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

Primary Purpose

Dementia, Infection, Bacterial

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRAIN-AD
Sponsored by
Hebrew SeniorLife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring Nursing home, Palliative Care, Dementia, Infection, Antimicrobials

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Hebrew SeniorLife

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TRAIN-AD

CONTROL

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
August 7, 2017
Last Updated
July 19, 2021
Sponsor
Hebrew SeniorLife
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1. Study Identification

Unique Protocol Identification Number
NCT03244917
Brief Title
Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias
Acronym
TRAIN-AD
Official Title
Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (TRAIN-AD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew SeniorLife

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Infection, Bacterial
Keywords
Nursing home, Palliative Care, Dementia, Infection, Antimicrobials

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized Clinical Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
430 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRAIN-AD
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Facility randomized to the control arm will employ usual care for the management for suspected infections in advanced dementia,
Intervention Type
Behavioral
Intervention Name(s)
TRAIN-AD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Antimicrobial Use for LRI and UTIs
Description
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
Secondary Outcome Measure Information:
Title
Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs
Description
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
Title
Burdensome Interventions
Description
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
Title
Total Antimicrobial Use
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Facility inclusion criteria More than 60 beds 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Mitchell, MD. MPH
Organizational Affiliation
Hebrew SeniorLife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebrew SeniorLife
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34251396
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.
Results Reference
derived
PubMed Identifier
32258819
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. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100691.
Results Reference
derived
PubMed Identifier
31615540
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.
Results Reference
derived

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

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