Clinical trial NCT02909946: Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents
Official title: Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multi-antibiotic Resistance
Keywords: multidrug-resistant organisms
nursing home
post-acute care
long-term care
infection control
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Multidrug-resistant organisms (MDROs) are endemic in nursing homes (NHs) with prevalence rates surpassing those in hospitals. The aim of the study is to design and evaluate the effectiveness of a multi-component intervention to reduce new acquisition of MDROs in NH residents. The intervention will incorporate resident-level, environmental, and caregiver based strategies. Using a cluster-randomized study design, three NHs will be randomized to the intervention group and three to the control group. Control NHs will be allowed to continue standard infection prevention practices. Nursing homes will serve as the unit of allocation. Analyses will be performed both at the resident and the cluster level. The primary outcomes of the study are reduction in MDRO prevalence, and reduction in new MDRO acquisition .

Detailed description: The NH intervention will incorporate resident-level, environmental, and caregiver based strategies, including: a. Standard precautions and hand hygiene for care of all residents. Enhanced barrier precautions including hand hygiene, glove use, and gown use for healthcare workers (HCW) when providing activities of daily living (ADL) assistance for residents at highest-risk (caregiver intervention); b. Hand hygiene education to residents and families (resident-level intervention); c. Standardized bathing practices including using chlorhexidine-based cloths to reduce resident MDRO colonization (resident-level intervention); d. Standardized environmental protocol and education to reduce contamination on inanimate objects and surfaces (environmental intervention); e. Feedback monthly of facility-level microbial data and new MDRO acquisition rates to infection preventionists, front-line healthcare personnel, and facility leadership (facility intervention).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Residing in a participating NH facility
* Provided informed consent for participation

Exclusion Criteria:

* Receiving end-of-life care
* Non-English language speaking

Primary outcomes:
measure: Prevalence density of multidrug-resistant organisms (MDRO)
timeFrame: From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)
Secondary outcomes:
measure: Incidence of multidrug-resistant organisms (MDRO)
timeFrame: From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)
measure: Incidence of healthcare-associated infections
timeFrame: From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan and partner nursing homes
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lona Mody, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mody L, Gontjes KJ, Cassone M, Gibson KE, Lansing BJ, Mantey J, Kabeto M, Galecki A, Min L. Effectiveness of a Multicomponent Intervention to Reduce Multidrug-Resistant Organisms in Nursing Homes: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116555. doi: 10.1001/jamanetworkopen.2021.16555.