Heart FailureNCT03843021
Ventricular Assist Device (VAD) Infection Prevention Survey
An observational study of Heart Failure and Healthcare Associated Infection, run by University of Michigan at 1 site in United States.
Trial summary
Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy. 60% of patients develop a healthcare-associated infection (HAI) within 90-days of implantation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Healthcare Associated Infection, Ventricular Assist Device
- What is being tested?
- VAD Infection Prevention Survey
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 23 Dec 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare providers involved in the medical management of a Ventricular Assist Device (VAD) recipient during the peri-operative period, specifically surgeons, cardiologist, VAD coordinators.
Who may be able to join
- Healthcare providers involved in the medical management of a Ventricular Assist Device (VAD) recipient during the peri-operative period, including those with the following roles: surgeons, cardiologists and VAD coordinators
Who cannot join
- Healthcare providers not caring for VAD recipient patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding and Addressing Variation in Healthcare-Associated Infections After Durable Ventricular Assist Device Therapy: Organizational: Aim 1 Survey
Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy. 60% of patients develop a healthcare-associated infection (HAI) within 90-days of implantation. The investigators long term goal is to develop and subsequently promote wide-scale adoption of evidence-based HAI prevention practices following durable VAD implantation.
This will be done by addressing the following aims:
Read more
Aim 1. Identify determinants of center-level variability in HAI rates. Aim 2. Develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates.
Aim 3. Develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.
The investigators will use a focused survey of U.S. VAD centers to identify determinants of center variation in 90-day HAI rates:
- Process Factors (e.g., intranasal mupirocin),
- Provider Factors (e.g., surgeon technique),
- Device Factors (e.g., centrifugal vs. axial),
- Center Factors (e.g., provider communication).
Understanding the barriers and facilitators within individual centers for maximizing adoption of prevention measures would serve as the foundation for targeted improvement strategies. Without this knowledge, evidence-based, action-oriented recommendations will have limited local adoption and ultimately effectiveness in preventing HAIs after VAD implantation.
Read the detailed description
Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy. Despite VADs providing long-term "durable" support, this therapy is associated with substantial risk (50% mortality at 4 years) and expense ($179,000 for inpatient services). Additionally, 60% of patients develop a healthcare-associated infection (HAI) within 90-days of implantation. Broad adoption of durable VAD therapy is hindered in part by HAIs, given associated sequelae (6-fold increased risk of 1-year mortality) and costs ($264,000 - $869,000 per patient). It is critical to determine how best to prevent HAIs in order to maximize the benefit of VAD therapy. While several studies have reported variation in HAI rates across centers after complex cardiac surgery, less is known in the setting of durable VADs. The average 90-day HAI rate after VAD implantation is as high as 19 events per 100 patient-months and varies (25th - 75th percentile, 9-23) across centers. While some argue that centers with lower HAI rates select healthier patients, others counter that improved practices (e.g., standardizing empirical and targeted antimicrobial therapy) or enhanced provider teamwork are more predictive of improved outcomes.
While evidence-based HAI prevention guidelines and implementation tools (e.g., checklists) exist, these approaches are not comprehensive (e.g., neglecting device-specific determinants) or customizable to local context, thus limiting usability, adoption, and likelihood of significant effectiveness for preventing HAIs. Understanding the barriers and facilitators within individual centers for maximizing adoption of prevention measures would serve as the foundation for targeted improvement strategies. Without this knowledge, evidence-based, action-oriented recommendations will have limited local adoption and ultimately effectiveness in preventing HAIs after VAD implantation.
The investigators long-term goal is to develop and subsequently promote wide-scale adoption of evidence-based HAI prevention practices following durable VAD implantation. The objective of this proposal is to identify prevention recommendations for the most significant HAIs after VAD implantation. To achieve this objective, the investigators will undertake a mixed methods study of adult patients receiving VADs in the U.S. from 2009 - 2017 and develop a modular toolkit of evidence-based recommendations. To determine best practices for preventing HAIs, the investigators will examine center-level differences in HAI rates to identify strategies used by centers with low rates, and potential barriers among centers with high rates.
- Being tested
- VAD Infection Prevention Survey
- Medical subject headings
- Heart Failure, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAD Infection Prevention SurveyOther
Healthcare providers caring for VAD Therapy recipients will answer questions regarding processes of care at their institutions.
| Study group | Role | What they receive |
|---|---|---|
| VAD Healthcare Providers | Adult healthcare providers of VAD therapy recipients. Receives: Other: VAD Infection Prevention Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
An organization's use of practices associated with center HAI rates.
We will use a survey to identify a center's use of practices that may explain their center's HAI rate
Measured: March 2019 - March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start29 May 2019
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Dr. Donald Likosky, University of Michigan
- Investigators
- Donald S Likosky, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843021
- Sponsor's protocol ID
- HUM00157335
- Status last verified
- Jul 2023
- First submitted
- 13 Feb 2019
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Addressing Variation in Healthcare-Associated Infections After Durable Ventricular Assist Device Therapy: Organizational: Aim 1 Survey
- ClinicalTrials.gov ID
- NCT03843021
- Acronym / sponsor ID
- HUM00157335
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 29 May 2019 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 15 Feb 2019 (actual)
- 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.
Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy. 60% of patients develop a healthcare-associated infection (HAI) within 90-days of implantation. The investigators long term goal is to develop and subsequently promote wide-scale adoption of evidence-based HAI prevention practices following durable VAD implantation.
This will be done by addressing the following aims:
Aim 1. Identify determinants of center-level variability in HAI rates. Aim 2. Develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates.
Aim 3. Develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.
The investigators will use a focused survey of U.S. VAD centers to identify determinants of center variation in 90-day HAI rates:
- Process Factors (e.g., intranasal mupirocin),
- Provider Factors (e.g., surgeon technique),
- Device Factors (e.g., centrifugal vs. axial),
- Center Factors (e.g., provider communication).
Understanding the barriers and facilitators within individual centers for maximizing adoption of prevention measures would serve as the foundation for targeted improvement strategies. Without this knowledge, evidence-based, action-oriented recommendations will have limited local adoption and ultimately effectiveness in preventing HAIs after VAD implantation.
Detailed description
Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy. Despite VADs providing long-term "durable" support, this therapy is associated with substantial risk (50% mortality at 4 years) and expense ($179,000 for inpatient services). Additionally, 60% of patients develop a healthcare-associated infection (HAI) within 90-days of implantation. Broad adoption of durable VAD therapy is hindered in part by HAIs, given associated sequelae (6-fold increased risk of 1-year mortality) and costs ($264,000 - $869,000 per patient). It is critical to determine how best to prevent HAIs in order to maximize the benefit of VAD therapy. While several studies have reported variation in HAI rates across centers after complex cardiac surgery, less is known in the setting of durable VADs. The average 90-day HAI rate after VAD implantation is as high as 19 events per 100 patient-months and varies (25th - 75th percentile, 9-23) across centers. While some argue that centers with lower HAI rates select healthier patients, others counter that improved practices (e.g., standardizing empirical and targeted antimicrobial therapy) or enhanced provider teamwork are more predictive of improved outcomes.
While evidence-based HAI prevention guidelines and implementation tools (e.g., checklists) exist, these approaches are not comprehensive (e.g., neglecting device-specific determinants) or customizable to local context, thus limiting usability, adoption, and likelihood of significant effectiveness for preventing HAIs. Understanding the barriers and facilitators within individual centers for maximizing adoption of prevention measures would serve as the foundation for targeted improvement strategies. Without this knowledge, evidence-based, action-oriented recommendations will have limited local adoption and ultimately effectiveness in preventing HAIs after VAD implantation.
The investigators long-term goal is to develop and subsequently promote wide-scale adoption of evidence-based HAI prevention practices following durable VAD implantation. The objective of this proposal is to identify prevention recommendations for the most significant HAIs after VAD implantation. To achieve this objective, the investigators will undertake a mixed methods study of adult patients receiving VADs in the U.S. from 2009 - 2017 and develop a modular toolkit of evidence-based recommendations. To determine best practices for preventing HAIs, the investigators will examine center-level differences in HAI rates to identify strategies used by centers with low rates, and potential barriers among centers with high rates.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAD Healthcare Providers | – | Other: VAD Infection Prevention SurveyAdult healthcare providers of VAD therapy recipients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare providers involved in the medical management of a Ventricular Assist Device (VAD) recipient during the peri-operative period, specifically surgeons, cardiologist, VAD coordinators.
Key inclusion criteria (1 listed)
- Healthcare providers involved in the medical management of a Ventricular Assist Device (VAD) recipient during the peri-operative period, including those with the following roles: surgeons, cardiologists and VAD coordinators
Key exclusion criteria (1 listed)
- Healthcare providers not caring for VAD recipient patients.
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 |
|---|---|---|
| VAD Infection Prevention SurveyHealthcare providers caring for VAD Therapy recipients will answer questions regarding processes of care at their institutions. | Other | VAD Healthcare Providers |
Primary outcome
An organization's use of practices associated with center HAI rates.
Time frame: March 2019 - March 2020
We will use a survey to identify a center's use of practices that may explain their center's HAI rate
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 14 Jul 2023.
- Individual participant dataSharing planned: No. We will not be sharing individual participant data
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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.
Donald S Likosky, Ph.D. 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?
An observational study of Heart Failure and Healthcare Associated 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 1 inclusion and 1 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 14 Jul 2023. 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?
An organization's use of practices associated with center HAI rates. (time frame: March 2019 - March 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2023.