InfectionNCT01062841
Targeted Infection Control in Long-term Care
A study of Infection, run by University of Michigan at 1 site in United States.
Trial summary
This is an interventional study aimed at reducing multi-drug resistance and infections in nursing home (NH) residents. Each year, a staggering 1.5-2.0 million infections occur in NHs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Any short- or long-stay resident with an indwelling urinary catheter or feeding tube for more than 72 hours
- Ability to get informed consent from either the resident or his/her durable power of attorney
Who cannot join
- Having an indwelling device for less than 72 hours
- Refusal of consent to get surveillance cultures and data collection by the resident or his/her durable power of attorney
- Residents who are receiving end-of-life care
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
Official title: Targeted Infection Control Program (TIP) to Reduce Resistant Pathogens and Infections
This is an interventional study aimed at reducing multi-drug resistance and infections in nursing home (NH) residents. Each year, a staggering 1.5-2.0 million infections occur in NHs. Many of these infections are caused by multiple drug resistant organisms (MDROs) including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and multidrug resistant Gram-negative bacilli (R-GNB). Antimicrobial resistance among common bacteria are adversely affecting the clinical course and exponentially increasing healthcare costs. Recognizing a need for action, legislators, policy makers, and consumer groups are advocating for pathogen-based universal preemptive screening for these MDROs, particularly MRSA in hospitals and NHs. However, implementing this sweeping mandate is controversial, costly, reactive, and not based on empirical evidence. It can result in a 10-20-fold increase in the number of NH residents placed in isolation precautions with the potential for reduced attention by healthcare workers, isolation and functional decline. The investigators proposal evaluates a novel focused approach between 'do nothing' and 'search all and destroy' strategies by targeting a subgroup of NH residents with indwelling devices who are at a high risk of acquiring MDROs and infections.
The investigators hypothesize that the investigators targeted infection control program (TIP) will reduce MDRO colonization and infections in NH residents with indwelling devices. This cluster randomized trial will involve 12 NHs; 6 will be randomized to the TIP arm and 6 to the routine care arm. The investigators TIP intervention will include four components.
Read the detailed description
Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program.
Component 4: A structured educational program pertaining to indwelling device care for healthcare workers.
- Conditions
- Infection
- Being tested
- Targeted Infection Control
- Keywords
- Long-Term Care, Nursing Homes, Infection Control, Multi-drug resistant pathogens, Long-term care residents with in-dwelling devices
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Infection ControlBehavioural
Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Targeted Infection Control | Active comparator | Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs. Receives: Behavioral: Targeted Infection Control |
| Control | No intervention | Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of MDRO (Multidrug Resistant Organisms) Isolated
Total Number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents with indwelling devices over the duration of the study period
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of VRE (Vancomycin Resistant Enterococci) Isolated
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Secondary outcomes (7)
Number of First Incident Urinary Catheter-associated Urinary Tract Infections
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Number of Incident Feeding-tube Associated Pneumonias
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition
Measured: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 418 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, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062841
- Sponsor's protocol ID
- AG032298-01A1
- Status last verified
- Aug 2016
- First submitted
- 2 Feb 2010
- Last updated
- 29 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hutton DW, Krein SL, Saint S, Graves N, Kolli A, Lynem R, Mody L. Economic Evaluation of a Catheter-Associated Urinary Tract Infection Prevention Program in Nursing Homes. J Am Geriatr Soc. 2018 Apr;66(4):742-747. doi: 10.1111/jgs.15316. Epub 2018 Feb 28.
PubMed 29489017Cassone M, McNamara SE, Perri MB, Zervos M, Mody L. Impact of Intervention Measures on MRSA Clonal Type and Carriage Site Prevalence. mBio. 2016 Mar 8;7(2):e00218. doi: 10.1128/mBio.00218-16. No abstract available.
PubMed 26956588Ismail MD, Luo T, McNamara S, Lansing B, Koo E, Mody L, Foxman B. Long-Term Carriage of Ciprofloxacin-Resistant Escherichia coli Isolates in High-Risk Nursing Home Residents. Infect Control Hosp Epidemiol. 2016 Apr;37(4):440-7. doi: 10.1017/ice.2015.326. Epub 2016 Jan 19.
PubMed 26782632Mody L, Krein SL, Saint S, Min LC, Montoya A, Lansing B, McNamara SE, Symons K, Fisch J, Koo E, Rye RA, Galecki A, Kabeto MU, Fitzgerald JT, Olmsted RN, Kauffman CA, Bradley SF. A targeted infection prevention intervention in nursing home residents with indwelling devices: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):714-23. doi: 10.1001/jamainternmed.2015.132.
PubMed 25775048
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Infection Control Program (TIP) to Reduce Resistant Pathogens and Infections
- ClinicalTrials.gov ID
- NCT01062841
- Acronym / sponsor ID
- AG032298-01A1
- Conditions
- Infection
- Keywords
- Long-Term Care, Nursing Homes, Infection Control, Multi-drug resistant pathogens, Long-term care residents with in-dwelling devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Posted 29 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional study aimed at reducing multi-drug resistance and infections in nursing home (NH) residents. Each year, a staggering 1.5-2.0 million infections occur in NHs. Many of these infections are caused by multiple drug resistant organisms (MDROs) including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and multidrug resistant Gram-negative bacilli (R-GNB). Antimicrobial resistance among common bacteria are adversely affecting the clinical course and exponentially increasing healthcare costs. Recognizing a need for action, legislators, policy makers, and consumer groups are advocating for pathogen-based universal preemptive screening for these MDROs, particularly MRSA in hospitals and NHs. However, implementing this sweeping mandate is controversial, costly, reactive, and not based on empirical evidence. It can result in a 10-20-fold increase in the number of NH residents placed in isolation precautions with the potential for reduced attention by healthcare workers, isolation and functional decline. The investigators proposal evaluates a novel focused approach between 'do nothing' and 'search all and destroy' strategies by targeting a subgroup of NH residents with indwelling devices who are at a high risk of acquiring MDROs and infections.
The investigators hypothesize that the investigators targeted infection control program (TIP) will reduce MDRO colonization and infections in NH residents with indwelling devices. This cluster randomized trial will involve 12 NHs; 6 will be randomized to the TIP arm and 6 to the routine care arm. The investigators TIP intervention will include four components.
Detailed description
Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.
Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.
Component 3: A hand hygiene promotion program.
Component 4: A structured educational program pertaining to indwelling device care for healthcare workers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Targeted Infection Control | Active comparator | Behavioral: Targeted Infection ControlNursing homes allocated to the Intervention Arm will implement a series of new infection control programs. |
| Control | No intervention | –Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any short- or long-stay resident with an indwelling urinary catheter or feeding tube for more than 72 hours
- Ability to get informed consent from either the resident or his/her durable power of attorney
Key exclusion criteria (3 listed)
- Having an indwelling device for less than 72 hours
- Refusal of consent to get surveillance cultures and data collection by the resident or his/her durable power of attorney
- Residents who are receiving end-of-life care
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 |
|---|---|---|
| Targeted Infection ControlComponent 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration. Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration. Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers. | Behavioural | Intervention: Targeted Infection Control |
Primary outcome
Total Number of MDRO (Multidrug Resistant Organisms) Isolated
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents with indwelling devices over the duration of the study period
Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of VRE (Vancomycin Resistant Enterococci) Isolated
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
7 secondary outcomes
Number of First Incident Urinary Catheter-associated Urinary Tract Infections
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Number of Incident Feeding-tube Associated Pneumonias
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition
Time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29489017Hutton DW, Krein SL, Saint S, Graves N, Kolli A, Lynem R, Mody L. Economic Evaluation of a Catheter-Associated Urinary Tract Infection Prevention Program in Nursing Homes. J Am Geriatr Soc. 2018 Apr;66(4):742-747. doi: 10.1111/jgs.15316. Epub 2018 Feb 28.
- Derived from this study: PubMed 26956588Cassone M, McNamara SE, Perri MB, Zervos M, Mody L. Impact of Intervention Measures on MRSA Clonal Type and Carriage Site Prevalence. mBio. 2016 Mar 8;7(2):e00218. doi: 10.1128/mBio.00218-16. No abstract available.
- Derived from this study: PubMed 26782632Ismail MD, Luo T, McNamara S, Lansing B, Koo E, Mody L, Foxman B. Long-Term Carriage of Ciprofloxacin-Resistant Escherichia coli Isolates in High-Risk Nursing Home Residents. Infect Control Hosp Epidemiol. 2016 Apr;37(4):440-7. doi: 10.1017/ice.2015.326. Epub 2016 Jan 19.
- Derived from this study: PubMed 25775048Mody L, Krein SL, Saint S, Min LC, Montoya A, Lansing B, McNamara SE, Symons K, Fisch J, Koo E, Rye RA, Galecki A, Kabeto MU, Fitzgerald JT, Olmsted RN, Kauffman CA, Bradley SF. A targeted infection prevention intervention in nursing home residents with indwelling devices: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):714-23. doi: 10.1001/jamainternmed.2015.132.
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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 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 Infection, 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 2 inclusion and 3 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 29 Sep 2016. 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?
Yes. Results are posted in the registry (first posted 29 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of MDRO (Multidrug Resistant Organisms) Isolated (time frame: From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study). The study lists 5 primary outcomes in all. 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 NCT01062841, which also lists 4 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 29 Sep 2016.