Multi-antibiotic ResistanceNCT02909946
Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents
A study of Multi-antibiotic Resistance, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-antibiotic Resistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2016to 29 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Residing in a participating NH facility
- Provided informed consent for participation
Who cannot join
- Receiving end-of-life care
- Non-English language speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan and partner nursing homes
Ann Arbor, Michigan, 48109
About this study
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 .
Read the 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).
- Conditions
- Multi-antibiotic Resistance
- Being tested
- Multi-modal Infection Control Program
- Keywords
- multidrug-resistant organisms, nursing home, post-acute care, long-term care, infection control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal Infection Control ProgramBehavioural
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | NHs randomized to the Intervention Arm will implement a new multi-modal infection control program. Receives: Behavioral: Multi-modal Infection Control Program |
| Control Arm | No intervention | NHs randomized to the Control Arm will continue their current standard infection control practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: 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
Measured: From enrollment up to 6 months of study followup, or until study withdrawal (discharged from facility, at resident request, death)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start15 Sep 2016
- Primary completion15 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multi-antibiotic ResistanceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lona Mody, University of Michigan
- Investigators
- Lona Mody, MD, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909946
- Sponsor's protocol ID
- R01AG041780
- Status last verified
- Sep 2018
- First submitted
- 16 Aug 2016
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37924841Mody 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.
PubMed 34269807
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathway From Functional Disability to Antimicrobial Resistance in Nursing Home Residents
- ClinicalTrials.gov ID
- NCT02909946
- Acronym / sponsor ID
- R01AG041780
- Conditions
- Multi-antibiotic Resistance
- Keywords
- multidrug-resistant organisms, nursing home, post-acute care, long-term care, infection control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Behavioral: Multi-modal Infection Control ProgramNHs randomized to the Intervention Arm will implement a new multi-modal infection control program. |
| Control Arm | No intervention | –NHs randomized to the Control Arm will continue their current standard infection control practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Residing in a participating NH facility
- Provided informed consent for participation
Key exclusion criteria (2 listed)
- Receiving end-of-life care
- Non-English language speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal Infection Control Program1. 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). | Behavioural | Intervention Arm |
Primary outcome
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
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Derived from this study: PubMed 37924841Wang 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.
- Derived from this study: PubMed 34269807Mody 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lona Mody, MD, MSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Multi-antibiotic Resistance, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909946, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.