Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

NCT ID: NCT02909946

Last Updated: 2018-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-15

Study Completion Date

2018-08-29

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).

Conditions

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Multi-antibiotic Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Arm

NHs randomized to the Intervention Arm will implement a new multi-modal infection control program.

Group Type ACTIVE_COMPARATOR

Multi-modal Infection Control Program

Intervention Type BEHAVIORAL

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).

Control Arm

NHs randomized to the Control Arm will continue their current standard infection control practices.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multi-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).

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Lona Mody

Principal Investigator, Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lona Mody, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan and partner nursing homes

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Wang J, Foxman B, Rao K, Cassone M, Gibson K, Mody L, Snitkin ES. Association of patient clinical and gut microbiota features with vancomycin-resistant enterococci environmental contamination in nursing homes: a retrospective observational study. Lancet Healthy Longev. 2023 Nov;4(11):e600-e607. doi: 10.1016/S2666-7568(23)00188-5.

Reference Type DERIVED
PMID: 37924841 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34269807 (View on PubMed)

Other Identifiers

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R01AG041780

Identifier Type: NIH

Identifier Source: org_study_id

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