Transform: Teaching, Technology, and Teams
This initiative supports a quality improvement effort evaluating the use of strategies (including technology-based decision support, referral to a virtual GDMT team, and general educational tools/resources for clinicians and patients) to improve use of guideline-directed therapeutics known to lower cardiovascular (CV) events among patients with cardiovascular diseases of heart failure, atrial fibrillation and type 2 diabetes (T2D)/ASCVD with a specific focus on underserved populations and those with a history of health care disparities.
Conditions:
🦠 Heart Failure 🦠 Type 2 Diabetes 🦠 Atrial Fibrillation
🗓️ Study Start (Actual) 30 September 2022
🗓️ Primary Completion (Estimated) 31 December 2023
✅ Study Completion (Estimated) 31 December 2023
👥 Enrollment (Estimated) 750
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Amarillo, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Age ≥18 years
    • 2. Personal access to a computer and/or Smartphone for app download
    • 3. Heart Failure (reduced and preserved ejection fraction) AND/OR
    • 4. Atrial Fibrillation with CHA2DS2-VASc score greater than or equal to 2 in men and greater than or equal to 3 in women AND/OR
    • 5. T2D and ASCVD, defined as follows:
    • 1. Known CAD, prior ACS, or coronary artery revascularization
    • 2. Prior TIA/stroke or known carotid or intracerebral atherosclerosis
    • 3. Prior PAD including requiring revascularization

    Exclusion Criteria:

    • All patients
    • 1. Current or anticipated participation in an interventional clinical trial of a drug/device
    • 2. Currently receiving comfort care or enrolled in hospice
    • 3. Life expectancy \<1 year
    • 4. Pregnancy or active breastfeeding
    • 5. Current or anticipated participation in an interventional clinical trial (other than TRANSFORM3 GDMT)
    • 6. Patients without a clinical encounter within three years of study start date
    • Heart Failure patients:
    • 1. History of or plan for heart transplantation or left ventricular assist de-vice
    • 2. Palliative chronic inotropic therapy
    • 3. NYHA Class 4 heart failure
    • Atrial Fibrillation patients:
    • 1. Current prescription for OAC
    • 2. Reversible cause of atrial fibrillation, such as post-cardiothoracic surgery or thyrotoxicosis
    • 3. History of ischemic stroke in prior 7 days
    • 4. Transient ischemic attack in prior 3 days
    • 5. Platelet count \<70,000/ml
    • 6. Hemoglobin concentration \<8g/dl
    • 7. History of or condition associated with increased bleeding risk, such as hemophilia
    • 8. Major surgical procedure or trauma within 14 days
    • 9. Clinically significant gastrointestinal bleeding within 8 weeks
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 September 2022
  • First Submitted that Met QC Criteria 5 October 2022
  • First Posted 10 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 October 2022
  • Last Update Posted 10 October 2022
  • Last Verified September 2022