InfectionsRECTIFYNCT05471973
CIED Infection Quality Initiative Demonstration Project
A study testing Multidisciplinary Team, Outreach Visits and Multifaceted Intervention in people with Infections, run by Duke University at 3 sites in United States.
Trial summary
The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections
- What is being tested?
- Multidisciplinary Team, Outreach Visits and Multifaceted Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 May 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Cardiovascular Implantable Electronic Device (CIED) in place
- Presumed CIED infection, as defined by:
- Positive blood culture (two or more positive blood cultures for typical skin organisms (coagulase-negative staphylococci, Corynebacterium species, Propionobacterium species), or one positive blood culture for all other microorganisms), with no other source identified to explain the bacteremia
- Cases with definite evidence of pocket infection (defined as localized erythema, swelling, pain, tenderness, warmth, erosion, or drainage), if treated with antibiotics before culture, even with negative culture, will be considered device infection
Who cannot join
- Patients who are inappropriate for device extraction, for example those who are DNAR and not using therapy to prolong survival because any procedure is considered inappropriate and/or it is unlikely that extraction would change overall prognosis
- Death within one week of definitive CIED systemic infection diagnosis or positive blood culture. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement should not be considered as CIED infection
- Patients with left ventricular assist devices (LVADs)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Atrium Health
Charlotte, North Carolina, 28203
Melissa Myers
Nicole Boisvert
- Recruiting
Northwestern
Chicago, Illinois, 60611
Anna Huskin, RN, BSN
Albert Lin, MD
- Not yet recruiting
Moses Cone
Greensboro, North Carolina, 27401
Cameron Lambert, MD
Cameron Lambert, MD
About this study
Official title: The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project
The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.
Read the detailed description
Retrospective data will be collected pre-intervention. The interventions will then be implemented for a total of six months and will continue through the data collection period. Prospective data collection will start three months after the intervention is started and will continue for a total of 12 months.
- Conditions
- Infections
- Being tested
- Multidisciplinary Team, Outreach Visits, Multifaceted Intervention, Measurement and Feedback
- Keywords
- Cardiac Implantable Electronic Devices, Quality improvement
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary TeamOther
Multidisciplinary team will be established that will define gaps in care, monitor ongoing data, identify barriers to guideline-directed care, and develop and implement multifaceted intervention to address the barriers
Outreach VisitsOther
An outreach visit consulting group from the coordinating center and trial leadership will provide external guidance on reviewing data, defining barriers, and implementing interventions
Multifaceted InterventionOther
These interventions are not limited to targeted engagement with non-extractors, electronic health record (EHR) decision support, creation of OR block time, use of opinion leaders, and development of clinical pathways. In addition, once patients are identified and referred to extraction centers, clinical pathways are needed to provide prompt care without clinical delay
Measurement and FeedbackOther
The coordinating center will provide ongoing feedback related to the site's data. This will include time to diagnosis, treatment, and outcomes related to the device infection.
| Study group | Role | What they receive |
|---|---|---|
| Quality Improvement Program | Other | The quality improvement program will consist of development and/or refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress. Receives: Other: Multidisciplinary Team; Other: Outreach Visits; Other: Multifaceted Intervention; Other: Measurement and Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)
Proportion of patients with CIEDs and positive blood cultures, who receive extraction
Measured: Up to 12 months
Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines)
Proportion of patients with CIEDs and probable device infection, who receive extraction
Measured: Up to 12 months
Secondary outcomes (10)
Proportion of patients with extraction within 7 days of diagnosis
Proportion of patients who who receive extraction within 7 days and during index hospitalization
Measured: Up to 12 months
Proportion of patients with extraction during index hospitalization
Measured: Up to 12 months
Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction
Measured: Up to 12 months
Number of patients identified with suspected CIED infection
Measured: Up to 12 months
Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction
Measured: Up to 12 months
Number of actual extractions
Measured: Up to 12 months
Number of patients with multi-organ failure or septic shock at time of extraction
Measured: Up to 12 months
Estimated healthcare utilization/costs
Measured: Up to 12 months
Staff satisfaction as measured by a qualitative survey
Measured: Up to 12 months
Patient satisfaction as measured by a qualitative survey
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start10 May 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Chris Granger, MD, Principal investigator, Duke Clinical Research InstituteSean Pokorney, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471973
- Sponsor's protocol ID
- Pro00110118
- Acronym
- RECTIFY
- Status last verified
- May 2026
- First submitted
- 21 Jul 2022
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osude N, Granger CB, Young R, Al-Khalidil H, Ward K, Leyva M, Lambert C, Tillery M, Lin A, Mehta R, Satish M, Peigh G, Wright A, Epstein LM, Lundqvist CB, Piccini JP, Sohail MR, Pokorney SD. REview and improvement of cardiac implanTable device Infection management qualitY initiative (RECTIFY): Rationale and design for a cardiac implantable electronic device infection quality initiative demonstration project. Am Heart J. 2026 Feb;292:107264. doi: 10.1016/j.ahj.2025.08.017. Epub 2025 Aug 26.
PubMed 40876585
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project
- ClinicalTrials.gov ID
- NCT05471973
- Acronym / sponsor ID
- RECTIFY / Pro00110118
- Conditions
- Infections
- Keywords
- Cardiac Implantable Electronic Devices, Quality improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, Philips Healthcare
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Jul 2022 (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.
The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.
Detailed description
Retrospective data will be collected pre-intervention. The interventions will then be implemented for a total of six months and will continue through the data collection period. Prospective data collection will start three months after the intervention is started and will continue for a total of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality Improvement Program | Other | Other: Multidisciplinary Team, Other: Outreach Visits, Other: Multifaceted Intervention, Other: Measurement and FeedbackThe quality improvement program will consist of development and/or refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Cardiovascular Implantable Electronic Device (CIED) in place
- Presumed CIED infection, as defined by:
Key exclusion criteria (3 listed)
- Patients who are inappropriate for device extraction, for example those who are DNAR and not using therapy to prolong survival because any procedure is considered inappropriate and/or it is unlikely that extraction would change overall prognosis
- Death within one week of definitive CIED systemic infection diagnosis or positive blood culture. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement should not be considered as CIED infection
- Patients with left ventricular assist devices (LVADs)
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 |
|---|---|---|
| Multidisciplinary TeamMultidisciplinary team will be established that will define gaps in care, monitor ongoing data, identify barriers to guideline-directed care, and develop and implement multifaceted intervention to address the barriers | Other | Quality Improvement Program |
| Outreach VisitsAn outreach visit consulting group from the coordinating center and trial leadership will provide external guidance on reviewing data, defining barriers, and implementing interventions | Other | Quality Improvement Program |
| Multifaceted InterventionThese interventions are not limited to targeted engagement with non-extractors, electronic health record (EHR) decision support, creation of OR block time, use of opinion leaders, and development of clinical pathways. In addition, once patients are identified and referred to extraction centers, clinical pathways are needed to provide prompt care without clinical delay | Other | Quality Improvement Program |
| Measurement and FeedbackThe coordinating center will provide ongoing feedback related to the site's data. This will include time to diagnosis, treatment, and outcomes related to the device infection. | Other | Quality Improvement Program |
Primary outcome
Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)
Time frame: Up to 12 months
Proportion of patients with CIEDs and positive blood cultures, who receive extraction
Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines)
Time frame: Up to 12 months
Proportion of patients with CIEDs and probable device infection, who receive extraction
10 secondary outcomes
Proportion of patients with extraction within 7 days of diagnosis
Time frame: Up to 12 months
Proportion of patients with extraction during index hospitalization
Time frame: Up to 12 months
Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction
Time frame: Up to 12 months
Number of patients identified with suspected CIED infection
Time frame: Up to 12 months
Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction
Time frame: Up to 12 months
Number of actual extractions
Time frame: Up to 12 months
Number of patients with multi-organ failure or septic shock at time of extraction
Time frame: Up to 12 months
Estimated healthcare utilization/costs
Time frame: Up to 12 months
Staff satisfaction as measured by a qualitative survey
Time frame: Up to 12 months
Patient satisfaction as measured by a qualitative survey
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 40876585Osude N, Granger CB, Young R, Al-Khalidil H, Ward K, Leyva M, Lambert C, Tillery M, Lin A, Mehta R, Satish M, Peigh G, Wright A, Epstein LM, Lundqvist CB, Piccini JP, Sohail MR, Pokorney SD. REview and improvement of cardiac implanTable device Infection management qualitY initiative (RECTIFY): Rationale and design for a cardiac implantable electronic device infection quality initiative demonstration project. Am Heart J. 2026 Feb;292:107264. doi: 10.1016/j.ahj.2025.08.017. Epub 2025 Aug 26.
- Individual participant dataSharing planned: No
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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.
Chris Granger, MD principal investigator
Duke Clinical Research Institute
Sean Pokorney, MD principal investigator
Duke Clinical Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Team, Outreach Visits and Multifaceted Intervention in people with Infections, run by Duke University at 3 sites 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 5 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Ward, MPH (9196606409, kimberly.t.ward@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines) (time frame: Up to 12 months). The study lists 2 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 NCT05471973, which also lists 1 linked publication.
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 6 May 2026.