Intervention/treatment Phase
Dementia Infection, Bacterial Behavioral: TRAIN-AD Not Applicable

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=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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomized Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The research assistants collecting outcome data through chart reviews and follow-up proxy interviews will be blinded to nursing home randomization. The Principal Investigator, data programmers, and statistician will be blinded to treatment assignment
Primary Purpose: Health Services Research
Official Title: Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (TRAIN-AD)
Actual Study Start Date : October 15, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: CONTROL
Facility randomized to the control arm will employ usual care for the management for suspected infections in advanced dementia,



Primary Outcome Measures :
  1. Total antimicrobial use [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. Antimicrobial use when minimal criteria are absent [ Time Frame: 12 months ]
    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.

  2. Burdensome interventions [ Time Frame: 12 months ]
    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

  3. Advance care planning [ Time Frame: 12 months ]
    The investigators will compare advance care planning about infection management (e.g., documented discussions between proxies and providers, advance directives to withhold antimicrobials) between the intervention and control arms



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244917


Contacts
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Contact: Susan L Mitchell, MD, MPH 617-281-3669 smitchell@hsl.harvard.edu
Contact: Elaine Bergman, MA 617-971-5335 ElaineBergman@hsl.harvard.edu

Locations
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United States, Massachusetts
Hebrew SeniorLife Recruiting
Boston, Massachusetts, United States, 02131
Contact: Susan L Mitchell, MD, MPH    617-281-3669    smitchell@hsl.harvard.edu   
Principal Investigator: Susan L Mitchell, MD, MPH         
Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
Investigators
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Principal Investigator: Susan L Mitchell, MD. MPH Hebrew SeniorLife

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Responsible Party: Susan Mitchell, MD, Senior Scientist, Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier: NCT03244917     History of Changes
Other Study ID Numbers: TRAIN-AD
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susan Mitchell, MD, Hebrew Rehabilitation Center, Boston:
Nursing home
Palliative Care
Dementia
Infection
Antimicrobials

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Bacterial Infections
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Anti-Infective Agents
Anti-Bacterial Agents