Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
750 participants
INTERVENTIONAL
2023-09-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Education alone
No interventions assigned to this group
Education + decision support to provide suggestions for care optimization
Decision support
This implementation strategy will include the clinician education of the previous arm and apply "audit and feedback" of prior care to inform recommendations for future care. These suggestions will encompass 5 different domains based on eligibility and potential opportunity for an SGLT2i, GLP-1RA, angiotensin converting enzyme inhibitors (ACEi)/angiotensin-receptor blockers (ARB), antiplatelet or antithrombotic therapy, and statin therapy. The incorporation of clinical decision support technology will be utilized to identify tailored opportunities for each CV risk reduction based on guideline recommendations for individual patients. Clinicians will be presented prompts with patient-specific recommendation(s) for further optimization of cardioprotective agents. These prompts will be conveyed by a Study Coordinator to responsible clinicians. The follow-up clinical prompts will be based on auditing of updated clinical parameters and medication use.
Education + facilitated referral to cardiometabolic team-based center for care optimization
Facilitated referral to a cardiometabolic team-based center
Each site will have access to clinicians caring for patients in structured, multidisciplinary cardiometabolic centers. Clinicians caring for patients randomized to this intervention strategy will receive a facilitated referral via the EHR together). If the clinician approves the referral, the patient will be referred to this local team-based comprehensive risk factor management clinic. All patients randomized to this group will be considered in this group whether or not a visit to the cardiometabolic center is completed.
Interventions
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Decision support
This implementation strategy will include the clinician education of the previous arm and apply "audit and feedback" of prior care to inform recommendations for future care. These suggestions will encompass 5 different domains based on eligibility and potential opportunity for an SGLT2i, GLP-1RA, angiotensin converting enzyme inhibitors (ACEi)/angiotensin-receptor blockers (ARB), antiplatelet or antithrombotic therapy, and statin therapy. The incorporation of clinical decision support technology will be utilized to identify tailored opportunities for each CV risk reduction based on guideline recommendations for individual patients. Clinicians will be presented prompts with patient-specific recommendation(s) for further optimization of cardioprotective agents. These prompts will be conveyed by a Study Coordinator to responsible clinicians. The follow-up clinical prompts will be based on auditing of updated clinical parameters and medication use.
Facilitated referral to a cardiometabolic team-based center
Each site will have access to clinicians caring for patients in structured, multidisciplinary cardiometabolic centers. Clinicians caring for patients randomized to this intervention strategy will receive a facilitated referral via the EHR together). If the clinician approves the referral, the patient will be referred to this local team-based comprehensive risk factor management clinic. All patients randomized to this group will be considered in this group whether or not a visit to the cardiometabolic center is completed.
Eligibility Criteria
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Inclusion Criteria
* ASCVD, defined as follows:
1. Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
2. Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization
3. Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization
Exclusion Criteria
* Currently receiving any SGLT2i or GLP-1RA
* Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA
* Currently receiving comfort care or enrolled in hospice
* Life expectancy \<1 year
* History of or plan for heart transplantation or ventricular assist device
* Current or planned hemodialysis
* Decompensated end stage liver disease
* History of Fournier's Gangrene
* Type 1 diabetes
* Prior history of diabetic ketoacidosis
* Pregnancy or active breastfeeding
* History of Pancreatitis or pancreatic cancer
* History of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2)
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
American College of Cardiology
OTHER
Responsible Party
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Locations
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Multiple sites nationwide
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00059648
Identifier Type: -
Identifier Source: org_study_id
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