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CIED Infection Quality Initiative Demonstration Project (RECTIFY)

Primary Purpose

Infections

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Multidisciplinary Team

Outreach Visits

Multifaceted Intervention

Measurement and Feedback

About this trial

This is an interventional treatment trial for Infections focused on measuring Cardiac Implantable Electronic Devices, Quality improvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 years
Cardiovascular Implantable Electronic Device (CIED) in place
Presumed CIED infection, as defined by:
1. 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
2. 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

Exclusion Criteria:

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)

Sites / Locations

NorthwesternRecruiting
Atrium Health
Moses Cone

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Quality Improvement Program

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Proportion of patients with extraction within 7 days of diagnosis

Proportion of patients who who receive extraction within 7 days and during index hospitalization

Proportion of patients with extraction during index hospitalization

Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction

Number of patients identified with suspected CIED infection

Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction

Number of actual extractions

Number of patients with multi-organ failure or septic shock at time of extraction

Estimated healthcare utilization/costs

Staff satisfaction as measured by a qualitative survey

Patient satisfaction as measured by a qualitative survey

Full Information

NCT ID

NCT05471973

First Posted

July 21, 2022

Last Updated

July 21, 2023

Sponsor

Duke University

Collaborators

Duke Clinical Research Institute, Philips Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT05471973

Brief Title

CIED Infection Quality Initiative Demonstration Project

Acronym

RECTIFY

Official Title

The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 10, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Duke Clinical Research Institute, Philips Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections

Keywords

Cardiac Implantable Electronic Devices, Quality improvement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Quality Improvement Program

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Multidisciplinary Team

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Outreach Visits

Intervention Description

An outreach visit consulting group from the coordinating center and trial leadership will provide external guidance on reviewing data, defining barriers, and implementing interventions

Intervention Type

Other

Intervention Name(s)

Multifaceted Intervention

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Measurement and Feedback

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)

Description

Proportion of patients with CIEDs and positive blood cultures, who receive extraction

Time Frame

Up to 12 months

Title

Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines)

Description

Proportion of patients with CIEDs and probable device infection, who receive extraction

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Proportion of patients with extraction within 7 days of diagnosis

Description

Proportion of patients who who receive extraction within 7 days and during index hospitalization

Time Frame

Up to 12 months

Title

Proportion of patients with extraction during index hospitalization

Time Frame

Up to 12 months

Title

Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction

Time Frame

Up to 12 months

Title

Number of patients identified with suspected CIED infection

Time Frame

Up to 12 months

Title

Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction

Time Frame

Up to 12 months

Title

Number of actual extractions

Time Frame

Up to 12 months

Title

Number of patients with multi-organ failure or septic shock at time of extraction

Time Frame

Up to 12 months

Title

Estimated healthcare utilization/costs

Time Frame

Up to 12 months

Title

Staff satisfaction as measured by a qualitative survey

Time Frame

Up to 12 months

Title

Patient satisfaction as measured by a qualitative survey

Time Frame

Up to 12 months

Other Pre-specified Outcome Measures:

Title

Mortality

Description

Number of deaths from CIED infection

Time Frame

Up to 12 months

Title

Length of stay

Description

Clinical outcomes: number of days of hospitalization

Time Frame

Up to 12 months

Title

Days of antibiotic treatments

Description

Number of days patient received antibiotics

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kimberly Ward, MPH

Phone

9196606409

kimberly.t.ward@duke.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Brady

Phone

9196818928

sarah.brady@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chris Granger, MD

Organizational Affiliation

Duke Clinical Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sean Pokorney, MD

Organizational Affiliation

Duke Clinical Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Huskin, RN, BSN

First Name & Middle Initial & Last Name & Degree

Albert Lin, MD

Facility Name

Atrium Health

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Myers

First Name & Middle Initial & Last Name & Degree

Nicole Boisvert

First Name & Middle Initial & Last Name & Degree

Rohit Mehta, MD

First Name & Middle Initial & Last Name & Degree

Satish Misra, MD

Facility Name

Moses Cone

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cameron Lambert, MD

First Name & Middle Initial & Last Name & Degree

Cameron Lambert, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

CIED Infection Quality Initiative Demonstration Project

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