Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (TRAIN-AD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03244917|
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia Infection, Bacterial||Behavioral: TRAIN-AD||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|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|
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.
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,
- 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
- 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.
- 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
- 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
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
|Contact: Susan L Mitchell, MD, MPHfirstname.lastname@example.org|
|Contact: Elaine Bergman, MA||617-971-5335||ElaineBergman@hsl.harvard.edu|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02131|
|Contact: Susan L Mitchell, MD, MPH 617-281-3669 email@example.com|
|Principal Investigator: Susan L Mitchell, MD, MPH|
|Principal Investigator:||Susan L Mitchell, MD. MPH||Hebrew SeniorLife|