Cardiovascular Innovation & Research Institute 's NEXUS Registry, the Whole is Greater Than the Parts.
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/11/2018 |
| Start Date: | March 2016 |
| End Date: | March 2026 |
| Contact: | Kim M Williams, MPH |
| Email: | kim.williams@vvh.org |
| Phone: | 970-384-7433 |
NEXUS Registry: An Outcomes Database Which Tracks Patient -Reported Outcomes After Percutaneous Coronary Intervention for Coronary Artery Disease Along With Surgical and Subcutaneous Ablation for the Management of Atrial Fibrillation.
Information gathered from the patients via a disease specific questionnaire will be married
to data from the National Cardiovascular Data Registry (NCDR®). Details will be continuously
analyzed and used to direct quality of care at our center. Our institution is categorized as
a low-volume institution for percutaneous coronary intervention (PCI) for coronary artery
disease treatment as well as surgical and endocardial ablation for the management of atrial
fibrillation (Afib). The association between operator volume and quality has primarily
focused on rare complications, such as mortality. Our aim is to highlight the advantages of
receiving care close to home. A benefit of offering the procedures to treat diseases at
centers that have lower volumes is to improve patients' outcomes while also providing more
convenient access to quality care. The key outcome from the patients' experience is
alleviation of their symptoms while increasing function and quality of life. To date, there
have been no studies documenting the health status benefits of PCI and surgical / endocardial
ablation for coronary artery disease and Afib, respectively with low- volume operators. In
this study, we sought to examine the feasibility of implementing patient-reported outcomes
into clinical care and to demonstrate evidence of benefits, from patients' perspectives, of
receiving treatment by low-volume operators.
to data from the National Cardiovascular Data Registry (NCDR®). Details will be continuously
analyzed and used to direct quality of care at our center. Our institution is categorized as
a low-volume institution for percutaneous coronary intervention (PCI) for coronary artery
disease treatment as well as surgical and endocardial ablation for the management of atrial
fibrillation (Afib). The association between operator volume and quality has primarily
focused on rare complications, such as mortality. Our aim is to highlight the advantages of
receiving care close to home. A benefit of offering the procedures to treat diseases at
centers that have lower volumes is to improve patients' outcomes while also providing more
convenient access to quality care. The key outcome from the patients' experience is
alleviation of their symptoms while increasing function and quality of life. To date, there
have been no studies documenting the health status benefits of PCI and surgical / endocardial
ablation for coronary artery disease and Afib, respectively with low- volume operators. In
this study, we sought to examine the feasibility of implementing patient-reported outcomes
into clinical care and to demonstrate evidence of benefits, from patients' perspectives, of
receiving treatment by low-volume operators.
This is a prospective cohort, time series analysis of the routine procedures associated with
our catheterization and electrophysiology lab through ten years post intervention. Our goal
is to demonstrate clinical effectiveness with cardiac service line with low-volume operators.
A connection between NCDR with applied clinical research that directs continuous quality
improvement goals and objectives is the ideal setting for value-based, quality care. The
system of diagnosing, treating and tracking individuals with cardiovascular and pacing
disease has many facets which could benefit from continuous quality improvement and outcomes
analysis. The proposed Valley View NEXUS outcomes registry will bridge national data to our
local clinical data. Clinical registries are a methodically sound instrument for measuring
and improving performance. Registries are efficacious for surveillance, measuring
effectiveness of quality improvement initiatives, identifying determinates of quality of life
and function while synergistically increasing the value of health care expenditures with
respect to heart disease, stroke, and arrhythmias.
The Schulman Institutional Review Board (IRB) reviewed our protocol, and authorized the
study. Once informed consent was obtained, eligible adults scheduled for diagnostic
angiography with possible PCI completed a baseline patient reported outcome assessment and
again at designated follow-up intervals (six months and annually thereafter for up to ten
years). Due to the urgent nature of STEMI- PCI procedures, it was determined that informed
consent prior to PCI was prohibitive; however after consideration, the protocol was amended
to capture baseline assessments immediately following PCI while the patient 's status was in
hospital with use of the Seattle Angina Questionnaire (SAQ) and the Veterans Rand 12-Item
Health Survey (VR-12). The SAQ is recognized as a disease specific questionnaire for coronary
artery disease. The SAQ is a six item questionnaire that assesses patient's function,
symptoms, and satisfaction. A higher score translates to better outcomes. The VR-12 is a
twelve item questionnaire used to assess quality of life. A lower score translates to a
higher quality of life in relation to a person's health and wellness. Combining data from a
disease specific questionnaire, quality of life assessment, and the NCDR's CathPCI® Registry
serves as a nexus between big data and the individual patient experience. From January 2015
through December 2017, twenty- two patients have been enrolled. Based on the data from the
first six patients to provide scores both at baseline and month six and with a study design
to have 90% power to detect a change in the overall SAQ score of 10 points at six months, it
was determined 49 patients will need to be enrolled.
The aforementioned methodology will be applied for surgical and endocardial ablations for
patients' with Afib. Presently, enrollment is open for Afib patients and data being captured
will be analyzed to determine sample size. Patients who receive intervention for management
Afib will complete the Atrial Fibrillation Effect on Quality -of-life (AFEQT) Questionnaire
and the VR-12. Again the VR-12 is a twelve item questionnaire used to assess quality of life.
A lower score translates to a higher quality of life in relation to a person's health and
wellness. The AFEQT is recognized as a disease specific questionnaire for Afib. A higher
score translates to worse symptoms and limitations in daily function associated with Afib.
Combining the outcomes metric with NCDR's Afib Ablation Registry ® allows our institution
demonstrative effective outcomes for low-volume operators.
The data validation process applies to both PCI and surgical and/or endocardial ablation and
is as follows:
1. Quality Assurance Plan Training for staff that populates both data registries is
ongoing. Staff will participate in the NCDR® applicable training modules. Documentation
of training will be maintained in the study coordinator's office. Agreeing to
participate with the NCDR®, an institution also agrees to random site monitoring and/or
audits.
2. Data Checks All patients who agree to participate in NEXUS outcomes registry and
subsequent statistical analysis will experience a complete date audit for both outcomes
assessments and NCDR® data elements. NCDR® has algorithm limits for both CathPCI®
Registry and Afib Ablation ® Registry. All registry elements require abstraction form
Meditech source documents. Reports are titled Cardiology Procedure Note and
Electrophysiology Procedure Note for PCI and Afib ablation, respectively.
Quality/outcome metrics will be sampled in paper form -the sources documents.
Information will then be populated into excel for scoring. All paper forms will be
maintained for the life of the study.
3. Data Dictionary Complete Data Dictionaries are provided by NCDR® with data element
numbers and associated limits and acceptable values for both Cath PCI ® and Afib
Ablation ® Registry.
4. Standard Operating Procedures A complete NEXUS Registry Protocol will be on site held in
the Cardiovascular Innovation & Research Institute at Valley View Hospital along with
all regulatory information, lab certifications, training documents, IRB documents,
license agreements, analytic agreements and process maps for informed consent for
outcomes research. Note NCDR® registries obtained a waiver for informed consent.
5. Sample Size Assessment The number of patients necessary to demonstrate an effect for
outcomes after PCI with low-volume operators is 49.
Presently, outcomes after surgical and/or endocardial ablation are being piloted to
determine sample size for a study powered at 90%.
6. Missing Data Every attempt will be made to reach patients to ensure they are not lost to
follow-up. Statistical consult recommends last observation carried forward for missing
data.
7. Statistical Analysis Plan. For the primary analysis, the 6-month change in mean SAQ will
be tested using a 1-sample upper 1-sided t-test. With 49 completers the t-test will have
90.4% power to detect an improvement in mean SAQ score of 10 points. A linear regression
model will be used for the secondary analysis to investigate factors which are
associated with the 6-month change (month 6 - baseline) in mean SAQ score. Factors which
will be investigated for inclusion in the model include sex, age, physician American
Society Anesthesiologists (ASA) class, physician volume, access site, and Charlson
comorbidity index. An all-possible regressions approach will be used during the model
building process in which all possible regression models are fit. The models will then
be evaluated using Mallows' Cp statistic where models with values of Cp less than p (the
number of parameters) will be considered as strong candidates for the final model. The
final model will be selected after considering both results from the model selection
process and subject matter knowledge. The regression analysis will have greater power
than the t-test used in the sample size justification due to the reduction in
variability of the outcome measure by including additional factors in a regression
model. Additional analyses include [need to add specifics here]. All analyses will be
conducted using SAS 9.4M4 or greater software (SAS Institute, Inc., Cary, NC, USA).
Morbidity / Complications will be reported included but not limited to bleeding at access
site, hematoma, cardiac tamponade, vascular perforation, peripheral vascular injuries, post
procedure hematoma, and mortality.
Statistical Analysis Plan with Respect to Surgical and/ or Endocardial Ablation for Afib
This outcomes registry is in its early pilot analysis for Afib and hypothesis generating. For
the primary analysis, the six-month change in mean AFEQT scores will be analyzed.
our catheterization and electrophysiology lab through ten years post intervention. Our goal
is to demonstrate clinical effectiveness with cardiac service line with low-volume operators.
A connection between NCDR with applied clinical research that directs continuous quality
improvement goals and objectives is the ideal setting for value-based, quality care. The
system of diagnosing, treating and tracking individuals with cardiovascular and pacing
disease has many facets which could benefit from continuous quality improvement and outcomes
analysis. The proposed Valley View NEXUS outcomes registry will bridge national data to our
local clinical data. Clinical registries are a methodically sound instrument for measuring
and improving performance. Registries are efficacious for surveillance, measuring
effectiveness of quality improvement initiatives, identifying determinates of quality of life
and function while synergistically increasing the value of health care expenditures with
respect to heart disease, stroke, and arrhythmias.
The Schulman Institutional Review Board (IRB) reviewed our protocol, and authorized the
study. Once informed consent was obtained, eligible adults scheduled for diagnostic
angiography with possible PCI completed a baseline patient reported outcome assessment and
again at designated follow-up intervals (six months and annually thereafter for up to ten
years). Due to the urgent nature of STEMI- PCI procedures, it was determined that informed
consent prior to PCI was prohibitive; however after consideration, the protocol was amended
to capture baseline assessments immediately following PCI while the patient 's status was in
hospital with use of the Seattle Angina Questionnaire (SAQ) and the Veterans Rand 12-Item
Health Survey (VR-12). The SAQ is recognized as a disease specific questionnaire for coronary
artery disease. The SAQ is a six item questionnaire that assesses patient's function,
symptoms, and satisfaction. A higher score translates to better outcomes. The VR-12 is a
twelve item questionnaire used to assess quality of life. A lower score translates to a
higher quality of life in relation to a person's health and wellness. Combining data from a
disease specific questionnaire, quality of life assessment, and the NCDR's CathPCI® Registry
serves as a nexus between big data and the individual patient experience. From January 2015
through December 2017, twenty- two patients have been enrolled. Based on the data from the
first six patients to provide scores both at baseline and month six and with a study design
to have 90% power to detect a change in the overall SAQ score of 10 points at six months, it
was determined 49 patients will need to be enrolled.
The aforementioned methodology will be applied for surgical and endocardial ablations for
patients' with Afib. Presently, enrollment is open for Afib patients and data being captured
will be analyzed to determine sample size. Patients who receive intervention for management
Afib will complete the Atrial Fibrillation Effect on Quality -of-life (AFEQT) Questionnaire
and the VR-12. Again the VR-12 is a twelve item questionnaire used to assess quality of life.
A lower score translates to a higher quality of life in relation to a person's health and
wellness. The AFEQT is recognized as a disease specific questionnaire for Afib. A higher
score translates to worse symptoms and limitations in daily function associated with Afib.
Combining the outcomes metric with NCDR's Afib Ablation Registry ® allows our institution
demonstrative effective outcomes for low-volume operators.
The data validation process applies to both PCI and surgical and/or endocardial ablation and
is as follows:
1. Quality Assurance Plan Training for staff that populates both data registries is
ongoing. Staff will participate in the NCDR® applicable training modules. Documentation
of training will be maintained in the study coordinator's office. Agreeing to
participate with the NCDR®, an institution also agrees to random site monitoring and/or
audits.
2. Data Checks All patients who agree to participate in NEXUS outcomes registry and
subsequent statistical analysis will experience a complete date audit for both outcomes
assessments and NCDR® data elements. NCDR® has algorithm limits for both CathPCI®
Registry and Afib Ablation ® Registry. All registry elements require abstraction form
Meditech source documents. Reports are titled Cardiology Procedure Note and
Electrophysiology Procedure Note for PCI and Afib ablation, respectively.
Quality/outcome metrics will be sampled in paper form -the sources documents.
Information will then be populated into excel for scoring. All paper forms will be
maintained for the life of the study.
3. Data Dictionary Complete Data Dictionaries are provided by NCDR® with data element
numbers and associated limits and acceptable values for both Cath PCI ® and Afib
Ablation ® Registry.
4. Standard Operating Procedures A complete NEXUS Registry Protocol will be on site held in
the Cardiovascular Innovation & Research Institute at Valley View Hospital along with
all regulatory information, lab certifications, training documents, IRB documents,
license agreements, analytic agreements and process maps for informed consent for
outcomes research. Note NCDR® registries obtained a waiver for informed consent.
5. Sample Size Assessment The number of patients necessary to demonstrate an effect for
outcomes after PCI with low-volume operators is 49.
Presently, outcomes after surgical and/or endocardial ablation are being piloted to
determine sample size for a study powered at 90%.
6. Missing Data Every attempt will be made to reach patients to ensure they are not lost to
follow-up. Statistical consult recommends last observation carried forward for missing
data.
7. Statistical Analysis Plan. For the primary analysis, the 6-month change in mean SAQ will
be tested using a 1-sample upper 1-sided t-test. With 49 completers the t-test will have
90.4% power to detect an improvement in mean SAQ score of 10 points. A linear regression
model will be used for the secondary analysis to investigate factors which are
associated with the 6-month change (month 6 - baseline) in mean SAQ score. Factors which
will be investigated for inclusion in the model include sex, age, physician American
Society Anesthesiologists (ASA) class, physician volume, access site, and Charlson
comorbidity index. An all-possible regressions approach will be used during the model
building process in which all possible regression models are fit. The models will then
be evaluated using Mallows' Cp statistic where models with values of Cp less than p (the
number of parameters) will be considered as strong candidates for the final model. The
final model will be selected after considering both results from the model selection
process and subject matter knowledge. The regression analysis will have greater power
than the t-test used in the sample size justification due to the reduction in
variability of the outcome measure by including additional factors in a regression
model. Additional analyses include [need to add specifics here]. All analyses will be
conducted using SAS 9.4M4 or greater software (SAS Institute, Inc., Cary, NC, USA).
Morbidity / Complications will be reported included but not limited to bleeding at access
site, hematoma, cardiac tamponade, vascular perforation, peripheral vascular injuries, post
procedure hematoma, and mortality.
Statistical Analysis Plan with Respect to Surgical and/ or Endocardial Ablation for Afib
This outcomes registry is in its early pilot analysis for Afib and hypothesis generating. For
the primary analysis, the six-month change in mean AFEQT scores will be analyzed.
Inclusion Criteria:
Candidates will be included in the study only if all the following conditions are met:
1. Age >18 years
2. The subject has been informed of the nature of the study, agrees to its provisions, is
able to comprehend, and has provided informed consent.
3. The subject is available for follow-up.
4. The subject has a diagnosis of coronary artery disease or Afib.
Exclusion Criteria:
Candidates will be excluded from the study if any of the following conditions are present:
1. Failure and / or inability and / or unwillingness to provide informed consent.
2. Likely problems, in the judgement of the investigators, with maintaining follow-up.
We found this trial at
1
site
Glenwood Springs, Colorado 81601
Principal Investigator: Frank A Laws, MD
Phone: 970-384-7433
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