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Transform CV Risk in Diabetes (CVRiD)

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision support
Facilitated referral to a cardiometabolic team-based center
Sponsored by
American College of Cardiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

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

Inclusion Criteria: T2D diagnosis in the medical record ASCVD, defined as follows: Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization Exclusion Criteria: Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19) 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)

Sites / Locations

  • Multiple sites nationwideRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Education alone

Education + decision support to provide suggestions for care optimization

Education + facilitated referral to cardiometabolic team-based center for care optimization

Arm Description

Outcomes

Primary Outcome Measures

New prescription of a SGLT2i and/or GLP-1RA
Proportion of treatment-naïve patients who are newly prescribed a SGLT2i and/or GLP-1RA over 9 months in the facilitated referral group (Arm C) versus usual care group (Arm A)

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
July 13, 2023
Sponsor
American College of Cardiology
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05948969
Brief Title
Transform CV Risk in Diabetes
Acronym
CVRiD
Official Title
Transform CV Risk in Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American College of Cardiology
Collaborators
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (CV) in patients with type 2 diabetes (T2D).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education alone
Arm Type
No Intervention
Arm Title
Education + decision support to provide suggestions for care optimization
Arm Type
Active Comparator
Arm Title
Education + facilitated referral to cardiometabolic team-based center for care optimization
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Decision support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Facilitated referral to a cardiometabolic team-based center
Intervention Description
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.
Primary Outcome Measure Information:
Title
New prescription of a SGLT2i and/or GLP-1RA
Description
Proportion of treatment-naïve patients who are newly prescribed a SGLT2i and/or GLP-1RA over 9 months in the facilitated referral group (Arm C) versus usual care group (Arm A)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: T2D diagnosis in the medical record ASCVD, defined as follows: Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization Exclusion Criteria: Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19) 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shilpa Patel
Phone
2023756354
Email
SPatel@acc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jack Reilly
Phone
202
Email
JReilly@acc.org
Facility Information:
Facility Name
Multiple sites nationwide
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shilpa Patel
Email
SPatel@acc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Transform CV Risk in Diabetes

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