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Completed

NCT Number: NCT02909946

Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

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 .

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Key information

Conditions

Multi-antibiotic Resistance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan and partner nursing homes

Ann Arbor, Michigan, 48109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-modal Infection Control Program

Behavioral
  • 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).

Primary outcomes

  1. Prevalence density of multidrug-resistant organisms (MDRO)

    Time frame: 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 outcomes

  1. Incidence of multidrug-resistant organisms (MDRO)

    Time frame: 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

  2. Incidence of healthcare-associated infections

    Time frame: From 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2016
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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