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

• Sponsor: Hebrew SeniorLife (Other)
• Overall Status: Completed
• CT.gov ID: NCT03244917
• Collaborator: (none)
• Enrollment: 430
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.8
• Patients Per Site Per Month: 14.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Infection, Bacterial	Behavioral: TRAIN-AD	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 430 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Cluster Randomized Clinical TrialCluster 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: Oct 15, 2017
• Actual Primary Completion Date: Mar 10, 2020
• Actual Study Completion Date: Mar 10, 2020

Arms and Interventions

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,

Outcome Measures

Primary Outcome Measures

1. Total Antimicrobial Use for LRI and UTIs [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 for LRI and UTIs [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 [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. Total Antimicrobial Use [12 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hebrew SeniorLife	Boston	Massachusetts	United States	02131

Sponsors and Collaborators

• Hebrew SeniorLife

Investigators

• Principal Investigator: Susan L Mitchell, MD. MPH, Hebrew SeniorLife

Study Documents (Full-Text)

• Study Protocol - Jun 30, 2017
• Statistical Analysis Plan - Apr 15, 2020

More Information

Publications

None provided.

• Responsible Party: Susan Mitchell, MD, Senior Scientist, Hebrew SeniorLife
• ClinicalTrials.gov Identifier: NCT03244917
• Other Study ID Numbers: TRAIN-AD
• First Posted: Aug 10, 2017
• Last Update Posted: Aug 10, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Susan Mitchell, MD, Senior Scientist, Hebrew SeniorLife: Nursing home; Palliative Care; Dementia; Infection; Antimicrobials
• Additional relevant MeSH terms: Bacterial Infections; Alzheimer Disease; Dementia

Study Results

Participant Flow

Arm/Group Title	TRAIN-AD	Control
Arm/Group Description	Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections	Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
Period Title: Overall Study
STARTED	201	229
COMPLETED	199	227
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	TRAIN-AD	Control	Total
Arm/Group Description	Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections	Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections	Total of all reporting groups
Overall Participants	199	227	426
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	87.7 (8.0)	85.3 (8.6)	86.3 (8.4)
Sex: Female, Male (Count of Participants)
Female	163 81.9%	190 83.7%	353 82.9%
Male	36 18.1%	37 16.3%	73 17.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 2%	2 0.9%	6 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	27 13.6%	22 9.7%	49 11.5%
White	166 83.4%	200 88.1%	366 85.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 1%	3 1.3%	5 1.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TRAIN-AD	Control
Arm/Group Description	Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections	Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
Measure Participants	199	227
Number (95% Confidence Interval) [antimicrobial courses per person-year]	0.55	0.82

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TRAIN-AD	Control
Arm/Group Description	Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections	Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
Measure Participants	199	227
Number (95% Confidence Interval) [antimicrobial courses per person-year]	0.37	0.43

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TRAIN-AD	Control
Arm/Group Description	Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections	Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
Measure Participants	199	227
Number (95% Confidence Interval) [interventions per person-year]	1.07	1.69

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TRAIN-AD	Control
Arm/Group Description	Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections	Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
Measure Participants	199	227
Number (95% Confidence Interval) [antimicrobial courses per person-year]	0.82	1.19

Adverse Events

Time Frame	Each residents was followed for up to one year
Adverse Event Reporting Description	There were no pre-specified adverse events in this minimal risk study
Arm/Group Title	TRAIN-AD		Control
Arm/Group Description	Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections		Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
All Cause Mortality
	TRAIN-AD		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	82/199 (41.2%)		102/227 (44.9%)
Serious Adverse Events
	TRAIN-AD		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/199 (0%)		0/227 (0%)
Other (Not Including Serious) Adverse Events
	TRAIN-AD		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/199 (0%)		0/227 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.