The Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer Disease and Other Dementias (TRAIN-AD): A Cluster Randomized Clinical Trial

Abstract

Importance: Antimicrobials are extensively prescribed to nursing home residents with advanced dementia, often without evidence of infection or consideration of the goals of care.

Objective: To test the effectiveness of a multicomponent intervention to improve the management of suspected urinary tract infections (UTIs) and lower respiratory infections (LRIs) for nursing home residents with advanced dementia.

Design, setting, and participants: A cluster randomized clinical trial of 28 Boston-area nursing homes (14 per arm) and 426 residents with advanced dementia (intervention arm, 199 residents; control arm, 227 residents) was conducted from August 1, 2017, to April 30, 2020.

Interventions: The intervention content integrated best practices from infectious diseases and palliative care for management of suspected UTIs and LRIs in residents with advanced dementia. Components targeting nursing home practitioners (physicians, physician assistants, nurse practitioners, and nurses) included an in-person seminar, an online course, management algorithms (posters, pocket cards), communication tips (pocket cards), and feedback reports on prescribing of antimicrobials. The residents' health care proxies received a booklet about infections in advanced dementia. Nursing homes in the control arm continued routine care.

Main outcomes and measures: The primary outcome was antimicrobial treatment courses for suspected UTIs or LRIs per person-year. Outcomes were measured for as many as 12 months. Secondary outcomes were antimicrobial courses for suspected UTIs and LRIs when minimal criteria for treatment were absent per person-year and burdensome procedures used to manage these episodes (bladder catherization, chest radiography, venous blood sampling, or hospital transfer) per person-year.

Results: The intervention arm had 199 residents (mean [SD] age, 87.7 [8.0] years; 163 [81.9%] women; 36 [18.1%] men), of which 163 (81.9%) were White and 27 (13.6%) were Black. The control arm had 227 residents (mean [SD] age, 85.3 [8.6] years; 190 [83.7%] women; 37 [16.3%] men), of which 200 (88.1%) were White and 22 (9.7%) were Black. There was a 33% (nonsignificant) reduction in antimicrobial treatment courses for suspected UTIs or LRIs per person-year in the intervention vs control arm (adjusted marginal rate difference, -0.27 [95% CI, -0.71 to 0.17]). This reduction was primarily attributable to reduced antimicrobial use for LRIs. The following secondary outcomes did not differ significantly between arms: antimicrobials initiated when minimal criteria were absent, bladder catheterizations, venous blood sampling, and hospital transfers. Chest radiography use was significantly lower in the intervention arm (adjusted marginal rate difference, -0.56 [95% CI, -1.10 to -0.03]). In-person or online training was completed by 88% of the targeted nursing home practitioners.

Conclusions and relevance: This cluster randomized clinical trial found that despite high adherence to the training, a multicomponent intervention promoting goal-directed care for suspected UTIs and LRIs did not significantly reduce antimicrobial use among nursing home residents with advanced dementia.

Trial registration: ClinicalTrials.gov Identifier: NCT03244917.

Figure 1.. CONSORT Diagram of Nursing Homes and Study Participants

UTI denotes urinary tract infection; LRI, lower respiratory infection. ^aFollow-up truncated by COVID-19 lockdown (n = 2). ^bOpted out or withdrawn by health care proxy (n = 1) and discharged from nursing home after baseline assessment (n = 1). ^cIncluded all residents with at least 1 follow-up assessment.

Figure 2.. Management Algorithms for Suspected Urinary Tract Infections (UTIs) and Lower Respiratory Infections (LRIs) in Nursing Home Residents With Advanced Dementia

CFU denotes colony-forming units; HR, heart rate; RR, respiratory rate; T, temperature; and UA, urine analysis. ^aAlgorithm applies to residents with dementia who are unable to meaningfully communicate information about symptoms typical of a UTI (eg, dysuria, suprapubic pain). The presence or absence of cloudy and/or odorous urine alone should not be used as an indication to send a urine specimen for evaluation or to start an antimicrobial. ^bWithout an indwelling urinary catheter, mental status change alone is not an adequate symptom to support a diagnosis of a UTI. ^cAntimicrobials may be initiated empirically while urine specimen results are pending. ^dPositive urinalysis ≥10 000 white blood cells/L or dipstick results positive for white blood cells, leukocyte esterase, or nitrites. ^ePositive urine culture: no indwelling urinary catheter ≥10⁵ CFU/mL of ≥1 bacterial organism; with indwelling urinary catheter ≥ 10³ CFU/mL. ^fA complete blood cell count with differential and chest radiography may not be required for empiric antimicrobial treatment.