Transform: Teaching, Technology, and Teams (T3)

American College of Cardiology

Status: Enrolling

Conditions: Atrial Fibrillation; Type 2 Diabetes; Heart Failure

Treatments: Behavioral: Referral; Behavioral: Decision Support

Study type: Interventional

Funder types: Other

Identifiers

NCT05572814

59648

Details and patient eligibility

About

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.

Full description

TRANSFORM3 is a Quality Improvement initiative conducted in parallel to the current TRANSFORM CVRiD study and aligned with its goals of using a real-world population study to enable the American College of Cardiology Foundation ("ACCF") to better identify impactful ways to improve guideline directed medical therapy for patients. TRANSFORM3 is focused on improving GDMT use in underserved patients and patients with a history of health care disparities who have one or more of the following: heart failure, atrial fibrillation, and ASCVD/Type 2 diabetes.

There is a significant disconnect between increasing availability of effective and safe therapeutics that significantly reduce CV event risk in patients with Heart Failure, T2D and ASCVD, and Atrial Fibrillation-and clear guideline recommendations endorsing these therapies-but very low adoption in clinical practice with the majority of eligible patients that are most likely to benefit from these therapies not receiving them. A high proportion of patients have more than one of these conditions further reducing the chances of receiving optimal guideline directed medical therapy and avoiding the CV events they are designed to prevent.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 3 patient groups

Usual Care

No Intervention group

Description:

Teaching - CardioSmart Resources + Clinician Education

Decision Support

Active Comparator group

Description:

Technology - Facilitated Solution (Existing Team)

Treatment:

Behavioral: Decision Support

Referral

Active Comparator group

Description:

Teams - Protocol-Supported Team, (Virtual GDMT Team)

Treatment:

Behavioral: Referral