Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents

NCT02909946 | Completed

• 1 other identifier: R01AG041780
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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 .

Conditions

Multi-antibiotic Resistance

Keywords

multidrug-resistant organisms; nursing home; post-acute care; long-term care; infection control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• Incidence of healthcare-associated infections

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

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

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

Behavioral: Multi-modal Infection Control Program

Control Arm

NO INTERVENTION

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

Interventions

Multi-modal Infection Control Program 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).

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Residing in a participating NH facility
• Provided informed consent for participation

You may not qualify if:

• Receiving end-of-life care
• Non-English language speaking

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan and partner nursing homes

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• 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.

  PMID: 37924841 DERIVED

• 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.

  PMID: 34269807 DERIVED

Study Officials

• Lona Mody, MD, MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Internal Medicine

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: September 21, 2016
• Study Start: September 15, 2016
• Primary Completion: August 15, 2018
• Study Completion: August 29, 2018
• Last Updated: September 19, 2018

Record last verified: 2018-09

Locations

US (1)