Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

September 18, 2018 updated by: Lona Mody, University of Michigan
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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan and partner nursing homes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Arm
NHs randomized to the Intervention Arm will implement a new multi-modal infection control program.
Behavioral: 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).
No Intervention: Control Arm
NHs randomized to the Control Arm will continue their current standard infection control practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
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
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
From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Lona Mody, MD, MSc, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2016

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 29, 2018

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01AG041780 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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