Clinical trial NCT05572814: Transform: Teaching, Technology, and Teams
Official title: TRANSFORM3: Evaluation of Implementation Strategies of Teaching, Technology, and Teams to Optimize Medical Therapy in Cardiovascular Disease (T3)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Type 2 Diabetes
Atrial Fibrillation
Lead sponsor: American College of Cardiology
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adoption of evidence-based CV-risk reduction and disease management therapies for HF, AF, and T2D/ASCVD. This data will be found in the patient's medical record.
timeFrame: 9 months
Secondary outcomes:
measure: Quality of Life Outcome-MMA-4
timeFrame: Study duration up to 1 year.
measure: Quality of Life Outcome-KCCQ-12
timeFrame: Study duration up to 1 year.
measure: Quality of Life Outcome-PAM
timeFrame: Study duration up to 1 year.
Other outcomes:
Locations:
city: Amarillo
country: United States
facility: Cardiology Center of Amarillo
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: James MD Januzzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Ankeet S Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Andrew Oseran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Megan Welch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Jagmeet Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mass General Brigham
name: Muthiah Vadduganathan, MD
role: PRINCIPAL_INVESTIGATOR
References: