Journal Article

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

Whyman, Jeremy D., Habtemariam, Daniel A., Mitchell, Susan L., Carroll, Ruth P., Stevens, Erin, Anderson, Ruth A., Bergman, Elaine H., Shaffer, Michele L., Bennert, Elizabeth H., D’Agata, Erika M. C., Tsai, Timothy, Loizeau, Andrea J., Hanson, Laura C., Scott, Erin M. E., Cohen, Simon M.

2019

Overview

Background Infections are common in nursing home (NH) residents with advanced dementia but are often managed inappropriately. Antimicrobials are extensively prescribed, but frequently with insufficient evidence to support a bacterial infection, promoting the emergence of multidrug-resistant organisms. Moreover, the benefits of antimicrobials remain unclear in these seriously ill residents for whom comfort is often the goal of care. Prior NH infection management interventions evaluated in randomized clinical trials (RCTs) did not consider patient preferences and lack evidence to support their effectiveness in ‘real-world’ practice. Methods This report presents the rationale and methodology of TRAIN-AD (Trial to reduce antimicrobial use in nursing home residents with Alzheimer’s disease and other dementias), a parallel group, cluster RCT evaluating a multicomponent intervention to improve infection management for suspected urinary tract infections (UTIs) and lower respiratory tract infections (LRIs) among NH residents with advanced dementia. TRAIN-AD is being conducted in 28 facilities in the Boston, USA, area randomized in waves using minimization to achieve a balance on key characteristics ( N  = 14 facilities/arm). The involvement of the facilities includes a 3-month start-up period and a 24-month implementation/data collection phase. Residents are enrolled during the first 12 months of the 24-month implementation period and followed for up to 12 months. Individual consent is waived, thus almost all eligible residents are enrolled (target sample size, N  = 410). The intervention integrates infectious disease and palliative care principles and includes provider training delivered through multiple modalities (in-person seminar, online course, management algorithms, and prescribing feedback) and an information booklet for families. Control facilities employ usual care. The primary outcome, abstracted from the residents’ charts, is the number of antimicrobial courses prescribed for UTIs and LRIs per person-year alive. Discussion TRAIN-AD is the first cluster RCT testing a multicomponent intervention to improve infection management in NH residents with advanced dementia. Its findings will provide an evidence base to support the benefit of a program addressing the critical clinical and public health problem of antimicrobial misuse in these seriously ill residents. Moreover, its hybrid efficacy-effectiveness design will inform the future conduct of cluster RCTs evaluating nonpharmacological interventions in the complex NH setting in a way that is both internally valid and adaptable to the ‘real-world’. Trial registration ClinicalTrials.gov, NCT03244917 . Registered on 10 August 2017.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Advertising executives / Aged / Aged, 80 and over / Algorithms / Alzheimer Disease - therapy / Alzheimer's disease / Americans / Analysis / Anti-Infective Agents - adverse effects / Anti-Infective Agents - therapeutic use / Antimicrobial agents / Antimicrobial Stewardship / Antimicrobials / Bacterial infections / Biomedicine / Boston / Care and treatment / Clinical trials / Cognitive ability / Communicable diseases / Data collection / Decision making / Dementia / Enrollments / Female / Handbooks / Health aspects / Health Sciences / Homes for the Aged / Humans / Infection / Infections / Intervention / Male / Medical research / Medicare / Medicine / Medicine & Public Health / Microbial drug resistance / Middle Aged / Multicenter Studies as Topic / Nursing home patients / Nursing Homes / Palliative care / Prescription writing / Public health / Randomized Controlled Trials as Topic / Respiratory Tract Infections - diagnosis / Respiratory Tract Infections - drug therapy / Respiratory Tract Infections - microbiology / Retirement benefits / Review boards / Services / Statistics for Life Sciences / Study Protocol / Time Factors / Treatment Outcome / Unnecessary Procedures / Urinary tract infections / Urinary Tract Infections - diagnosis / Urinary Tract Infections - drug therapy / Urinary Tract Infections - microbiology