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Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

Not Applicable
Completed
Conditions
Multi-antibiotic Resistance
Interventions
Behavioral: Multi-modal Infection Control Program
Registration Number
NCT02909946
Lead Sponsor
University of Michigan
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
246
Inclusion Criteria
  • Age ≥ 18 years old
  • Residing in a participating NH facility
  • Provided informed consent for participation
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Exclusion Criteria
  • Receiving end-of-life care
  • Non-English language speaking
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention ArmMulti-modal Infection Control ProgramNHs randomized to the Intervention Arm will implement a new multi-modal infection control program.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

University of Michigan and partner nursing homes

🇺🇸

Ann Arbor, Michigan, United States

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