Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

Study Overview
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Brief Summary
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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
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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).

Official Title
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Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

Conditions
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Multi-antibiotic Resistance

Intervention / Treatment
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* Behavioral: Multi-modal Infection Control Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Arm<br>NHs randomized to the Intervention Arm will implement a new multi-modal infection control program. | Behavioral: Multi-modal Infection Control Program<br>* 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). Hand hygiene education to residents and families (resident-level intervention). Standardized bathing practices including using chlorhexidine-based cloths to reduce resident MDRO colonization (resident-level intervention). Standardized environmental protocol and education to reduce contamination on inanimate objects and surfaces (environmental intervention). Feedback monthly of facility-level microbial data and new MDRO acquisition rates to infection control practitioners, HCWs, and facility leadership (facility intervention).<br>|
| No Intervention: Control Arm<br>NHs randomized to the Control Arm will continue their current standard infection control practices. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of multidrug-resistant organisms (MDRO) | 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 | From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death) | 
| Incidence of healthcare-associated infections | Total number of new infections acquired at the nursing home for all enrolled residents over the duration of the study period | From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multidrug-resistant organisms, nursing home, post-acute care, long-term care, infection control