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Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02909946
Enrollment
246
Registered
2016-09-21
Start date
2016-09-15
Completion date
2018-08-29
Last updated
2018-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multi-antibiotic Resistance

Keywords

multidrug-resistant organisms, nursing home, post-acute care, long-term care, infection control

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).

Interventions

BEHAVIORALMulti-modal Infection Control Program

1. Standard precautions and hand hygiene for care of all residents. Enhanced barrier precautions including hand hygiene, glove use, and gown use for HCW when providing ADL assistance for residents at highest-risk (caregiver intervention). 2. Hand hygiene education to residents and families (resident-level intervention). 3. Standardized bathing practices including using chlorhexidine-based cloths to reduce resident MDRO colonization (resident-level intervention). 4. Standardized environmental protocol and education to reduce contamination on inanimate objects and surfaces (environmental intervention). 5. Feedback monthly of facility-level microbial data and new MDRO acquisition rates to infection control practitioners, HCWs, and facility leadership (facility intervention).

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence density of multidrug-resistant organisms (MDRO)From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)Total number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents over the duration of the study period

Secondary

MeasureTime frameDescription
Incidence of multidrug-resistant organisms (MDRO)From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)Total number of MDROs newly acquired (resident not colonized at baseline) isolated across all MDROs for all enrolled residents over the duration of the study period
Incidence of healthcare-associated infectionsFrom enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)Total number of new infections acquired at the nursing home for all enrolled residents over the duration of the study period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026